Wednesday March 4Th, 2020 Loews Coronado Bay Resort, San Diego, California

Monday March 2nd – Wednesday March 4th, 2020 Loews Coronado Bay Resort, San Diego, California

Presents

Contents Americas Antibody Congress 2020 ...... 3 Speakers ...... 3 Day 1 – Monday March 2nd 2020 ...... 7 Day 2 – Tuesday March 3rd 2020 ...... 16 Day 3 – Wednesday March 4th 2020 ...... 28 World Immunotherapy Congress USA 2019 ...... 35 Speakers ...... 35 Day 1 – Monday March 2nd 2020 ...... 39 Day 2 – Tuesday March 3rd 2020 ...... 49 Day 3 – Wednesday March 4th 2020 ...... 64 World Biosimilar Congress USA 2020 ...... 71 Advisory board ...... 71 Confirmed speakers...... 71 Workshop speakers ...... 73 Day 1 – Monday, March 2nd 2020 ...... 74 Day 2 – Tuesday, March 3rd 2020 ...... 77 Day 3 – Wednesday, March 4th 2020 ...... 82 Festival of Biologics USA - Workshop agenda ...... 86 Day 1 - Monday March 2nd 2020 ...... 86 Day 2 - Tuesday March 3rd 2020 ...... 87

Americas Antibody Congress 2020

Advisory board Marilyn Kehry, Vice President, Cell and Functional Biology, AnaptysBio Jeffrey Froude, Major, Stm, Vaccines and Therapeutics Division, Defence Threat Reduction Agency Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme John Delaney, Director, Research Technologies and Collaborations, Amgen Andrew Korytko, Research Advisor, Group Leader, Protein Engineering, Eli Lilly and Company Vaughn Smider, Professor, The Applied Biomedical Science Institute Jae Sly, Chief Business Officer, LigaTrap Technologies LLC

Speakers Aaron Sato, Chief Scientific Officer, Twist Biopharma, a division of Amrik Basran, Chief Scientific Officer, Avacta Twist Bioscience Amy Jenkins, Programme Manager, DARPA Al Tsang, Chief Scientific Officer, Precision Biologics Andrea Ferrante, Principal Research Scientist, Eli Lilly and Company Alexey Berezhnoy, Scientist II, MacroGenics Andres Perez Bay, Senior Staff Scientist, Regeneron

Andrew Korytko, Research Advisor, Group Leader, Protein Elizabeth Brunk, Postdoc Fellow, UCSD Moores Cancer Center Engineering, Eli Lilly and Company Erica Ollmann Saphire, Professor, La Jolla Institute for Immunology Andrew Polson, Principal Scientist, Genentech Ethan Laudermilch, Post-Doc, Albert Einstein College of Medicine Andrew Tsourkas, Professor of Bioengineering, University of Eugene Zhukovsky, Chief Scientific Officer, BIOMUNEX Pennsylvania Pharmaceuticals Anthony Mire-Sluis, Head of Global Quality, AstraZeneca Ezio Bonvini, Chief Scientific Officer, MacroGenics Anton Rosenbaum, Senior Scientist, Clinical Immunology & Fabiana Zappala, PhD Student, University of Pennsylvania Bioanalysis, AstraZeneca Feng Wang, Associate Director, Principal Investigator, Institute of Ariel Wirchnianski, PhD Candidate, Albert Einstein College of Biophysics, Chinese Academy of Sciences Medicine Francisco Ylera, R&D Team Leader, New Technologies, Bio-Rad Arunan Kaliyaperumal, Research Fellow, Eli Lilly and Company Laboratories Bellos Hadjivassiliou, Senior Scientist, Bristol-Myers Squibb Gary Starling, Associate Vice President, Protein Science, Merck Bob DuBridge, Senior Vice President of Research Discovery, Maverick Greg Babcock, Vice President, Research, Visterra Inc Therapeutics Gregory Weiss, Professor, University of California Irvine Brandon Dekosky, Assistant Professor, The University of Kansas Gunnar Kaufmann, Chief Scientific Officer, Oncternal Therapeutics Brandon Ruotolo, Professor, Chemistry, University of Michigan Haruki Hasegawa, Principal Scientist, Department of Therapeutic Brian Kay, Professor, Department of Biological Sciences, LAS Discovery, Amgen Distinguished Professor & University Scholar, University of Illinois at Harun Rashid, Senior Principal Scientist, Molecular Technology, Ambrx Chicago Helen Schiltz, Program Officer, Therapeutics Development, National Bronwyn M. Gunn, Assistant Professor, Paul G. Allen School of Global Institute of Health, NIAID Animal Health at Washington State University Hiroaki Suga, Professor, The University of Tokyo Bruce Keyt, CSO, IGM Biosciences Hongshan Li, Marketing Applications Manager, FortéBio C. Russell Cruz, Assistant Professor, Children’s National Hospital Ian Wilson, Hansen Professor of Structural Biology, Skaggs Institute for Chad Swanson, Senior Director, Neurology Business Group, Eisai Chemical Biology, The Scripps Research Institute Christopher Bahl, Head of Protein Design, Institute for Protein Isabelle Turbica, Associate Professor, Paris-Sud University Innovation Itay Levin, Director of Antibody Engineering, Biolojic Design David Boucher, Chief, Antivirals & Antitoxins, Biomedical Advanced Ivan Mascanfroni, Senior Scientist III, Immunology Biologics, Abbvie Research and Development Authority (BARDA) Bioresearch Centre David Busch, Senior Scientist, Merck Jack Ragheb, Senior Medical Fellow, Immunology, Eli Lilly & Company David Dornan, Senior Vice President of Research, Bolt Biotherapeutics Jae Sly, Chief Business Officer, LigaTrap Technologies LLC David Fontana, Head Strategic Alliance & JCAR017 Program Lead, Juno James Legg, Vice President, Research & Development, Crescendo Therapeutics Biologics Dawn Wofford, Regulatory Affairs Director, Cytovance Biologics Jared Delmar, Scientist I, AstraZeneca Denise Haslwanter, Research Fellow, Albert Einstein College of Javier Chaparro-Riggers, Executive Director, Pfizer Medicine Dian Su, Scientist, Genentech Jeffrey Froude, Major, Stm, Vaccines and Therapeutics Division, Derek Wilson, Director, Wilson Lab, York University Defence Threat Reduction Agency Elisabeth Nyakatura, Research Assistant Professor, Albert Einstein Jintang He, Scientist, Genentech College of Medicine Joan Shen, Head of Research and Development, I-Mab Biopharma

Johannes Brozy, Senior Associate Scientist, Bite Technology, Amgen Partha Chowdhury, Senior Director and Head, Antibody Discovery, John Delaney, Director, Research Technologies and Collaborations, Sanofi Genzyme Amgen John Hood, Chairman, Endeavour Biomedicines Pascal Touchon, President and CEO, Atara Biotherapeutics John Lambert, Consultant, Honorary Professor, Queen’s University, Patrick Wilson, Professor, Department of Medicine/Rheumatology, Belfast, Former CSO, ImmunoGen The University of Chicago John M. Burke, Co-Founder, President and CEO, Applied Biomath Petra Verdino, Principal Scientist, Eli Lilly and Company Jon Strauss, Director of CMC, Calibr, a division of Scripps Research Philip Tagari, Vice President, Research, Amgen Jonathan Davis, Head of Discovery, Invenra Philipp Spycher, Founder Fellow, Paul Scherrer Institut Kartik Chandran, Associate Professor, Department of Microbiology & Philippe Billiald, Full Professor, University Paris-Saclay, Scientific Immunology, Albert Einstein College of Medicine Advisor and Co-Founder, Acticor Biotech Kevin Johnson, Partner, Medixci Qiang (Shawn) Chen, Professor, The Biodesign Institute and School of Krzysztof Masternak, Head of Discovery, Light Chain Bioscience – a Life Sciences, Arizona State University brand of Novimmune SA Qun Du, Scientist I, AstraZeneca Larry Lum, Professor, Director of Cellular Therapy, Scientific Director Rachel Overman, Deputy Join Product Manager, BIO 2, JPM CBRN of Bone Marrow Transplant, University of Virginia Medical Liviu Movileanu, Professor, Department of Physics, Syracuse Raja Ghosh, Professor, Chemical Engineering, McMaster University University Rajesh Krishnan, Senior Vice President, CMC and Manufacturing Lu Shan, Scientist II, ADPE, MedImmune Operations, Oncternal Therapeutics Marc Nasoff, Chief Scientific Officer, Fortis Therapeutics Ramana Doppalapudi, Director of Chemistry, Avidity BioSciences Marilyn Kehry, Vice President, Cell and Functional Biology, AnaptysBio Richard Ding, Director of Downstream Purification and Manufacturing, Marjorie Shapiro, Supervisory Biologics Office of Biotechnology AnaptysBio Products, CDER, FDA Richard Vachet, Department Head, Professor in Chemistry, University Mark Throsby, CSO, Merus of Massachusetts Amherst Markku Saloheimo, Senior Principal Scientist, VTT Technical Research Romesh Rao, Research Associate III, Seattle Genetics Centre of Finland Roy Baynes, Senior Vice President and Head Global Clinical Martin Naradikian, Postdoctoral Fellow, La Jolla Institute for Development, Chief Medical Officer, Merck Research Laboratories Immunology Sandeep Kumar, Senior Research Fellow, Biotherapeutics, Boehringer Michael Yellin, Vice President of Clinical Science, Celldex Ingelheim Therapeutics Sandra DePorter, Investigator II, Novartis GNF Michaela Lantz, Scientist, Sanofi Sarah Cox, Associate Director of Biologics Discovery, GNF Mike Schopperle, Chief Scientific Officer, CureMeta Sebastian Meyer, COO, Numab Innovation AG Nathan Trinklein, Chief Technology Officer, Teneobio Sebastian Stolzenberg, PostDoc Project Leader, Free University of Nicholas Agard, Scientist, Genentech Berlin Nina Prak, Professor of Pathology and Laboratory Medicine, Perelman Senior Representative, Abcellera School of Medicine, University of Pennsylvania Senior Representative, Abzena Ning Ding, Group Leader, Immunology Discovery Group, Genentech Senior Representative, Alivamab and Ablexis Olapado Yeku, Assistant Clinical Attending, Massachusetts General Senior Representative, Biocytogen Hospital Senior Representative, Schrödinger

Stan Fleming, Founding Managing Partner, Forward Ventures Jack Ragheb, Senior Medical Fellow, Immunology, Eli Lilly & Company Stefan Duebel, Director, Technical University Braunschweig Julie Gerberding, Executive Vice President, Communications, Global Steven Deitcher, President, CEO and Board Member, RadImmune Policy, and Population Health & Chief Patient Officer, Merck Therapeutics Kevin Johnson, Partner, Medixci Susan Cellitti, Associate Director, Biotherapeutics, GNF Larry Lum, Professor, Director of Cellular Therapy, Scientific Director Susan Sharfstein, Professor of Nanobioscience, College of Nanoscale of Bone Marrow Transplant, University of Virginia Science and Engineering, SUNY Polytechnic Institute Marc Nasoff, Chief Scientific Officer, Fortis Therapeutics Tarik Dabdoubi, Team Leader, In Vivo Antibody Discovery, Sanofi Steven Corn, Founder and CEO, Metis Advocacy Tawnya Flick, Principal Scientist, Amgen Stan Fleming, Founding Managing Partner, Forward Ventures Thomas Weber, Application Team Leader USA, Dynamic Biosensors Tina Kiffer Bay, Research Investigator II, GNF Tony Polverino, Chief Scientific Officer, Zymeworks Torbjörn Gräslund, Professor, Medical Protein Technology, KTH Royal Institute of Technology Toshimitsu Uenaka, President, Epochal Precision Anti-Cancer Therapeutics (EPAT), Eisai Tracey Mullen, Chief Operating Officer, Abveris Vadim Klyushnichenko, VP of Pharmaceutical Development & Quality, Calibr, a division of Scripps Research Vaughn Smider, Professor, The Applied Biomedical Science Institute Vinodh Kurella, Senior Scientist II, Antibody Discovery and Designs, Voyager Therapeutics Vu Truong, Founder, Chief Executive Officer and Director, Aridis Pharmaceuticals Weifeng Liu, Senior Scientist, Pfizer Werner Meier, CSO, Revitope Oncology Yanay Ofran, Founder and Chief Executive Officer, Biolojic Design Yongku Cho, Assistant Professor, University of Connecticut Zhaorui (Ray) Zhang, Senior Scientist II, AbbVie (135/150)

Workshop moderators Andrea Ferrante, Principal Research Scientist, Eli Lilly and Company Arunan Kalitaperumal, Research Fellow, Director, Eli Lilly and Company Brenda Hann, Director, Clinical Trials Operations, Stanford Medicine Eve Bukowski, Vice President, Patient Advocacy, Education & Outreach, California Life Sciences Association (CLSA)

Day 1 – Monday March 2nd 2020 7:30am Registration opens 8:30am Doors open Opening keynotes Next generation antibody formats Chaired by: Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme (invited) 9:00am Opening remarks from Terrapinn 9:05am Chair’s opening remarks 9:10am Title TBA Philip Tagari, Vice President, Research, Amgen (CONFIRMED) 9:35am Title TBA Erica Ollmann Saphire, Professor, La Jolla Institute for Immunology (CONFIRMED) 10:00am Bispecific antibody innovations to transform the standard of care in HER2-expressing cancers • Leading the next wave of biotech breakthroughs in oncology through bispecific, multifunctional antibodies and ADCs • Azymetric and ZymeLink: innovative bispecific therapeutic platforms • ZW25: a HER2-targeted bispecific antibody that offers unique mechanisms of action and is rapidly advancing in the clinic for patients with gastric and breast cancer • ZW49: a bispecific antibody-drug conjugate with improved efficacy and tolerability compared with leading HER2-targeted ADCs

Tony Polverino, Chief Scientific Officer, Zymeworks (CONFIRMED) 10:25am Morning networking break 11:30am Plenary roundtable session 15 senior level tables hosted by thought leaders on key challenges and opportunities in antibody drug discovery and development. Participants are invited to join the group discussions on a topic of importance to them. The round table session will have two rotations, each lasting 35 minutes. TABLE 1 TABLE 2 TABLE 3 Bioanalytical considerations for pharmacokinetic Choosing the right CMO to manufacture your product, Third generation antibody discovery and assessments of novel biotherapeutic modalities balancing cost, time and quality engineering platforms- Microfluidics and Vadim Klyushnichenko, VP of Pharmaceutical computational discovery Anton Rosenbaum, Senior Scientist, Clinical Development & Quality, Calibr, a division of Scripps Partha Chowdhury, Senior Director and Head, Immunology & Bioanalysis, AstraZeneca (CONFIRMED) Research (CONFIRMED) Antibody Discovery, Sanofi Genzyme (CONFIRMED)

TABLE 11 TABLE 5 TABLE 6 Cytosolic delivery of proteins Trends in protein engineering and molecule design Generating assay reagents through phage-display Sandra DePorter, Investigator II, Novartis GNF Andrew Korytko, Research Advisor, Group Leader, Brian Kay, Professor, Department of Biological (CONFIRMED) Protein Engineering, Eli Lilly and Company Sciences, LAS Distinguished Professor & University (CONFIRMED)

Scholar, University of Illinois at Chicago (CONFIRMED) TABLE 7 TABLE 8 TABLE 9 Round table available Future digital opportunities for pharma and academia CMC for antibody therapeutics to jointly shape healthcare Jon Strauss, Director of CMC, Calibr, a division of Sebastian Stolzenberg, PostDoc Project Leader, Free Scripps Research (CONFIRMED) University of Berlin (CONFIRMED) TABLE 10 The current status and future outlook for antibody drug conjugates (ADCs) Susan Cellitti, Associate Director, Biotherapeutics, GNF (CONFIRMED) 12:40pm Networking lunch Workshop: Identifying early stage assets in academia Comparing strategies and challenges of bispecific antibody infusion 12:35pm – • Technology Transfer databases – Identifying Potential Drug Discovery Programs • What is an ideal bispecific antibody for different approaches? 1:20pm • In-licensing expectations • What's the pathophysiology of side effects related to different routes • Academic advisory roles of delivery of bispecific antibody infusions? • Establishing a firewall for intellectual property rights • What are the advantages and disadvantages of different approaches • using bispecific antibodies? Marc Nasoff, Chief Scientific Officer, Fortis Therapeutics (CONFIRMED) • What are the challenges preventing clinical effectiveness using the various platforms?

Larry Lum, Professor, Director of Cellular Therapy, Scientific Director of Bone Marrow Transplant, University of Virginia (CONFIRMED) Workshop: AI for antibody drug discovery and development 1:25pm – Sandeep Kumar, Senior Research Fellow, Biotherapeutics, Boehringer Ingelheim (reserved) 1:55pm Protein engineering Bispecifics discovery Armed antibodies mAbs and novel formats Technology showcase Chaired by: Jae Sly, Chief Chaired by: John Delaney, Chaired by: John Lambert, Chaired by: Gary Starling, Business Officer, LigaTrap Director, Research Technologies Consultant, Honorary Professor, Associate Vice President, Technologies LLC (CONFIRMED) and Collaborations, Amgen Queen’s University Belfast, Protein Science, Merck (CONFIRMED) Former CSO, ImmunoGen (CONFIRMED) (CONFIRMED) 2:00pm Title TBA COBRA – A new class of Designing effective antibody- Discovery of a PD-1 Reserved for supporting partner. If conditionally active, T-cell drug conjugates: What have we checkpoint agonist antibody you are interested in being involved, please contact Derek Senior Representative, Abcellera engaging bispecifics for the learned in twenty years, since for Cavanagh at (CONFIRMED) treatment of solid tumors the first approval of Mylotarg®?

• Bispecific T cell engagers • Twenty years ago, the first autoimmune/inflammatory [email protected] or have demonstrated high ADC (Mylotarg®)was disease +44 (0)207 092 1297 potency and good efficacy approved and marked for • An anti-PD-1 antibody in the treatment of certain treating AML; however 10 that mimics activity of heme malignancies years later (2010), it was natural checkpoint • The use of this class of withdrawn from the US and ligands and down- therapeutics to treat solid EU markets following a failed modulates T-cell tumors has been more phase 3 trial responses has the challenging • The approvals of Adcetris® in potential to restore and • Maverick has developed a 2011 for treating HL and maintain immune new type of conditionally ALCL, and Kadcyla® in 2013 balance in autoimmune active T cell engager for treating HER2+ and inflammatory • Data will be presented metastatic breast cancer, diseases outlining the potency and rejuvenated widespread • ANB030 is a humanized conditionality of these interest in the field. IgG1/κ anti-PD-1 agonist molecules • While there are many factors antibody that is non- involved in creating an blocking for PD-L1 Bob DuBridge, Senior Vice effective ADC (right target, binding and requires Fcγ President of Research right antibody, right linker receptor engagement for Discovery, Maverick properties and attachment its functional inhibitory Therapeutics (CONFIRMED) site(s), right payload, right activity in solution patients), getting the factors • Signalling mechanism right can create ADCs that studies show similar can become important effects for ANB030 and medicines for treating cancer PD-L1-Fc and other diseases. Marilyn Kehry, Vice John Lambert, Consultant, President, Cell and Functional Honorary Professor, Queen’s Biology, AnaptysBio University, Belfast, Former CSO, (CONFIRMED) ImmunoGen (CONFIRMED) 2:20pm Assembling antibodies from Optimization of a bispecific Antibody-Drug-Conjugates to Title TBA Reserved for supporting partner. If modules using protein ligation: a anti-CD3 antibody-folate bio- cellular reprogrammed targets in you are interested in being involved, please contact Derek new versatile engineering conjugate for the treatment of cancer Senior Representative, Cavanagh at toolbox ovarian cancer • Cellular Reprogramming is an Biocytogen (CONFIRMED) [email protected] or • Antibody assembly by • We report the optimization emerging theory on the +44 (0)207 092 1297 protein ligation of an anti-CD3 Fab-Folate origin, development and bio-conjugate that targets progression of cancer

• Site-specific antibody cytotoxic T cells to folate • Cellular Reprogramming labeling receptor positive (FR+) results in malignant cells • Multiplex by Fc switching tumor cells for optimal with stemness properties • Antibody engineering efficacy, reduced toxicity and clinically untested new toolbox and optimal therapeutic cancer targets pharmacokinetic (PK) • CM-09 is and ADC to a Francisco Ylera, R&D Team properties reprogrammed target, TRA- Leader, New Technologies, Bio- • The optimized bio- 1-60, in metastatic and Rad Laboratories (CONFIRMED) conjugates showed potent aggressive cancers and selective in vitro activity, improved serum Mike Schopperle, Chief Scientific half-life, and potent in vivo Officer, CureMeta (CONFIRMED) activity in xenograft mouse models. • This semi-synthetic approach is likely to be applicable for the generation of additional anti-CD3 bispecific bio- conjugate agents using small molecule ligands selective for other TAAs

Harun Rashid, Senior Principal Scientist, Molecular Technology, Ambrx (CONFIRMED) 2:40pm Novel monomeric Fc platform – Biophysical analysis of Overcoming limitations of Antibody discovery platform Reserved for supporting partner. If engineering and applications bispecific binders with dual- current Antibody-Drug to mine out the memory B you are interested in being involved, please contact Derek • Monovalent fusion proteins signal biosensors Conjugates (ADCs) by a novel cell repertoire using flow Cavanagh at are often a necessary drug • Interactions of bispecific linker technology cytometry single-cell sorting [email protected] or format for optimal structure binders with two different • Introduction of novel linker technology +44 (0)207 092 1297 and activity profiles antigens technology for antibody-drug • Novel platform that • We present our novel • Analysis of binding kinetics conjugates (ADCs) enables large-scale monovalent fusion platform and avidity • Efficient site-specific payload functional interrogation in target validation, lead attachment to native of the natively paired discovery, and structure antibodies (no engineering, VH:VL antibody insights DAR2, DAR4) will be shown repertoire of immunized

• Implications for the • Comprehensive in-vitro and human immunoglobulin Lu Shan, Scientist II, ADPE, engineering of binding in-vivo data will be transgenic mice MedImmune (CONFIRMED) selectivity presented • We will describe the use of multi-parameter flow Thomas Weber, Application Philipp Spycher, Founder Fellow, cytometry single cell Team Leader USA, Dynamic Paul Scherrer Institut sorting technology for the Biosensors (CONFIRMED) (CONFIRMED) generation of antigen- specific antibodies with desirable characteristics from IgG+ memory B cell compartment • A case study will be presented, where a rare highly potent neutralizing antibody for the treatment of inflammatory diseases was identified

Tarik Dabdoubi, Team Leader, In Vivo Antibody Discovery, Sanofi (CONFIRMED) 3:00pm Engineering proteins Host- and virus-directed The bumblebee cannot fly Anti-ROR1 mAb Cirmtuzumab Reserved for supporting partner. If therapeutics and antibodies to bispecific antibodies as broad- • Extracellular deposits of - Novel Synergistic you are interested in being involved, please contact Derek enable efficient cytosolic spectrum anti-Ebola intracellular antigens make Combinations For Cavanagh at delivery with cationic lipids therapeutics attractive targets for Hematological Malignancies [email protected] or • Photoreactive antibody- • Multiple members of the antibody-targeted radiation and Solid Tumors +44 (0)207 092 1297 binding domains enable the filovirus family are therapy • Cirmtuzumab targets site-specific attachment of associated with human • Alpha particle emitters may ROR1, an oncofetal anionic polypeptides to disease be optimal for the treatment antigen expressed on nearly any off-the-shelf • Human monoclonal of rapidly progressive both liquid and solid antibody antibodies have shown cancers tumors • Protein therapeutics and therapeutic promise but • Liquid radiation may be • Cirmtuzumab inhibits antibodies that are fused or display only clade-specific synergistic with checkpoint Wnt5a signalling and conjugated to anionic activity inhibitors reverses cancer stemness polypeptides can be • We describe multiple • Cirmtuzumab and complexed with cationic bispecific antibody-based chemotherapy can act lipids

• Cationic lipids facilitate the approaches with potent Steven Deitcher, President, CEO synergistically clinical trial efficient escape of proteins and broad anti-filovirus and Board Member, RadImmune of the combination is and antibodies from activity Therapeutics (CONFIRMED) underway endosomes/lysosomes and • At least one strategy • Clinical trials using enable their delivery to the affords unprecedented combination therapy are cytosol pan-filovirus neutralization underway

Andrew Tsourkas, Professor of Kartik Chandran, Associate Gunnar Kaufmann, Chief Bioengineering, University of Professor, Department of Scientific Officer, Oncternal Pennsylvania (CONFIRMED) Microbiology & Immunology, Therapeutics (CONFIRMED) Albert Einstein College of Medicine (CONFIRMED) 3:20pm Networking break Workshop: Overview of therapeutic protein immunogenicity workshop 3:30pm – Jack Ragheb, Senior Medical Fellow, Immunology, Eli Lilly & Company (CONFIRMED) 4:00pm Andrea Ferrante, Principal Research Scientist, Eli Lilly and Company (CONFIRMED) Arunan Kaliyaperumal, Research Fellow, Eli Lilly and Company (CONFIRMED) Protein engineering Bispecifics discovery Armed antibodies mAbs and novel formats Technology showcase Chaired by: Jae Sly, Chief Chaired by: Jonathan Davis, Chaired by: Andres Perez Bay, Chaired by: Vaughn Smider, Business Officer, LigaTrap Head of Discovery, Invenra Senior Staff Scientist, Regeneron Professor, The Applied Technologies LLC (CONFIRMED) (CONFIRMED) (CONFIRMED) Biomedical Science Institute (CONFIRMED) 4:10pm IgMs as therapeutic agonists From constrained peptides to CD46 – A novel Title TBA Reserved for supporting partner. If • IgMs have 10 or 12 binding neobiologics immunomodulatory target for you are interested in being involved, please contact Derek subunits and a unique • A novel approach to late stage mCRPC and multiple Senior Representative, Cavanagh at ‘mushroom’ shape that generate multi-specific myeloma Alivamab and Ablexis [email protected] or defines the arrangement of biologics/antibodies (CONFIRMED) +44 (0)207 092 1297 cell-surface bound ligands • Maintaining the bivalency • FOR46 is an ADC targeting a • We show this multivalent of antibodies novel immune modulatory engagement agonizes • A simply and robust tumor target (CD46) for the clinical targets not technology treatment of metastatic addressable by simple IgGs Prostate Cancer (mCRPC) and • Further engineering and Hiroaki Suga, Professor, The Multiple Myeloma (MM) characterization of IgMs University of Tokyo • Discovery of the target helps define their suitability (CONFIRMED) • Preclinical efficacy in mCRPC across multiple therapeutic and MM spaces

• Development of the FOR46 Nicholas Agard, Scientist, drug product Genentech (CONFIRMED) • 2 separate Phase 1 clinical trials initiated

Marc Nasoff, Chief Scientific Officer, Fortis Therapeutics (CONFIRMED) 4:30pm de novo design of G protein Title and speaker TBA MORAb-202, a folate receptor Biology and applications of Reserved for supporting partner. If mimetics: generalizable tools for alpha-targeted antibody-drug long CDR3 antibodies you are interested in being involved, please contact Derek allosteric control of G protein- Pavel Strop, Senior Director, conjugate, loaded with • Cows make ultralong Cavanagh at coupled receptors Protein Engineering, Bristol- HALAVEN® (eribulin) as payload CDR3s of up to 70 amino [email protected] or • We leverage high- Myers Squibb (invited) • MORAb-202 is the first ADC acids in length +44 (0)207 092 1297 throughput laboratory which is loaded with • These CDR3s can bind automation to accelerate HALAVEN® (eribulin) as novel and important protein production and payload epitopes antibody engineering. We • HALAVEN® is an approved • Ultralong CDR3s can be are particularly interested in drug which exhibits unique engineered with bioactive G protein coupled receptors effects on tumor peptides and cytokines (GPCRs) microenvironment • Here, I describe the • The preclinical and clinical Vaughn Smider, Professor, computational de novo Phase 1 interim data of The Applied Biomedical design and testing of protein MORAb-202 are discussed Science Institute affinity reagents that enable (CONFIRMED) generalized control over Toshimitsu Uenaka, President, GPCR conformation Epochal Precision Anti-Cancer • These de novo G protein Therapeutics (EPAT), Eisai mimetics will enable us to (CONFIRMED) rapidly engineer functional antibodies for GPCRs

Christopher Bahl, Head of Protein Design, Institute for Protein Innovation (CONFIRMED) 4:50pm Antibodies with affinity switches BiTE® antibody constructs in Bispecific antibody-drug Title TBA Reserved for supporting partner. If • Allosteric module to regulate oncology and antiviral conjugates (ADCs) exploit the you are interested in being involved, please contact Derek antibody affinity applications tumour-specificity of HER2 and Cavanagh at

• Works under physiological • This presentation will give the trafficking properties of Senior Representative, Abzena [email protected] or conditions an update on Amgen’s BiTE APLP2 to improve on HER2-ADC (CONFIRMED) +44 (0)207 092 1297 • Demonstrated for different pipeline at the discovery, efficacy antibodies translational, and early • Intracellular trafficking of clinical stage of antibody-drug conjugates Stefan Duebel, Director, development (ADCs) is essential for ADC Technical University • We will also showcase antitumor effect Braunschweig (CONFIRMED) antiviral activity of BiTE • APLP2xHER2 bispecific antibody constructs in antibodies were generated, research that used the HER2 arm for surface binding and the low Johannes Brozy, Senior affinity APLP2 arm for Associate Scientist, Bite internalization/degradation Technology, Amgen • Two APLP2xHER2-ADCs (CONFIRMED) outperformed T-DM1 in IHC2+ models in vitro and in vivo and showed acceptable PK profile in APLP2 humanized mice

Andres Perez Bay, Senior Staff Scientist, Regeneron (CONFIRMED) 5:10pm Title TBA Title TBA Antibody oligonucleotide Plant-produced mAbs with Reserved for supporting partner. If conjugates for the treatment of improved Fc effector function you are interested in being involved, please contact Derek Sarah Cox, Associate Director of Jonathan Davis, Head of muscle disorders • Plant can produce mAb Cavanagh at Biologics Discovery, GNF Discovery, Invenra • Antibody oligonucleotide rapidly via transient [email protected] or (CONFIRMED) (CONFIRMED) conjugates for the treatment expression +44 (0)207 092 1297 of muscle disorders • Glycoengineering of plants allows the Ramana Doppalapudi, Director production of mAb with of Chemistry, Avidity BioSciences tailor-made glycosylation (CONFIRMED) on demand • Plant-made mAbs with homogenous human glycans have enhanced effector function and

efficacy against cancer and viral infection

Qiang (Shawn) Chen, Professor, The Biodesign Institute and School of Life Sciences, Arizona State University (CONFIRMED) 5:30pm Offsite drinks reception

Day 2 – Tuesday March 3rd 2020 8:00am Registration opens 8:30am Doors open Day 2 opening keynotes Combination therapies in antibodies and immunotherapy Chaired by: Roy Baynes, Senior Vice President and Head Global Clinical Development, Chief Medical Officer, Merck Research Laboratories (CONFIRMED) 9:00am Chair’s opening remarks Chaired by: Roy Baynes, Senior Vice President and Head Global Clinical Development, Chief Medical Officer, Merck Research Laboratories (CONFIRMED) 9:05am PD-1 antibodies are transforming cancer treatment both as monotherapy and in combination • Monotherapy activity has been established and is transforming treatment across a number of major cancers • Precision medicine has been deployed to identify patients most likely to respond and those for whom a combination approach might be preferred • Precision medicine has enabled prediction of potentially important combination therapies • Combination therapies are now beginning to transform treatment across a number of cancers • PD-1 antibodies have become foundational in cancer therapy

Roy Baynes, Senior Vice President and Head Global Clinical Development, Chief Medical Officer, Merck Research Laboratories (CONFIRMED) 9:25am Building a leading off-the-shelf, allogeneic T-Cell immunotherapy company • Epstein-Barr virus (EBV) is associated with a wide range of cancers and multiple sclerosis (MS) • Tab-cel® (tabelecleucel) is an off-the-shelf, allogeneic EBV T-cell immunotherapy in Phase 3 development for patients with EBV+ post-transplant lymphoma as well as other serious EBV-associated ultra-rare diseases • ATA188 is an off-the-shelf, allogeneic T-cell immunotherapy that targets EBV-infected B cells believed to play a role in the pathogenesis of MS • EBV T cells also have potential application as an off-the-shelf, allogeneic CAR T platform • ATA2271/ATA3271 are novel mesothelin-targeted CAR T programs incorporating next-generation technologies for patients with advanced solid tumors • Atara’s platform is supported by state-of-the-art T-cell manufacturing that is commissioned and qualified to support clinical development

Pascal Touchon, President and CEO, Atara Biotherapeutics (CONFIRMED) 9:45am Strategies for combination therapies with CD19 CARTs in NHL - lessons learned and future directions • CD19 CAR Ts have demonstrated notable activity in DLBCL, CLL, FL, pALL and other hematological malignancies with high overall response rates and durable CRs • However, a portion of patients either do not respond or their responses are not durable • Learnings from non-responders or CAR-T relapses are providing data into the multitude of potential resistance/suppression mechanisms • This presentation will review combination approaches being evaluated to overcoming resistance in CAR T to improve outcomes in NHL and provide insights for solid tumor approaches and the next wave of targets

• Quantitative Systems Pharmacology (QSP) is a mathematical modeling and engineering approach to translational medicine that aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms • Several examples will be shown which highlight QSP efforts to accelerate the discovery and development of best-in-class therapeutics and impact critical decisions, in the continuum from preclinical exploration to clinical research • Examples will include providing biological understanding, impact on new target proposals, lead generation, clinical candidate selection, IND support, and clinical trial go/no go decisions from industry

John M. Burke, Co-Founder, President and CEO, Applied Biomath (CONFIRMED) 10:25am Morning networking break Protein engineering Bispecifics discovery/development Novel indications for therapeutic Armed antibodies Antibodies for Chaired by: Petra Verdino, Chaired by: Mark Throsby, CSO, antibodies immunotherapy Principal Scientist, Eli Lilly and Merus (CONFIRMED) Chaired by: Ivan Mascanfroni, Chaired by: C. Russell Cruz, Company (CONFIRMED) Senior Scientist III, Immunology Assistant Professor, Biologics, Abbvie Bioresearch Children’s National Hospital Centre (CONFIRMED) (invited) 11:25am Phi – a parameter for Applying empirical screening to Title TBA ADME considerations & Title TBA quantifying the specificity of the discovery of tumor-targeted bioanalytical strategies for post-translational modification and immunomodulatory Chad Swanson, Executive pharmacokinetic Bruce Keyt, CSO, IGM site targeting antibodies bispecific antibodies Director, Neurology Business assessments of antibody- Biosciences (CONFIRMED) • A parameter termed phi • The attributes of Merus’s Group, Eisai (CONFIRMED) drug conjugates that quantifies the fraction enabling Biclonics technology • Overview of structural of specific binding signal in • The role of unbiased complexity of ADCs antibodies functional screening in • Current bioanalytical • A robust flow cytometry unlocking novel biology approaches commonly assay for measuring phi. • Case studies of clinical stage employed to assess • Application of the assay to programs discovered using a pharmacokinetics of measure the specificity of functional screening approach ADCs phospho-tau antibodies • Emerging bioanalytical • Validation results for 7 Mark Throsby, CSO, Merus tools for the assessment widely used phospho-tau (CONFIRMED) of ADC antibodies biotransformations

Yongku Cho, Assistant Anton Rosenbaum, Senior Professor, University of Scientist, Clinical Connecticut (CONFIRMED) Immunology & Bioanalysis, AstraZeneca (CONFIRMED)

11:45am Upstream expertise and high- Generating novel, differentiated WISP1 is a therapeutic target for Pave the road to drug the CDX-1140, a unique agonist resolution single B-cell profiling multi-functional biologics using liver fibrosis “undruggable”: anti-CD40 mAb for cancer for accelerated discovery of Humabody VH • WISP1 as well as MRTF Understanding the complex immunotherapy elusive and functionally • Crescendo has a proprietary activation are hallmarks of biotransformation of • CD40 plays key roles in relevant antibodies transgenic mouse platform for liver cirrhosis antibody-drug conjugates innate and adaptive • Antibody discovery for generation of fully human VH • WISP1 is an extracellular • Complex immune responses, and traditionally difficult targets domains (Humabody VH) with inducer of MRTF signaling biotransfromations of targeting CD40 can is facilitated by the use of excellent biophysical and myofibroblast motility next-generation ADCs promote tumor complex immunization properties • WISP1 deficient mice are • Advanced strategies, regression via multiple techniques and genetically • This platform is well suited to protected against established technologies and mechanisms modified hyperimmune the generation of formatted liver fibrosis progression applications in ADC • CDX-1140 is a fully mice multispecific therapeutics for • A novel WISP1 neutralizing biotransformation human IgG2 agonist • The Berkeley Lights Beacon Immuno oncology and other antibody halts established • Case study: novel and anti-CD40 mAb selected optofluidic platform is a therapeutic areas liver fibrosis progression and complex based on a linear dose single cell isolation and • The talk will describe recent promotes resolution by biotransformations of response and interrogation workhorse case studies and how inhibiting WISP1-MRTF axis in CBI ADCs and their hypothesized to achieve that allows for rapid, high- different discovery cascades a chronic liver injury model impact good systemic exposure resolution profiling of have been used to identify the and tumor penetration single antibody-secreting B- most potent formatted Ning Ding, Group Leader, Dian Su, Scientist, without dose-limiting cells molecules Immunology Discovery Group, Genentech (CONFIRMED) toxicity observed with • Case studies involving high • Different approaches will be Genentech (CONFIRMED) other potent agonist homology targets, cryptic described and compared anti-CD40 mAbs epitopes, and/or complex including isolation of panels of • CDX1140-01 is a Phase cell surface antigens will be single VH using display, NGS 1 dose-escalation study presented and early to format with tumor specific approaches expansion cohorts of Tracey Mullen, Chief Operating • Case studies will be described CDX-1140 alone or in Officer, Abveris (CONFIRMED) • Beyond bispecific into combination with CDX- trispecific 301, a potent dendritic cell growth factor, in James Legg, Vice President, patients with advanced Research & Development, cancer; preliminary data Crescendo Biologics (CONFIRMED) from the study will be presented

Michael Yellin, Vice President of Clinical Science,

Celldex Therapeutics (CONFIRMED) 12:05pm Title TBA A novel CD3-engaging DART® Title TBA ADCs with novel linker T cell redirecting antibody platform with enhanced drugs circuits: Bispecifics with a Elizabeth Brunk, Postdoc therapeutic window Vu Truong, Founder, Chief unique “AND” gate to Fellow, UCSD Moores Cancer • Cytokine release is associated Executive Officer and Director, Andrew Polson, Principal enhance tumor specificity Center (CONFIRMED) with CD3-induced T-cell Aridis Pharmaceuticals Scientist, Genentech • Harnessing the Immune activation; however, (CONFIRMED) (CONFIRMED) System, in particular dissociation of cytolytic and redirected T-cells to kill proliferative activities from tumor cells has cytokine release is feasible revolutionized cancer • A novel platform with treatment. However, improved features has been on and off-target developed through systematic toxicity limit the screening of affinity- therapeutic potential of modulated version of the these approaches CD3-binding arm • Revitope is developing T • Application of the technology cell redirecting antibody to liquid and solid tumor circuits that use dual- targets will be discussed targeting to deliver split Ezio Bonvini, Chief Scientific anti-CD3 paratopes to Officer, MacroGenics the tumor. (CONFIRMED) Reconstitution is only permitted after protease cleavage in the tumor microenvironment to remove the stabilizing dummy domain. This approach is designed to initiate and focus T cell mediated cytotoxic immunity accurately on the tumor sparing normal tissues • We will discuss protein engineering considerations, in vitro

and in vivo activity measurements, half-life and the use of quantitative systems pharmacology modelling approaches to aid mechanistic understanding

Werner Meier, CSO, Revitope Oncology (CONFIRMED) 12:25am Structure of the 4-1BB/4-1BBL A versatile Plug-and-Play tetra- Assessment of ADC from a Engineered antibody- complex and distinct binding Fab antibody platform, BiXAb, for big picture perspective: secreting T cells and functional properties of development of next generation intact MS analysis and • Brief historical overview utomilumab and urelumab bispecific antibodies with diverse protein conformation assay of antibody-secreting T • 4-1BBL:4-1BB complex set of mechanisms of action • Assessment of cell technology displays a classical 3:3 • BiXAb® possesses excellent developability of • Antibodies engineered structural organization with drug-like properties antibody-drug to mediate ADCC can be unique features. • Two platform showcases: conjugate (ADC) secreted by T cells • Utomilumab and Urelumab • BMX-002 for targeting of solid • Integrated mass • Results in HIV suggest recognize different tumors spectrometry platform linking innate epitopes of 4-1BB • BMX-101: for targeting of techniques including and adaptive • Utomilumab is a milder hematological malignancies native RPLC-MS and components via agonist than Urelumab and other cancers middle-down for direct antibodies is feasible analysis of intact ADC Weifeng Liu, Senior Scientist, Eugene Zhukovsky, Chief Scientific and subunits C. Russell Cruz, Assistant Pfizer (CONFIRMED) Officer, Biomunex • Protein conformation Professor, Children’s Pharmaceuticals (CONFIRMED) assay for the detection National Hospital of low-level (CONFIRMED) conformational change in ADC

Zhaorui (Ray) Zhang, Senior Scientist II, AbbVie (CONFIRMED) 12:45am Networking lunch Workshop: Biologics investor clinic

12:50pm – Kevin Johnson, Partner, Medixci (CONFIRMED) 1:20pm John Hood, Chairman, Endeavour Biomedicines (CONFIRMED) Stan Fleming, Founding Managing Partner, Forward Ventures (CONFIRMED) Protein engineering Bispecifics development Novel indications for therapeutic CMC, developability and Antibodies for Chaired by: Petra Verdino, Chaired by: Mark Throsby, CSO, antibodies manufacturability immunotherapy Principal Scientist, Eli Lilly and Merus (CONFIRMED) Chaired by: Ivan Mascanfroni, Chaired by: Rajesh Krishnan, Chaired by: Greg Babcock, Company (CONFIRMED) Senior Scientist III, Immunology Senior Vice President, CMC Vice President, Research, Biologics, Abbvie Bioresearch and Manufacturing Visterra Inc (CONFIRMED) Centre (CONFIRMED) Operations, Oncternal Therapeutics (CONFIRMED) 2:00pm Design of an antibody with Affimer therapeutics: a versatile A Systems Fc-Engineering Development and Structure-guided design of multiple specificity for two platform for the generation of approach to define functional optimization of a an IL-2-based therapeutic antigens bispecific immunotherapies humoral correlates of immunity quantitative Octet method that selectively activates • Will demonstrate the • An introduction to the human against Ebola virus for the AAV2 titration regulatory T cells properties of a multibody Affimer scaffold as a • Both Fab-mediated • Several novel IL-2 we designed: a natural therapeutic platform for the neutralization and Fc- Hongshan Li, Marketing mutations that enhance human IgG that specifically generation of potent mediated innate immune Applications Manager, selectivity of IL-2 for binds two unrelated antagonists of check point effector functions contribute FortéBio (CONFIRMED) Tregs will be discussed antigens inhibitors such as PD-L1 and to antibody-mediated • Enhanced half-life of • Will review challenges and LAG-3. protection from Ebola virus the IL-2 muteins in vivo opportunities in • With our anti-PDL1 and LAG-3 • Fc-engineering of therapeutic • Selective expansion of engineering of multiple Affimer proteins, we have antibodies may enhance Tregs in vivo, with specific antibody generated high affinity potency and efficacy modest to no activation • Will discuss protein bispecific formats against • We have developed a rapid of NK cells or Th cells engineering approaches for both human and mouse systems biology-inspired • Efficacy in disease design, selection, and checkpoints. The Affimer platform to generate libraries models of assessment of multiple molecules have been of functionally diverse autoimmunity specific antibodies formatted as Fc and in-line antibodies with identical Fab fusions. domains Greg Babcock, Vice Itay Levin, Director of Antibody • Using cell-based assays, we • The library can be evaluated President, Research, Engineering, Biolojic Design have shown that the for in vitro activity and Visterra Inc (CONFIRMED) (CONFIRMED) combination of PD-L1 and antibodies that represent LAG-3 blockade showed an unique functional profiles can increase in cytokine release be selected for further in vivo compared to monovalent testing blockade alone. Bronwyn M. Gunn, Assistant Professor, Paul G. Allen School of

Amrik Basran, Chief Scientific Global Animal Health at Officer, Avacta (CONFIRMED) Washington State University (CONFIRMED) 2:20pm Synthetic DNA technologies Selection of abBispecific modality Title TBA Phase appropriate GMP – a T cell engaging bispecific enable antibody discovery and for optimal tumor-anchored regulatory roadmap antibodies: Comparing optimization immune co-stimulation Elisabeth Nyakatura, Research • Introduce the Pfizer’s platforms • Utilizing its proprietary • Proof-of-concept studies Assistant Professor, Albert Regulatory Roadmap for • T-cell engaging DNA writing technology to demonstrate tumor-cell Einstein College of Medicine the Product Lifecycle: bispecific antibodies are create oligo pools, genes, conditional activation of the (CONFIRMED) from R&D, approaches a promising therapeutic and synthetic libraries, CD137 pathway by various during clinical phases approach for the Twist Pharma, a division of TAA x CD137 DART® and and requirements for treatment of multiple Twist Bioscience, provides TRIDENTTM proteins, commercial cancer types. the biotechnology industry including 5T4 x CD137, HER2 x manufacturing • Pfizer has developed with an end-to-end CD137 and PD-L1 x CD137 • CDMO approach: several Fc-containing T- antibody discovery solution • The TRIDENT format, bearing Common understanding cell engaging bispecific • This solution includes (1) a monovalent tumor targeting of Risks, Expectations & antibody platforms, panel of high diversity and bivalent CD137 binding, Activities which increase the half- synthetic antibody libraries provides an optimal • GMP Requirements & life and allows for (Fab, scFv, VHH), (2) a framework for tumor antigen- Expectations conventional dosing. proprietary human anti- anchored CD137 bispecifics • Framework for Risk- These platforms are GPCR antibody phage • PD-L1 x CD137 offers the Based Quality System currently evaluated in display library focused on ability to also simultaneously • Examples of Lifecycle the clinic. this validated target class, block a checkpoint in addition matrix • We will compare these and (3) a Twist Antibody to CD137 costimulation platforms and the Optimization (TAO) • TAA x CD137 bispecific Dawn Wofford, Regulatory challenges and platform for antibody molecules enhance the anti- Affairs Director, Cytovance opportunities of each affinity and developability tumor activity of CD3-based Biologics (CONFIRMED) platform will be optimization bispecific DART molecules and highlighted Fc-optimized therapeutic Aaron Sato, Chief Scientific mAbs Javier Chaparro-Riggers, Officer, Twist Biopharma, a Executive Director, Pfizer division of Twist Bioscience Alexey Berezhnoy, Scientist II, (CONFIRMED) (CONFIRMED) MacroGenics (CONFIRMED) 2:40pm Reducing immunogenicity risk Avidity driven bifunctionality Targeted and conditional Effective CMC strategies for Development of NM21- by abrogating pre-existing • The targeting of ubiquitously bispecific for the treatment of downstream process 1480 a trispecific anti-PD- antibody binding to protein expressed antigens requires a fibrosis development and L1x4-1BBxhSA antibody therapeutics selective tissue binding manufacturing under an fragment accelerated timeline

• Protein therapeutics, strategy to limit drug • Targeted and conditional • Future CMC • NM21-1480 is a novel engineered molecules in engagement to only the target bispecifics: Local perspectives for mAb trispecific antibody particular, bear an inherent tissue accumulation and activation developability from fragment fusion protein immunogenicity risk with • Bispecific antibody formats of pro-drugs. Improving early to late stage directed against PD-L1 potential impact on safety provide the opportunity to therapeutic potential of bio- clinical trials and 4-1BB and efficacy develop unique tissue therapeutics by increasing • A Technical Case Study • The molecule is • Pre-existing anti-drug targeting strategies drug concentrations to target • What was the problem? designed to block PD- antibodies (PE-ADA) in • We have developed tissues and limiting systemic • What was technical 1/PD-L1 signalling and addition to treatment- bispecifics that demonstrate exposure resolution? elicit an intratumorally induced ADAs have been target tissue selective binding • Antibody engineering, • What was the outcome restricted CD8+ T cell recently recognized as a using detuned affinities that screening and in vivo study (with Measure – impact activation, promising a drug development bind at the limit of avidity using a preclinical model of on product quality, favorable benefit-to-risk challenge fibrosis will be presented Operational efficiency profile • Origins, clinical impact, and Bellos Hadjivassiliou, Senior showing the potential of this etc.)? • In vivo experiments detection of PE-ADA, as Scientist, Bristol-Myers Squibb technology have shown efficacy well as protein engineering (CONFIRMED) • Novel technology for new Richard Ding, Director of and tolerability and the strategies to abrogate PE- targets and biomarkers Downstream Purification molecule is expected to ADA binding, will be discovery and Manufacturing, enter clinical testing in discussed AnaptysBio (CONFIRMED) Q3/2020 Ivan Mascanfroni, Senior Scientist Petra Verdino, Principal III, Immunology Biologics, Abbvie Sebastian Meyer, COO, Scientist, Eli Lilly and Company Bioresearch Centre (CONFIRMED) Numab Innovation AG (CONFIRMED) (CONFIRMED) 3:00pm Drug conjugates based on Title and speaker TBA Structure based design of Early consideration in the Tumor-targeted Immune- engineered affibody molecules vaccines and therapeutics against design, expression and stimulating antibody • Affibody molecules are Influenza virus purification of therapeutic conjugates small engineered • Broadly neutralizing humanized antibody • Immune-stimulating alternative scaffold affinity antibodies to influenza fragments for a successful antibody conjugates proteins, which may be hemagglutinin have defined pharmaceutical (ISACs) are tumor- designed to bind to major sites of vulnerability development targeting antibodies receptors over-expressed • More universal vaccines are • Humanization of conjugated with on different tumor cells being designed based on the antibody fragments: Do powerful innate • Affibody molecules can be conserved neutralizing it with the end in mind immune stimulants site specifically loaded with epitopes • Early assessment of • ISACs are capable of the cytotoxic drug DM1, • Multidomain antibodies, microbial and invoking potent myeloid creating homogenous small proteins, peptides and mammalian host cells is cell activation and the small molecules have been production of pro-

conjugates with a desired designed as therapeutic advantageous for inflammatory cytokines drug-to-affibody ratio candidates successful USP that favor a productive • HER2-specific affibody drug • Protein L is a gold anti-tumor immune conjugates slow tumor Ian Wilson, Hansen Professor of standard for successful response growth and increases Structural Biology, Skaggs DSP but requires special • ISACs are active in survival in an animal model Institute for Chemical Biology, The tailoring during the preclinical in vivo of ovarian cancer Scripps Research Institute antibody humanization models of cancer and (CONFIRMED) process are highly efficacious by Torbjörn Gräslund, Professor, enhancing ADCP, Medical Protein Technology, Philippe Billiald, Full promoting antigen KTH Royal Institute of Professor, University Paris- presentation, Technology (CONFIRMED) Saclay, Scientific Advisor and immunological memory, Co-Founder, Acticor Biotech and epitope spreading (CONFIRMED) David Dornan, Senior Vice President and Head of Research, Bolt Biotherapeutics (CONFIRMED) 3:20pm Afternoon networking break Payers panel Novel indications for therapeutic CMC, developability and Antibodies for immunotherapy Chaired by Jeffrey Froude, Major, Stm, antibodies manufacturability Chaired by: C. Russell Cruz, Assistant Vaccines and Therapeutics Division, Chaired by: Ivan Mascanfroni, Senior Chaired by: Rajesh Krishnan, Senior Vice Professor, Children’s National Hospital Defence Threat Reduction Agency Scientist III, Immunology Biologics, President, CMC and Manufacturing (CONFIRMED) (CONFIRMED) Abbvie Bioresearch Centre Operations, Oncternal Therapeutics (CONFIRMED) (CONFIRMED) 4:00pm Payers panel Human antibody responses to influenza Uncovering undesirable properties of • This study demonstrates that NEO- in context mAb clones from overexpression- 201 has several mechanisms of Moderator: Jeffrey Froude, Major, Stm, • Influenza virus infection and induced cell phenotypes by using the action. NEO-201 is able to mediate Vaccines and Therapeutics Division, vaccination in various contexts ER as a physiological test tube both ADCC and CDC. Defence Threat Reduction Agency drives unique antibody responses • Condensation-prone IgGs can • In addition, NEO-201 can block the that inform on antibody-mediated induce at least three different types interaction between tumor cell Panellists: control of the virus of prominent intracellular inclusion CEACAM5 and NK cell CEACAM1 to Amy Jenkins, Programme Manager, • The antibody repertoire induced is bodies in the ER during mAb reverse CEACAM1-dependent DARPA (CONFIRMED) driven by immune history overexpression in mammalian cells inhibition of NK cytotoxicity. David Boucher, Chief, Antivirals & • Overcoming biases in B • Apparent correlations between • These results suggest that NEO-201 Antitoxins, Biomedical Advanced cell/antibody responses is a major protein condensation events in the may potentially reverse CEACAM1- ER and solution behaviours in vitro

Research and Development Authority obstacle to improved influenza can be leveraged to identify mAb dependent immunosuppression of (BARDA) (CONFIRMED) vaccination and therapy clones that are not suitable for NK cells in patients whose tumors Rachel Overman, Deputy Join Product high-level production and high express the NEO-201-reactive Manager, BIO 2, JPM CBRN Medical Patrick Wilson, Professor, Department concentration liquid formulation variant of CEACAM5. (CONFIRMED) of Medicine/Rheumatology, The • This cell phenotype screening assay • NEO-201 can also target and Helen Schiltz, Program Officer, University of Chicago (CONFIRMED) enables a pre-emptive elimination eliminate human Therapeutics Development, National of unfavourable mAb clones from a immunosuppressive regulatory T Institute of Health, NIAID (CONFIRMED) large panel of lead candidates at an cells (Tregs). early stage of antibody discovery • Additional mechanisms are under program investigation Al Tsang, Chief Scientific Officer, Haruki Hasegawa, Principal Scientist, Precision Biologics (CONFIRMED) Department of Therapeutic Discovery, Amgen (CONFIRMED) 4:20pm Tissue-based B-cell subsets and clonal Developability assessment to select Bispecific antibodies for guided networks well-behaved mAbs for clinical inhibition of CD47 • Tissue-based B cell subsets development • CD47-SIRPa axis, a phagocytosis • Clonal networks of influenza- • Monoclonal antibodies are often checkpoint, is a promising target for binding B cells administered as subcutaneous cancer immunotherapy. Yet, • How influenza-binding B cells injections where favorable solution therapeutic inhibition of CD47 on partition into different B-cell behavior is necessary to enable tumor cells is hindered by subsets highly concentrated mAb ubiquitous expression of the target • Implications for immunologic formulations in healthy tissue memory and vaccine design • Prior to clinical development well- • Undesirable on-target/off-tumor behaved mAbs must be selected for effects typically observed with Nina Prak, Professor of Pathology and over those that pose challenges to CD47 blocking monoclonal Laboratory Medicine, Perelman School achieving differentiated dosage antibodies can be largely mitigated of Medicine, University of Pennsylvania forms with a bispecific antibody, which (CONFIRMED) • Developability assessments enable guided (i.e., selective) incorporating well-characterized inhibition of CD47 on cancer cells predictive methods enable the • Such CD47-blocking bispecific selection of well-behaved mAbs antibodies show potent anti-tumor activity associated with favorable Michaela Lantz, Scientist, Sanofi pharmacokinetics and safety (CONFIRMED) profiles Mechanisms of action of a neoantigen- targeting antibody NEO-201

Krzysztof Masternak, Head of Discovery, Light Chain Bioscience – a brand of Novimmune SA (CONFIRMED) 4:40pm High-throughput single-cell approaches Efficient and scalable membrane A novel platform for T-cell redirection to determine antibody genes and devices for biologics purification that elicits efficient tumour lysis with functional features • New designs for membrane minimal cytokine release in multiple • High-throughput single cell separation devices tumour types heavy:light sequencing enables • Fast, scalable, high-resolution • Discovery of novel CD3 binding natively paired antibody yeast purification antibodies display • Comparison with currently used • Unique functional activity based on • Immortalized human yeast display devices novel epitope and affinity libraries are screened to identify • Biologics purification case studies • T-cell redirecting bispecific antigen, epitope, and affinity including mAbs purification antibodies that efficiently lyse • Several case studies including HIV tumors with low levels of cytokine naturally infected and ZIKV Raja Ghosh, Professor, Chemical release convalescent patients Engineering, McMaster University • TNB-383B lead molecule currently • Comprehensive mutational analysis (CONFIRMED) in phase 1 clinical development reveals unique pathways for antibody improvement Nathan Trinklein, Chief Technology Officer, Teneobio (CONFIRMED) Brandon Dekosky, Assistant Professor, The University of Kansas (CONFIRMED) 5:00pm Title TBA Optimisation of single cell cloning and Mucin (MUC)16-directed CHO cell characterisation during immunotherapeutic strategies for Tina Kiffer Bay, Research Investigator II, biologics production ovarian cancer GNF (CONFIRMED) • Improvements in single cell cloning • Immunotherapy has not been as recovery effective in ovarian cancer • Integration of platform production compared with other solid tumor processes with clone screening cancers such as melanoma methods • Selection of an appropriate tumor- • Characterization of cellular restricted antigen and the presence trafficking events induced during of a highly immunosuppressive batch and perfusion production tumor microenvironment have limited therapeutic efficacy in this David Busch, Senior Scientist, Merck disease (CONFIRMED) • One approach to this problem lies in chimeric antigen receptor (CAR)

T-cells which do not require T-cell receptor (TCR)- based recognition for efficacy • Another approach is the use of bispecific T-cell engagers, which could potentially induce antigen spreading beyond the targeted tumor-associated antigen

Olapado Yeku, Assistant Clinical Attending, Massachusetts General Hospital (CONFIRMED) 5:20pm Networking drinks and poster presentation session

Day 3 – Wednesday March 4th 2020 8:30am Registration opens New technology in screening and Immunogenicity and QA/QC CMC, developability and manufacturability Research hub analytics Chaired by: Sebastian Stolzenberg, Chaired by: Jon Strauss, Director of CMC, Chaired by: Gregory Weiss, PostDoc Project Leader, Free Calibr, a division of Scripps Research Professor, University of California University of Berlin (CONFIRMED) (CONFIRMED) Irvine (CONFIRMED) 9:00am A reagent-independent, targeted MAb immunogenicity 101 Understanding the factors that affect cell Personalized T cell recruiting bispecific 2D-LC-MS/MS method enabling • What are the factors that line selection autoantibodies for treating cancer quantification of monoclonal contribute to immunogenicity? • Differences in expression between • Strategy to overcome tumor antigen antibodies and biomarkers in the • Can immunogenicity be high and low productivity clones were loss and heterogeneity pg/mL range in serum predicted? analysed using proteomics, • Tumor-specific targeting for tumors • Mass spectrometry has emerged • Can immunogenicity be transcriptomics, phosphoproteomics without validated antigens as a powerful analytical tool for mitigated? and DNA methylation analysis • Antibody conjugation method for assessment of pharmacokinetics • Differential transcription factor site-specific, covalent modification and biomarkers during the drug Jack Ragheb, Senior Medical Fellow, binding correlates with increased with nearly any antibody development process Immunology, Eli Lilly & Company productivity • T cell recruiting bispecific • Compared with ligand binding (CONFIRMED) • Cell machinery responds to increased autoantibodies using our production assays, a major limitation of gene expression by upregulating method function as expected in vitro mass spectrometry-based assays energetic and protein processing and in vivo is their lower sensitivity pathways • To address the sensitivity issue, Fabiana Zappala, PhD Student, University we have developed a reagent- Susan Sharfstein, Professor of of Pennsylvania (CONFIRMED) independent, targeted 2D-LC- Nanobioscience, College of Nanoscale MS/MS method which enabled Science and Engineering, SUNY 100X improvement in assay Polytechnic Institute (CONFIRMED) sensitivity compared with conventional LC-MS/MS • A major advantage of this method over ligand binding assays is that it is independent of high quality capture or detection reagent

Jintang He, Scientist, Genentech (CONFIRMED)

9:20am The pathway to the analytical/QC Immunogenicity of bioproducts: Title TBA Dissecting virus-antibody interactions laboratory of the future - A digital cellular models to evaluate the with a vaccinia virus-based display world awaits impact of therapeutic antibody Tawnya Flick, Principal Scientist, Amgen platform • Digitalization of the laboratory aggregates (CONFIRMED) • We display full-length hantavirus will transform the way we • Optimization of in vitro methods glycoproteins on the surface of develop, transfer, execute and to evaluate the potential of vaccinia virus particles analyze assays and their data aggregated therapeutic • We generate vaccinia-displayed • Use of automation, cognitive antibodies to induce early libraries of mutant glycoproteins computing and artificial adaptive immune responses that using deep mutational scanning intelligence allows for speed in could drive ADA development • The libraries can be used to define assay screening, assay • Predictive assays that can the molecular basis of neutralizing development and improves data monitor DC maturation, in order antibodies reliability to determine whether different • Virtual reality improves in assay antibody aggregate types have Ethan Laudermilch, Post-Doc, Albert design, training and analytical direct DC stimulatory capabilities Einstein College of Medicine technology transfer • Original co-culture model to (CONFIRMED) • Paperless laboratories reduce assess the potential of oligomeric human error and allow analysts and subvisible antibody to focus on science and big data aggregates stimulated DC to drive analytics drives assay data T lymphocyte cells activation and understanding polarization

Anthony Mire-Sluis, Head of Global Isabelle Turbica, Associate Professor, Quality, AstraZeneca (CONFIRMED) Paris-Sud University (CONFIRMED) 9:40am Collision induced unfolding: Rapid Biologics and its immunogenicity in Overcome liquid-liquid phase separation Identification and characterization of stability analyses for monoclonal the early clinical development (LLPS) caused manufacturing challenges KRAS G12V-specific CD4 T cells from the antibodies and biosimilars • Biologics and the immunogenicity for a therapeutic monoclonal antibody blood of a pancreatic cancer patient • Ion mobility-mass spectrometry • The impact on the efficacy and • LLPS caused problems for the • We have developed a novel HLA- (IM-MS) is a versatile tool for safety downstream manufacturability of a agnostic approach to neoantigen quickly assessing the higher- • How to detect and manage therapeutic mAb. Process parameter identification which combines order structure (HOS) of mAb immunogenicity during the optimization partially mitigated the genomic sequencing, bioinformatic samples development LLPS, however limitations remained analysis, and functional assays • Collision induced unfolding (CIU) for large-scale manufacturing • We identified eleven dominant CD4 T is a gas-phase analogue of Joan Shen, Head of Research and • We carried out a systematic clones from the blood of a pancreatic calorimetry measurements Development, I-Mab Biopharma investigation to gain mechanistic cancer patient and confirmed routinely taken to assess protein (CONFIRMED) insight into LLPS behavior and specificity, restriction, minimal therapeutics, capable of rapid developed mitigation strategies epitopes, and avidity

(~5 sec / sample) mAb analysis • Protein engineering disrupting inter- • These KRAS G12V-specific CD4 TCRs using small amounts of molecule electrostatic interactions could be of therapeutic value to unpurified samples resulted in LLPS free mAb with patients with the same driver • CIU can rapidly differentiate improved developability mutation and HLA haplotype mAb samples based on HOS differences caused by sequence, Qun Du, Scientist I, AstraZeneca Martin Naradikian, Postdoctoral Fellow, stress, disulfide bonding pattern, (CONFIRMED) La Jolla Institute for Immunology glycosylation, and conjugation (CONFIRMED) state (for antibody-drug conjugates). • CIU screening can differentiate biosimilars from innovator mAbs, enabled by multi-state classifiers built upon machine learning algorithms developed in the Ruotolo lab.

Brandon Ruotolo, Professor, Chemistry, University of Michigan (CONFIRMED) 10:00am Epitope-targeted antibody screening Molecular Insights into key Concentration does matter for analytical Inhibition of filovirus infection by host- • A new approach to selection of mechanistic steps of an adaptive method transfer for bispecifics targeted Trojan horse bispecific antibodies binding to the immune response • Review the driver for requiring the antibodies targeted epitope in the antigen. • Computational methods: need for transfer of product specific • Antibodies can inhibit filovirus entry • By one- or two-round of panning Molecular dynamics simulations, methods and the timeline by blocking viral surface glycoprotein against phage display libraries, Markov State Modelling, a deep • Review the challenges that occurred and host cell receptor engagement. hits binding to the target learning during method transfer and the work • Lysosomal targeting tags increase epitope can be enriched and • Allosteric couplings found in arounds uptake of antibodies into cells identified simulated Peptide-MHCII • Recommendations for improvements • Engineered anti-filoviral antibodies • Hits identified by this approach complexes for CMC management of method with lysosomal targeting tags inhibit are not biased to their initial • Protein immunogenicity transfer filovirus entry affinities and retain high level of prediction Ariel Wirchnianski, PhD Candidate, Albert sequence diversity. Jon Strauss, Director of CMC, Calibr, a Einstein College of Medicine Sebastian Stolzenberg, PostDoc division of Scripps Research (CONFIRMED) Feng Wang, Associate Director, Project Leader, Free University of (CONFIRMED) Principal Investigator, Institute of Berlin (CONFIRMED)

Biophysics, Chinese Academy of Sciences (CONFIRMED) 10:20am Generating pairs of recombinant Title and speaker TBA Development of the filamentous fungus Comprehensive analysis of neutralizing affinity reagents for sandwich Myceliophthora thermophila C1 into a antibodies raised against the yellow fever assays through MegaSTAR next-generation therapeutic protein virus vaccine • Millions of pair-wise production system • First comprehensive analysis of combinations created and • Myceliophthora thermophila C1 is a antibody response to yellow fever tested in a single tube highly potent protein production host vaccine • Inherently biased towards exploited for industrial enzyme • Emergence of highly potent identification of non-overlapping production. We aim to utilize its vast neutralizing antibodies after binding pairs production potential in production of vaccination over time • Extensive epitope coverage biologics • Insights into the capacity of the • Suitable for generating • The host protease activity limits vaccine to protect against the monospecific reagents to production of therapeutic and vaccine emerging yellow fever virus strain in members of protein families proteins. We have characterized them Brazil that are challenging targets due and generated multiple protease to high sequence identity gene deficient production strains Denise Haslwanter, Research Fellow, • Superb production levels have been Albert Einstein College of Medicine Brian Kay, Professor, Department of obtained, e.g. up to 22 g/l of Mabs, (CONFIRMED) Biological Sciences, LAS up to 13 g/l of Fc-fusion proteins in a Distinguished Professor & University 6-7 day bioprocess. Many difficult-to- Scholar, University of Illinois at express proteins have been produced Chicago (CONFIRMED) successfully • We work to humanize the C1 glycosylation machinery by deleting native sugar transferases and expressing components of animal glycosylation pathways in the fungus

Markku Saloheimo, Senior Principal Scientist, VTT Technical Research Centre of Finland (CONFIRMED) 10:40am Morning networking break New technology in screening and analytics Computational discovery and development Chaired by: Gregory Weiss, Professor, University of California Irvine Chaired by: Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi (CONFIRMED) Genzyme (CONFIRMED) 11:15am Single-molecule detection of proteins using membrane protein engineering Using big data and computations to guide the design of better antibodies

• A generic strategy for single-molecule detection of protein biomarkers in • We present a discovery and design platform that is based on a combination of a complex biofluid will be discussed computational and biochemical tools. • We have manufactured a selective sensor is like a fishing rod with three • We show how it is used to design and produce parts: a tethered protein receptor in the form of a hook, a hexapeptide • Antibodies that surgically bind to functional epitopes, thus leading to the desired tether, which is similar to a short, flexible line, and a signal transducer, mechanism of action. functioning like an angling rod • Multibodies: Antibodies that maintain the natural IgG format but can bind two • The transducer forms a membrane protein nanopore that facilitates a different epitopes on two different targets. uniform electrical current • Sub nanomolar affinity binding • When a free protein ligand in solution is reversibly bound by the tethered • Good developability profile protein receptor, transient capture and release events are measured as • We will show experimental results from biological studies of our antibodies current deflections between two substates of the nanopore • Our highly specific sensor could be extended to emerging areas of Yanay Ofran, Founder and Chief Executive Officer, Biolojic Design (CONFIRMED) molecular diagnostics or might be adapted to develop tools in high- throughput protein profiling and drug discovery

Liviu Movileanu, Professor, Department of Physics, Syracuse University (CONFIRMED) 11:35am Higher order structural analysis of protein therapeutics using mass Title TBA spectrometry • Reliable, structurally informative, and rapid higher-order structural Senior representative, Schrödinger (CONFIRMED) analysis of protein therapeutics is important for ensuring their safety and efficacy • A method based on covalent labeling and mass spectrometry has been developed to identify protein aggregation sites and specific protein regions that undergo subtle structural changes upon mishandling or stress • Covalent labeling with mass spectrometry can provide residue specific structural information under a wide variety of conditions much more rapidly than existing high resolution techniques, such as NMR • When used together with hydrogen/deuterium exchange, covalent labeling mass spectrometry can provide unprecedented structural information for protein therapeutics

Richard Vachet, Department Head, Professor in Chemistry, University of Massachusetts Amherst (CONFIRMED) 11:55am Higher order structure and molecular mechanism of action analysis for Machine learning enables accurate prediction of deamidation probability and rate accelerated drug design

• Will introduce mass spectrometry and nuclear magnetic resonance • Deamidation is a major pathway of protein degradation and has been shown to technologies for characterizing higher order structure and molecular negatively affect both in vitro stability and in vivo biological function of diverse mechanism of action classes of proteins • 'Real world' examples of HOS and MoA accelerated biopharmaceuticals • During protein therapeutics development, deamidation liabilities that are development in cancer, neurodegenerative disease and vaccine overlooked necessitate expensive and time-consuming remediation strategies, development sometimes leading to termination of the project • Will introduce concept of 'dynamics-guided drug design' • We applied machine learning to create computational models for antibody asparagine deamidation with nearly 5% increased accuracy over the best currently Derek Wilson, Director, Wilson Lab, York University (CONFIRMED) available models. Surprisingly, our model also paces or outperforms advanced and conventional models on non-antibody proteins • In addition to deamidation probability, we are able to accurately predict deamidation rate, a capability with no peer in current models

Jared Delmar, Scientist I, AstraZeneca (CONFIRMED) 12:05pm Characterization of mAb and ADC charge variants Title TBA

Romesh Rao, Research Associate III, Seattle Genetics (CONFIRMED) Sandeep Kumar, Senior Research Fellow, Biotherapeutics, Boehringer Ingelheim (CONFIRMED) 12:25pm Using mechanical energy to drive protein purification, folding, and antibody Homology model guided humanization of a mouse antibody against Leukemia (B-CLL) discovery • We have generated a humanized antibody that specifically targets unique • A vortex fluidic device (VFD) inputs mechanical energy into solutions to population of leukemic cells that are over expressed in certain B-CLL patients drive chemical transformations — including protein folding and • Homology model-based humanization designs were successful over sequence- purification based approaches, both case studies will be presented • The VFD offers a simple, efficient, and rapid approach to immobilize and • Affinity maturation was achieved in spite of unknown epitope information purify proteins in a VFD reactor • Recent results applying this system to molecular evolution and selections Vinodh Kurella, Senior Scientist II, Antibody Discovery and Designs, Voyager with antibody fragment libraries and other applications will be presented Therapeutics (CONFIRMED)

Gregory Weiss, Professor, University of California Irvine (CONFIRMED) 12:45pm Networking lunch Americas Antibody Congress – Closing plenary Chaired by: Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme (CONFIRMED) 1:45pm A regulator’s perspective on trends and challenges in the development of monoclonal antibodies • Current trends in mAb submissions • FDA’s current thinking on critical quality attributes related to safety, efficacy, pharmacokinetics and immunogenicity • Questions to answer to help the development and regulation of future mAbs

Marjorie Shapiro, Supervisory Biologics Office of Biotechnology Products, CDER, FDA (CONFIRMED) 2:05pm Antibody discovery platforms- innovations and advancements • Snapshots of the different platforms- traditional to contemporary • Paradigm changing advancements in each • What’s new and how does it impact speed and cost of antibody discovery • Future trajectories

Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme (CONFIRMED) 2:25pm Title and speaker TBA

2:45pm Chair’s closing remarks 2:55pm Closing remarks from Terrapinn 3:00pm End of conference

Presents

World Immunotherapy Congress USA 2019

Advisory board David Sourdive, Co-founder, Executive Vice President - Technical Operations, Cellectis Stephen Schoenberger, Professor, La Jolla Institute for Immunology Roy Baynes, Senior Vice President and Head Global Clinical Development, Chief Medical Officer, Merck

Speakers Roy Baynes, Senior Vice President and Head Global Clinical David Fontana, Head Strategic Alliance & JCAR017 Program Lead, Juno Development, Chief Medical Officer, Merck Therapeutics Andrew Allen, President & Chief Executive Officer, Gritstone Pascal Touchon, President and CEO, Atara Biotherapeutics Therapeutics Alan K. Smith, Executive Vice President, Technical Operations, Ira Mellman, Vice President, Cancer Immunology, Genentech Bellicum Bob Valamehr, Chief Development Officer, Fate Therapeutics Gary Starling, Associate Vice President, Merck Prentice Curry, Senior Vice President Quality and Compliance, Kite Douglas Jolly, Executive Vice President, Research and Pharmaceutical Pharma Development, Tocagen Rich Murray, CEO, Jounce Therapeutics Christine Brown, Associate Research Professor, City of Hope Shahram Salek-Ardakani, Senior Director, Cancer Immunology, Pfizer

Jeffrey Miller, Professor of Medicine, University of Minnesota, Deputy Kelly Coulbourne, Associate Director, Clinical Trial Data Registries, Director, University of Minnesota Masonic Comprehensive Cancer Allergan Center Brian Champion, CSO, PsiOxus Therapeutics Olapado Yeku, Assistant Clinical Attending, Massachusetts General Dan Kaufman, Professor of Medicine, Director of Cell Therapy, UCSD Hospital Eric Halioua, President and Chief Executive Officer, PDC*line Pharma Michael Yellin, VP, Clinical Science, Celldex Therapeutics Christopher Thanos, CEO, Actym Therapeutics Larry Lum, Professor, Director of Cellular Therapy, Scientific Director Jonathan Pachter, CSO, Verastem Oncology of Bone Marrow Transplant, University of Virginia Christophe Quéva, CSO, Oncorus Frédéric Triebel, Chief Scientific Officer, Chief Medical Officer, Mohamed Ladha, Vice President and Head, Commercial, Tocagen Immutep Robert Wild, Chief Scientific Officer, Dracen pharmaceuticals James Legg, SVP Research and Development, Crescendo Biologics Kanti Thirumoorthy, Executive Director, Operations Team Lead, Stephen Schoenberger, Professor, La Jolla Institute for Immunology Process Development, Kite Pharma Ezra Cohen, Associate Director, U.C. San Diego Moores Cancer Center Caroline Breitbach, VP R&D Programs and Strategy, Turnstone Nicolas Poirier, Chief Scientific Officer, OSE Immunotherapeutics Biologics Denise Steckel, Head, Clinical Collaborations Management, Genentech Joanne Tan, Research Fellow/Associate Director, Arcus Biosciences Jay Mandrekar, Professor of Biostatistics and Neurology, Mayo Clinic Theodore Roth, Research Fellow, UCSF Saso Cemerski, Senior Director of Translational Immunology, Cue C. Russell Cruz, Assistant Professor, Children’s National Hospital Biopharma David Dornan, Senior Vice President of Research, Bolt Biotherapeutics Sari Pesonen, VP, Scientific and Clinical Development, Co-Founder, Sebastian Meyer, COO, Numab Innovation AG Valo Therapeutics Javier Chaparro-Riggers, Executive Director, Pfizer Laurent Humeau, CSO, EVP of Research, Engineering and Clinical Greg Babcock, Vice President, Research, Visterra Inc Developments, Inovio Pharmaceuticals Werner Meier, CSO, Revitope Oncology Kate Broderick, Vice President, Inovio Pharmaceuticals Bruce Keyt, CSO, IGM Biosciences Giedre Krenciute Assistant Member, St. Jude Children’s Research Karsten Sauer, Vice President, Immunology, Torque Therapeutics Hospital Robert Coffin, CEO, Replimmune Steven Feldman, Director of Manufacturing and Process Development, Miguel Garcia-Guzman, Chief Scientific Officer, Rakuten Medical Stanford Center for Cell Therapy John Bell, Professor of Medicine, Ottawa Health Research Institute Jim Heath, President and Professor, Institute for Systems Biology Farshad Gurakhoo, CSO, GeoVax Nate Root, Associate Director, Clinical Disclosure & Transparency, Sharareh (Serri) Gholamin, Researcher, Caltech Ionis Pharmaceuticals Nathan Trinlein, Chief Technology Officer, Teneobio Bill Monteith, Executive Vice President, Technical Operations, Cellectis Cliona Rooney, Professor, Department of Pediatrics, Section of Keri Schadler, Assistant Professor, MD Anderson Cancer Center Hematology-Oncology, Baylor College of Medicine Christina Yi, Chief Operations Officer, Dendreon Care - Blood and Marrow Transplant Unit Loui Madakamutil, SVP, Head of Biology and Preclinical Development, Anne Cunniffe Marcy, Clinical Research Coordinator, Stanford Nektar Therapeutics University School of Medicine - Cancer Clinical Trials Office Steven Jonas, Researcher, UCLA Scott Carmer, CEO, NexImmune Justin Eyquem, Principal Investigator - Parker Fellow, UCSF Maksim Mamonkin, Assistant Professor, Baylor College of Medicine RJ Tesi, CEO/CMO, InMune Bio

Mark Lowdell, CSO, InMune Bio Sandhya Girish, Senior Director, Global head Oncology, Genentech Linda Liu, SVP, Research, NextCure Barbara Hickingbottom, Vice President, Clinical Development, Xencor Darya Alizadeh, Assistant Research Professor, City of Hope Kefeng (Kevin) Hua, Senior Manager, AI/Machine Learning Niranjan Y. Sardesai, Co-Founder, President and CEO, Geneos Development, Bayer Therapeutics Alvin Luk, Senior Vice President & Chief Medical Officer, Shanghai Agnete Fredriksen, Co-Founder, President and CSO, Vaccibody Henlius Biotech Deepak Khatry, Science Associate Director, Oncology Biometrics, Su Xiao, CEO, Neuropth AstraZeneca Rajesh Krishnan, Senior Vice President, Process Development and Marit van Buuren, Lab Head, Scientist II, Immunology, Neon Manufacturing, Oncternal Therapeutics Therapeutics Tam Soden, Senior Director, Kite Pharma Lobelia Samavati, Associate Professor of Molecular Medicine and Rajita Pappu, Senior Scientist, Genentech Genetics, Center for Molecular Medicine and genetics Fabiana Zappala, PhD Student, University of Pennsylvania David Reardon, Clinical Director, Center for Neuro-Oncology, Dana- Shannon Turley, Staff Scientist and Group Leader in Cancer Farber Cancer Institute Immunology Discovery, Genentech Philip Arlen, President & CEO, Precision Biologics Angelica Loskog, CEO, Lokon Pharma Shawn Fahl, Director, Flow Cytometry Services, Discovery Life Alfonso Quintas, Chief Medical Officer, TCR2 Therapeutics Sciences Ethan Laudermilch, Post-Doc, Albert Einstein College of Medicine Vassiliki Papadimitrakopoulou, Professor of Medicine in the Martin Naradikian, Postdoc, La Jolla Institute for Immunology Department of Thoracic/Head and Neck Medical Oncology, MD Denise Haslwanter, Research Fellow, Albert Einstein College of Anderson Cancer Center Medicine Joann Peters, Vice President Clinical Operations, Geneos Therapeutics Ariel Wirchnianski, PhD Candidate, Albert Einstein College of Cathy Carfagno, Associate Director, Merck Medicine Jessica Baker Flechtner, CSO, Genocea John M. Burke, Co-Founder, President and CEO, Applied Biomath Christina Annunziata, Head, Translational Genomics Section, NIH Hanspeter Gerber, SVP & CSO, 3T Biosciences Sujith Joseph, Senior Scientist, Baylor College of Medicine Simon Lacey, Director, The Center for Cellular Immunotherapies, Corey Carter, CEO, EpicentRx INC University of Pennsylvania AJ Joshi, SVP, Chief Medical Officer, Atara Biotherapeutics Roman Yelensky, EVP & Chief Technology Officer, Gritstone Oncology Al Tsang, CSO, Precision Biologics Kathryn Austgen, Associate Director, BlueRock Therapeutics Krzysztof Masternak, Head of Discovery, Light Chain Bioscience – a John M. Burke, Co-Founder, President and CEO, Applied Biomath brand of Novimmune SA Steve Thorne, Chief Scientific Officer, Western Oncolytics Brent Rice, Vice President, Global Market Access, Autolus Shiaw-Yih Lin, Professor and Deputy Chair, MD Anderson Amrik Basran, Chief Scientific Officer, Avacta Senior Representative, ACROBiosystems Marina Udier, CEO, Nouscon Michael J. LaBarre, Senior Vice President, Chief Technology Officer, Christopher (CJ) Barnum, Director of Neuroscience and Translational Halozyme Medicine, INmune Bio Lelisa Gemta, Associate Scientist, Regeneron Pharmaceuticals Matteo Levisetti, Chief Development Officer, DNAtrix Workshop hosts: Wenfeng Xu, Vice President of Research, Hengenix

Julie Gerberding, Executive Vice President, Communications, Global Policy, and Population Health & Chief Patient Officer, Merck Eve Bukowski, Vice President, Patient Advocacy, Education & Outreach, California Life Sciences Association (CLSA) Brenda Hann, Director, Clinical Trials Operations, Stanford Medicine Janet McDowell, Clinical Research Manager, Stanford University School of Medicine - Cancer Clinical Trials Office Theresa Latchford, Oncology Clinical Nurse Specialist, Stanford Health Amrit Takhar, GP Partner and Clinical Lead, Wansford surgery – NHS

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Day 1 – Monday March 2nd 2020 7:30am Registration opens Opening keynotes 9:00am Opening remarks from Terrapinn 9:05am Chair’s opening remarks 9:10am Mechanistic basis of cancer immunotherapy: checkpoints@10 • Checkpoint inhibition has revolutionized both cancer biology and cancer care. • However, only a minority of patients receive substantial benefit, and no new immunomodulators have been approved outside of the PD-l1/PD-1 axis. Why? • Progress can be made, but will require a deeper and more accurate understanding of the mechanisms of tumor immunity, even our understanding of how checkpoint inhibitors work may be fundamentally flawed Ira Melmann, Vice President, Cancer Immunology, Genentech (CONFIRMED) 9:35am Translational Immunotherapy • Translating preclinical science to biology in the clinic • The critical role of mechanism specific pharmacodynamic and predictive biomarkers • Can we achieve a precision medicine state for immunotherapy? Rich Murray, CEO, Jounce Therapeutics (CONFIRMED) 10:00am NK cell Therapy: individualized products to off-the-shelf strategies • Understand the biologic concept of adaptive NK cells with properties of immune memory • Understand how the CD16 activating receptor can be repurposed to make NK cells antigen specific • Understand concepts of off-the-shelf induced pluripotent derived NK cells Jeffrey Miller, Professor of Medicine, Division of Hematology, Oncology and Transplantation, University of Minnesota (CONFIRMED) 10:25am Morning networking break 11:30am Plenary roundtable session 15 senior level tables hosted by thought leaders on key challenges and opportunities in antibody drug discovery and development. Participants are invited to join the group discussions on a topic of importance to them. The round table session will have two rotations, each lasting 35 minutes. TABLE 1 TABLE 2 TABLE 3 Novel modalities in immunotherapy Product management models Title TBA Gary Starling, Associate Vice President, Merck Kanti Thirumoorthy, Executive Director, RJ Tesi, CEO/CMO, InMune Bio (CONFIRMED) (CONFIRMED) Operations Team Lead, Process Development, Kite Pharma (CONFIRMED) TABLE 4 TABLE 5 TABLE 6 Change management Current and future reimbursement challenges for Challenges facing bispecific antibodies for Cathy Carfagno, Associate Director, Merck CAR-T cell therapies immunotherapy (CONFIRMED) Brent Rice, Vice President, Global Market Access, Wenfeng Xu, Vice President of Research, Hengenix Autolus (CONFIRMED) (CONFIRMED)

TABLE 7 TABLE 8 TABLE 9 Immune checkpoints inhibitors in combination Evolving immuno-oncology landscape Roundtable available with targeted biosimilars Roy Baynes, Senior Vice President and Head Global Alvin Luk, Senior Vice President & Chief Medical Clinical Development, Chief Medical Officer, Merck Officer, Shanghai Henlius Biotech (CONFIRMED) (CONFIRMED) TABLE 13 TABLE 14 TABLE 15 Reserved for supporting partner. If you are interested in being Reserved for supporting partner. If you are interested in being Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at involved, please contact Derek Cavanagh at involved, please contact Derek Cavanagh at [email protected] or +44 (0)207 092 1297 [email protected] or +44 (0)207 092 1297 [email protected] or +44 (0)207 092 1297 12:40pm Networking lunch 12:45- WORKSHOP: Comparing strategies and challenges of bispecific antibody infusion 1:20pm • What is an ideal bispecific antibody for different approaches? • What's the pathophysiology of side effects related to different routes of delivery of bispecific antibody infusions? • What are the advantages and disadvantages of different approaches using bispecific antibodies? • What are the challenges preventing clinical effectiveness using the various platforms? Larry Lum, Professor, Director of Cellular Therapy, Scientific Director of Bone Marrow Transplant, University of Virginia (CONFIRMED) Cell Therapy Cancer Vaccines Tumor Microenvironment Solid Tumours Technology showcase

Chair: Bob Valamehr, Chief Chair: RJ Tesi, CEO/CMO, Development Officer, Fate InMune Bio Therapeutics 2:00pm Off-the-Shelf Cell-based Tumor neoantigens Immunologic effects of Promoting the survival of Reserved for supporting partner. If Cancer Immunotherapy: A delivered as solid tumor Duvelisib (PI3K-delta/gamma adoptively transferred tumor- you are interested in being involved, please contact Derek Cavanagh at Master Pluripotent Cell immunotherapeutics – what inhibitor) and Defactinib (FAK specific T-cells in the solid [email protected] or Platform for Mass are the early clinical data inhibitor) tumor environment +44 (0)207 092 1297 Production of Allogeneic telling us? • Effects of PI3K-delta and • T-cells require 3 signals for CAR-T and -NK cell Products • Mutation-derived PI3K-gamma inhibition on expansion and survival; • Using iPSCs to create neoantigens are key immune cells in the tumor lacking in the TME single cell derived tumor cell targets for microenvironment • Tumor-specific T-cells must engineered master cell the adaptive immune • Effects of FAK inhibition on survive multiple inhibitory lines with multiplexed system, but are rare, immunosuppressive cells signals functionality and their accurate and stromal density in the • Can T-cells be modified to • Creating renewable identification is tumor microenvironment thrive in this environment? master cell banks to challenging but • Efficacy in combination Cliona Rooney, Professor, achieve continuous necessary with checkpoint or co- Department of Pediatrics, stimulatory antibodies Section of Hematology-

production of engineered • Delivered within potent Jonathan Pachter, CSO, Oncology, Baylor College of NK and T cells vaccine vectors, Verastem Oncology Medicine (CONFIRMED) • Delivering cost effective, neoantigens may be (CONFIRMED) consistent and able to drive therapeutic homogenous cell immune responses therapeutics on demand • Clinical trials of and off-the-shelf neoantigen Bob Valamehr, Chief immunotherapies are Development Officer, Fate underway and early Therapeutics (CONFIRMED) data will be instructive as to how they may be best deployed in the solid tumor immunotherapy context Andrew Allen, President & Chief Executive Officer, Gritstone Therapeutics (CONFIRMED) 2:20pm Reserved for New class of Ag-specific Exercise as a novel method to Novel, cleaner targets for solid Reserved for supporting partner. If Acrosbiosystems cancer active improve tumor vascular tumor targeting with high potency you are interested in being involved, modalities please contact Derek Cavanagh at immunotherapies based on function [email protected] or • Conventional cell surface an off-the-shelf antigen • Moderate aerobic exercise +44 (0)207 092 1297 antigens with high expression presenting cell line remodels solid tumor across tumors are commonly (PDC*line) vasculature, improving expressed on normal tissues, • PDC*line is a new blood delivery and creating potential for on- potent and scalable decreasing blood flow target, off-tumor toxicities therapeutic cancer • In mice, exercise increases when targeted by high- vaccines based on a efficacy of chemotherapy potency oncology compounds. proprietary allogeneic by enhancing drug delivery • Recent clinical trial data from cell line of Plasmacytoid • Reduced tumor hypoxia patients with solid tumors that were treated with immune Dendritic Cells due to exercise-induced checkpoint • PDC*line is much more vascular remodeling has inhibitors demonstrate that potent to prime and implications for radiation CD8+ T cells can mediate deep boost antitumor therapy and and durable responses in solid antigen, including immunotherapy tumors. neoantigens, specific • How to identify TCRs and cytotoxic T-cells than pMHC targets involved in

conventional vaccines Keri Schadler, Assistant mediating complete responses and improves the Professor, MD Anderson following ICI treatment ? response to checkpoint Cancer Center (CONFIRMED) • The most promising inhibitors approaches to identify pMHC targets and their • The technology can be corresponding TCRs will be applied for any cancer discussed Eric Halioua, President and Hanspeter Gerber, SVP & CSO, 3T Chief Executive Officer, Biosciences (CONFIRMED) PDC*line Pharma (CONFIRMED) 2:40pm TRuCs, a novel engineered T Reserved for supporting partner. If Precision engineering to Potentiating the NK cell Reserved for supporting partner. If cell approach to the you are interested in being involved, advance adoptive T cell response to solid tumours to you are interested in being involved, please contact Derek Cavanagh at please contact Derek Cavanagh at treatment of solid tumors [email protected] or therapies overcome the TME [email protected] or +44 (0)207 092 1297 • Advantages of targeting • Induction of NK cell +44 (0)207 092 1297 Alfonso Quintas, Chief CAR and TCR transgene hyporesponsiveness by Medical Officer, TCR2 into the TRAC locus tumor cells Therapeutics (CONFIRMED) • Scaling up the TRAC-CAR T • Role of Treg and MDSC in cells GMP manufacturing suppression of intra- • An Immunocompetent tumoral NK responses mouse model to study • The effect of hypoxia on NK Allogeneic CAR T cells cell reactivity Justin Eyquem, Principal Mark Lowdell, CSO, InMune Bio Investigator - Parker Fellow, (CONFIRMED) UCSF (CONFIRMED) 3:00pm Improved cancer therapy Synthetic DNA-based Role of endogenous immune Title TBA Reserved for supporting partner. If using engineered human immunotherapies for cancer cells in glioma you are interested in being involved, please contact Derek Cavanagh at pluripotent stem cells treatments microenvironment during CAR Steven Kelly, CEO, Carisma [email protected] or • Efficient Development of • Synthetic DNA with T cell therapy Therapeutics (CONFIRMED) +44 (0)207 092 1297 natural killer (NK) cells Active Adaptive • Our team is clinically from human pluripotent Electroporation have evaluating IL13Rα2- stem cells come of age as a leading targeted CAR-T cells for the • Strategies to use human immunotherapy treatment of recurrent pluripotent stem cells as platform IL13Rα2-positive MGs a platform to produce • Inovio's [NCT02208362] human NK cells with immunotherapies • We have established a improved anti-tumor function exclusively in syngeneic activity vivo, generating immunocompetent glioma

• Clinical translation of antigen-specific cellular model, which recapitulates human pluripotent stem responses against the tumor cell-derived NK cells targeted diseases microenvironment (TME) of Dan Kaufman, Professor of demonstrated in clinical patients Medicine, Director of Cell trials • Murine IL13Rα2-CAR-T cells Therapy, UCSD (CONFIRMED) • Versatility of the mediate potent antitumor platform allows for activity against IL13Rα2- complex formulations engineered KR158, a highly co-delivering Synthetic invasive murine glioma DNA encoding for TAAs, model genetic adjuvants, mAb • Characterization of the and bispecifics tumor microenvironment Laurent Humeau, CSO, EVP post-CAR-T therapy of Research, Engineering and indicates activation of Clinical Developments, endogenous cytotoxic CD8 Inovio Pharmaceuticals T and myeloid cells, and (CONFIRMED) decrease in the frequency of T regulatory cells. Further analyses reveal that tumor-associated macrophages (TAMs) may be reprogrammed during CAR-T therapy to exhibit tumoricidal activity and may promote the activation of endogenous T cells (CD4/CD8 T cells) resulting in enhanced antitumor activity. • Our data strongly suggest that CAR-T therapy has the potential to reshape the glioma microenvironment creating a context permissible to elicit effective endogenous antitumor immunity.

Darya Alizadeh, Assistant Research Professor, City of Hope (CONFIRMED) 3:20pm Networking break Cell Therapy Cancer Vaccines Tumor Microenvironment Solid Tumours Technology showcase Chair: Bob Valamehr, Chief Development Officer, Fate Therapeutics 4:10pm Arming T cells to target solid Supercharging the tumor Targeting sTNF to manipulate A novel therapeutic platform Reserved for supporting partner. If tumors microenvironment with the the TME in Breast Cancer that delivers you are interested in being involved, please contact Derek Cavanagh at • Arming ex vivo expanded engineered cytokines NKTR- • Local mechanisms of immunomodulatory payloads [email protected] or T cells with bispecific 214 and NKTR-255 resistance to to tumor-resident myeloid cells +44 (0)207 092 1297 antibodies creates an • Cytokines are powerful immunotherapy after IV dosing and army of anti-tumor CTLs agents that can provide • Role of MUC4 in resistance demonstrates potent anti- • Infusions have produced expansion and to trastuzumab in HER2+ tumor efficacy in preclinical encouraging clinical differentiation for breast cancer studies results in breast and effector cells. In their • Targeting soluble TNF to • Many experimental pancreatic cancer native state they are prevent MUC4 expression therapies developed to • Infusion of targeted T poor medicines. and reverse resistance to promote proper T-cell cells leads to in situ • Engineered cytokines trastuzumab infiltration in immune- immunization of the can more effectively RJ Tesi, CEO/CMO, InMune Bio excluded tumors are too patients endogenous stimulate cytokine (CONFIRMED) toxic for systemic immune system to receptor pathways, administration, which will produce a long-term anti- while controlling be required in a metastatic tumor effect adverse events. disease setting. Larry Lum, Professor, Director • The combination of • We have engineered a of Cellular Therapy, Scientific NKTR-214 with Opdivo highly attenuated, Director of Bone Marrow has demonstrated microbial-based Transplant, University of powerful anti-tumor immunotherapy platform Virginia (CONFIRMED) effects and profoundly called STACT (S. alters the tumor Typhimurium Attenuated microenvironment, Cancer Therapy). Upon IV increasing effector T-cell administration, the counts, increasing PD-1 microbe traffics to and expression on tumor T- enriches in the tumor cells, and converting PD- microenvironment. There, L1 negative tumors to it is specifically

positive, while phagocytosed and lysed by maintaining a more tumor-resident myeloid tolerable AE profile than cells, enabling efficient traditional cytokine delivery of plasmids therapies encoding • NKTR-255 is an immune immunomodulatory cytokine that can payloads selectively grow NK cells • Using our proprietary and CD8 memory T cells platform, we have in the patient’s body. generated multiple This allows for the systemically-administered potential to combine therapies that target NKTR-255 with ADCC several well-characterized, mabs and to induce long yet intractable immune term survival of CAR-Ts pathways. Characterization Loui Madakamutil, SVP, of STACT microbes Head of Biology and encoding constitutively Preclinical Development, active STING variants Nektar Therapeutics (STACT-STING) and IL-2 (COFIRMED) (STACT-IL2) are provided as examples Christopher Thanos, CEO, Actym Therapeutics (CONFIRMED) 4:30pm Deep PrimedTM T cell therapy Tedopi: neo-epitope cancer Title TBA Cell-Based therapies for solid Reserved for supporting partner. If leverages natural biology for vaccine to tackle resistance tumors you are interested in being involved, please contact Derek Cavanagh at superior efficacy against to immune checkpoint Shannon Turley, Staff Scientist • Brief historical overview of [email protected] or solid tumors inhibitors and Group Leader in Cancer cell therapies for solid +44 (0)207 092 1297 • Success of T cell • Tedopi®is a mature Immunology Discovery, tumors therapies against solid multiple neoepitope Genentech (CONFIRMED) • CNMC experience: NK cell tumors has been limited cancer vaccine with based approaches for solid • Torque has developed its ongoing phase III clinical tumors Deep PrimedTM T Cell trial in NSCLC after anti- • CNMC experience: T cell Immunotherapy PD(L)1 failure and phase based approaches for solid platform. Here, the II in PDAC in tumors patient's own T cells are combination with the first primed and anti-PD1 Opdivo expanded by autologous

dendritic cells presenting • A precision medicine C. Russell Cruz, Assistant multiple shared or viral cancer vaccine for HLA- Professor, Children’s National tumor antigens. Next, the A2+ patients fighting Hospital (CONFIRMED) resulting multi-targeted T tumor antigens cells (MTC) are loaded heterogeneity by with nanoparticles whose covering different tumor payloads are designed to antigens overcome the above • An Off-the-Shelf and bottlenecks to efficacy. Ready-to-Use emulsion Finally, these Deep of a proprietary PrimedTM MTC are combination of 10 infused back into the neoepitopes patient in a multi-dosing • Breaking self-tolerance regimen. They home to by rational design of TME and tumor draining fixed-anchor and lymph nodes, where they heteroclitic neoepitopes release their payloads in increasing MHC/TCR a controlled manner. This affinities and inducing maximizes efficacy at the antigen-specific target organs and limits cytotoxicity systemic exposure. Nicolas Poirier, Chief • Deep PrimedTM T cell Scientific Officer, OSE therapy leverages broad Immuno Therapeutics and natural repertoires (CONFIRMED) of antigens and T cells for superior efficacy, does not require T cell genetic engineering, and utilizes powerful immunomodulating payloads whose systemic administration is toxic. These benefits are produced at a fraction of the cost of CAR-T and TCR-T cell therapies. • In my talk, I will introduce this

groundbreaking technology, present key data demonstrating its extraordinary safety and efficacy, and highlight underlying mechanisms Karsten Sauer, Vice President, Immunology, Torque Therapeutics (CONFIRMED) 4:50pm Multi-antigen specific Reserved for supporting partner. If Metabolism Title TBA Reserved for supporting partner. If endogenous T cell therapy you are interested in being involved, Targeting immunometabolism you are interested in being involved, please contact Derek Cavanagh at please contact Derek Cavanagh at consisting of stem cell and [email protected] or as a novel strategy to fight Christine Brown, Associate [email protected] or central memory T cells with +44 (0)207 092 1297 cancer Research Professor, City of +44 (0)207 092 1297 potent anti-tumor activity for • Metabolism and function of Hope (CONFIRMED) the treatment of cancer cells and immune hematologic malignancies cells are altered in the • Company sponsored P1/2 context of a tumor and trials in AML and MM tumor microenvironment • NexImmune’s AIM leading to tumor immune expanded T cell products evasion include populations of • Altered primed antigen-specific immunometabolism CD8+ T cells directed at pathways provide a rich multiple tumor relevant opportunity for antigen targets pharmacological • T cell products with high intervention proportion of stem cell • Targeting and central memory T glutamine metabolism has cell subtypes are been identified as a associated with long- promising approach and term T cell persistence a potential new treatment and durable anti-tumor paradigm with broad activity application for many cancer • NexImmune’s proprietary types T cell products may Robert Wild, Chief Scientific address key limitations Officer, Dracen pharmaceuticals (CONFIRMED)

observed with genttically modified T cell products; specifically, tumor escape through single target down-regulation and tumor relapse due to diminished T cell persistence Scott Carmer, CEO, NexImmune (CONFIRMED) 5:10pm Development of off-the-shelf Utilizing a live modified Presentation available Differential response of mouse Reserved for supporting partner. If therapeutic T-cells resistant Vaccinia Ankara virus to glioma models to you are interested in being involved, please contact Derek Cavanagh at to host immune rejection deliver tumor associated immunotherapeutics: [email protected] or and superior anti-tumor antigen MUC1 on understanding the underlying +44 (0)207 092 1297 activity the surface of virus like mechanism • Alloimmune defense particles • CAR T cell therapy and PD1- receptors (ADRs) enable • Design of a MVA-MUC1 blockade in treatment of T-cells to recognize and VLP "hot" and "cold" mouse eliminate activated • In vitro characterization GBMs pathogenic T- and NK- of production of hypo • Propose strategies to cells glycosylated MUC1 in overcome tumor resistance • ADR T-cells resist infected cells Sharareh (Sherri) Gholamin, immune rejection by • Therapeutic Efficacy of Researcher, Caltech allogeneic T- and NK-cells MVA-VLP-MUC1 vaccine (CONFIRMED) in vitro and in vivo in Human MUC1 • T-cells co-expressing ADR transgenic mice and CAR evade immune Farshad Guirakhoo, CSO, rejection and promote GeoVax (CONFIRMED) long-term anti-tumor activity in mouse models of "off-the-shelf" cell therapy Maksim Mamonkin, Assistant Professor, Baylor College of Medicine (CONFIRMED) 5:30pm Offsite drinks reception

Day 2 – Tuesday March 3rd 2020 8:00am Registration opens 8:30am Doors open Day 2 opening keynotes Combination Therapies in Antibodies and Immunotherapy 9:00am Chair’s opening remarks Roy Baynes, Senior Vice President and Head Global Clinical Development, Chief Medical Officer, Merck 9:05am PD-1 antibodies are transforming cancer treatment both as monotherapy and in combination • Monotherapy activity has been established and is transforming treatment across a number of major cancers • Precision medicine has been deployed to identify patients most likely to respond and those for whom a combination approach might be preferred • Precision medicine has enabled prediction of potentially important combination therapies • Combination therapies are now beginning to transform treatment across a number of cancers • PD-1 antibodies have become foundational in cancer therapy Roy Baynes, Senior Vice President and Head Global Clinical Development, Chief Medical Officer, Merck (CONFIRMED) 9:25am Building a leading off-the-shelf, allogeneic T-Cell immunotherapy company • Epstein-Barr virus (EBV) is associated with a wide range of cancers and multiple sclerosis (MS) • Tab-cel® (tabelecleucel) is an off-the-shelf, allogeneic EBV T-cell immunotherapy in Phase 3 development for patients with EBV+ post-transplant lymphoma as well as other serious EBV-associated ultra-rare diseases • ATA188 is an off-the-shelf, allogeneic T-cell immunotherapy that targets EBV-infected B cells believed to play a role in the pathogenesis of MS • EBV T cells also have potential application as an off-the-shelf, allogeneic CAR T platform • ATA2271/ATA3271 are novel mesothelin-targeted CAR T programs incorporating next-generation technologies for patients with advanced solid tumors • Atara’s platform is supported by state-of-the-art T-cell manufacturing that is commissioned and qualified to support clinical development Pascal Touchon, President and CEO, Atara Biotherapeutics (CONFIRMED) 9:45am Strategies for combination therapies with CD19 CARTs in NHL - lessons learned and future directions • CD19 CAR Ts have demonstrated notable activity in DLBCL, CLL, FL, pALL and other hematological malignancies with high overall response rates and durable CRs • However, a portion of patients either do not respond or their responses are not durable • Learnings from non-responders or CAR-T relapses are providing data into the multitude of potential resistance/suppression mechanisms • This presentation will review combination approaches being evaluated to overcoming resistance in CAR T to improve outcomes in NHL and provide insights for solid tumor approaches and the next wave of targets

David Fontana, Head Strategic Alliance & JCAR017 Program Lead, Juno Therapeutics (CONFIRMED) 10:05am Quantitative modelling and simulation approaches: Driving critical decisions from research through clinical trials • Quantitative Systems Pharmacology (QSP) is a mathematical modeling and engineering approach to translational medicine that aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms • Several examples will be shown which highlight QSP efforts to accelerate the discovery and development of best-in-class therapeutics and impact critical decisions, in the continuum from preclinical exploration to clinical research • Examples will include providing biological understanding, impact on new target proposals, lead generation, clinical candidate selection, IND support, and clinical trial go/no go decisions from industry John M. Burke, Co-Founder, President and CEO, Applied Biomath (CONFIRMED) 10:25am Morning networking break 10:30- WORKSHOP: Operationalizing pediatric and adult cell therapy trials 11:15am Brenda Hann, Director, Clinical Trials Operations, Stanford Medicine (CONFIRMED) Janet McDowell, Clinical Research Manager, Stanford University School of Medicine - Cancer Clinical Trials Office (CONFIRMED) Theresa Latchford, Oncology Clinical Nurse Specialist, Stanford Health Care - Blood and Marrow Transplant Unit (CONFIRMED) Anne Cunniffe Marcy, Clinical Research Coordinator, Stanford University School of Medicine - Cancer Clinical Trials Office (CONFIRMED) Checkpoint Inhibitors Commercialization and Gene Therapy and CRISPR Clinical Trials Antibodies in Market Access Immunotherapy Chair: Ezra Cohen, Associate Chair: Prentice Curry, Senior Chair: C. Russell Cruz, Assistant Director, U.C. San Diego Vice President Quality and Professor, Children’s National Moores Cancer Center Compliance, Kite Pharma Hospital 11:25am Checkpoint Inhibitors in Head Kite Pharma experience in Tumor-specific immunogene Being the collaborator of Title TBA and Neck Squamous Cell the global commercial launch therapy with T-SIGn viruses choice for combination Carcinoma" of a CAR-T product • T-SIGn is a broad cancer- studies Bruce Keyt, CSO, IGM • review current data for • Preparation for targeted gene therapy • Reviewing how this all Biosciences (CONFIRMED) anti-PD1 therapy in HNSCC commercial launch in the platform for delivery and started • define current research US and globally local expression of • Exploring how approaches to improve • Special considerations for combinations of genes work has evolved and efficacy qualification of medical for the treatment of solid what does that mean • determine strategies to centers tumors. T-SIGn utilizes • Working treat anti-PD1 refractory • Rapid manufacturing, enadenotucirev (EnAd), a with collaborators in patients release and distribution first generation oncolytic order to optimize Ezra Cohen, Associate Director, present challenges virus with demonstrated performance U.C. San Diego Moores Cancer Prentice Curry, Senior Vice intravenous delivery, as a • Highlighting key factors Center (CONFIRMED) President Quality and gene delivery vector for in making all Compliance, Kite Pharma up to five transgenes, collaborations successfu (CONFIRMED) providing simultaneous l expression of

combinations of • Presenting advantages, biotherapeutics locally challenges & lessons within the tumor learned microenvironment, while Denise Steckel, Head, minimizing systemic Clinical Collaborations exposure to these same Management, Genentech agents (CONFIRMED) • T-SIGn viruses are administered intravenously to reach both primary and metastatic tumor tissue. The transgenes are encoded under the control of the virus major late promoter such that during selective virus replication in tumors the payload biotherapeutic proteins are produced to fight the cancer locally • A variety of viruses encoding different immunomodulatory agents have been generated and functionally characterized, with three progressing into clinical trials: NG-348 (membrane anti-CD3 and CD80), NG-350A (agonist anti-CD40 antibody) and NG-641 (FAP-targeted T- cell activating bispecific antibody plus CXCL9, CXCL10 and IFNa)

• Properties of the T-SIGn platform, including clinical experience with the unarmed parental EnAd virus, and activity data from specific virus candidates will be discussed Brian Champion, CSO, PsiOxus Therapeutics (CONFRMED) 11:45am Replication stress response Launch and Reserved for supporting partner. If Reserved for supporting partner. If CDX-1140, a unique Agonist defects predict response to Commercialization Insights you are interested in being involved, you are interested in being Anti-CD40 mAb for cancer please contact Derek Cavanagh at involved, please contact Derek immune checkpoint blockade in for Gene and Cellular [email protected] or Cavanagh at Immunotherapy non-hypermutated cancers Therapy Products +44 (0)207 092 1297 [email protected] or • CD40 plays key roles in • We demonstrate that a • How should you think +44 (0)207 092 1297 innate and adaptive replication stress response about the market: immune responses, and (RSR) defect gene traditional GTM strategy targeting CD40 can expression signature versus Customized GTM promote tumor regression accurately predicts immune • How to think about via multiple mechanisms checkpoint blockade (ICB) market access strategy • CDX-1140 is a fully human response in 10 independent • LCM is key component to IgG2 agonist anti-CD40 non-hypermutated patient this lifeline of the product mAb selected based on a cohorts from 5 tumor in this space linear dose response and lineages for which other Mohamed Ladha, Vice hypothesized to achieve biomarkers failed President and Head, good systemic exposure • Pre-clinical studies indicate Commercial, Tocagen and tumor penetration that aberrant origin firing in (CONFIRMED) without dose-limiting RSR deficient tumor cells toxicity observed with causes exhaustion of other potent agonist anti- replication protein A, CD40 mAbs resulting in accumulation of • CDX1140-01 is a Phase 1 immunostimulatory dose-escalation study with cytosolic DNA. tumor specific expansion • Pharmacological RSR defect cohorts of CDX-1140 alone induction further enhance or in combination with CDX-301, a potent dendritic

the responses of cancers to cell growth factor, in ICB patients with advanced Shiaw-Yih (Phoebus) Lin, cancer; preliminary data Professor and Deputy Chair, MD from the study will be Anderson Cancer Center presented (CONFIRMED) Michael Yellin, VP, Clinical Science, Celldex Therapeutics (CONFIRMED) 12:05pm CUE-101, a novel Fc fusion Title TA Title TBA Using data analytics to T cell redirecting antibody protein for selective targeting overcome challenges with circuits: Bispecifics with a and expansion of anti-tumor T Michael J. LaBarre, Senior Vice clinical trials data unique “AND” gate to enhance cells for treatment of HPV- President, Chief Technology Douglas Jolly, Executive Vice • Conducting clinical trials tumor specificity Officer, Halozyme (CONFIRMED) driven malignancies President, Research and can be challenging. • Harnessing the Immune • CUE BioPharma’s Pharmaceutical Development, • Challenges can include System, in particular ImmunoSTATs are Tocagen (CONFIRMED) setting up databases, redirected T-cells to kill proprietary biologics that recruitment of tumor cells has incorporate, in a single participants, missing revolutionized cancer molecular framework, the data issues on key treatment. However, on key signals needed to variables of interest etc. and off-target toxicity limit selectively • Ideas for overcoming the therapeutic potential of modulate antigen-specific T these challenges using these approaches cells: namely, the HLA- novel data analytic • Revitope is developing T peptide complex to target techniques will be cell redirecting antibody the TCR along with relevant discussed from a Data circuits that use dual- co-stimulatory/co-inhibitory Scientist’s perspective targeting to deliver split signals, dependent upon Jay Mandrekar, Professor of anti-CD3 paratopes to the the disease indication. Biostatistics and Neurology, tumor. Reconstitution is • The protein framework Mayo Clinic (CONFIRMED) only permitted after of ImmunoSTATs is based protease cleavage in the on an Ab Fc backbone and tumor microenvironment is extremely modular and to remove the stabilizing flexible, which permits for dummy domain. This targeting of diverse approach is designed to patient populations and initiate and focus T cell different diseases. mediated cytotoxic • The lead clinical immunity accurately on the candidate CUE-101 is tumor sparing normal comprised of HLA-A*0201 tissues

bound to • We will discuss protein a peptide epitope derived engineering considerations, from the HPV16 E7 protei in vitro and in vivo activity n (amino acid residues 11 measurements, half-life -20) along with affinity- and the use of quantitative attenuated human systems pharmacology interleukin-2 (IL-2) to modelling approaches to selectively activate and aid mechanistic expand HPV16 E711-20- understanding specific CD8+ T cells for Werner Meier, CSO, Revitope HPV-driven malignancies, Oncology (CONFIRMED) such as head and neck cancer and cervical cancer Saso Cemerski, Senior Director of Translational Immunology, Cue Biopharma (CONFIRMED)

12:25pm CB213: A second generation Engineering T cells for the Planning biomarker- Engineered antibody-secreting checkpoint inhibitor optimally immunotherapy of pediatric enriched clinical trials and T cells configured for therapeutic brain tumors evidence synthesis to • Brief historical overview of efficacy • Immunotherapy improve precision medicine antibody-secreting T cell • The identification and challenges for brain practice technology characterisation of CB213 a tumors • Successful • Antibodies engineered to tetravalent trispecific • Genetic engineering personalization of mediate ADCC can be therapeutic delivering dual approaches to improve medicines requires secreted by T cells checkpoint blockade CAR T cells unbiased data • Results in HIV suggest through dual inhibition of Giedre Krenciute, Assistant collection from platform linking innate and PD-1 and Lag3 Member, St. Jude Children’s prospectively planned adaptive components via • The case study will describe Research Hospital biomarker-enriched antibodies is feasible the approach taken to (CONFIRMED) clinical studies, C. Russell Cruz, Assistant select a novel asymmetric objective evidence Professor, Children’s National format on the basis of synthesis utilizing pre- Hospital (CONFIRMED) optimal target engagement specified statistical and activity using the analyses, and practical modular Humabody format presentation and communication of such evidence

• Data will be presented • In this presentation, I showing that this molecule will illustrate how such is able to reverse the clinical studies can be dysfunctional phenotype of planned to optimize patient derived human T- probability of trial cells which are non- success and to generate responsive to clinical PD1 evidence of both antibodies therapeutic clinical James Legg, SVP Research and efficacy and probability Development, Crescendo of meaningful clinical Biologics (CONFIRMED) benefits to individual patients • Such well-considered planning will allow efficient development of precision medicines to satisfy multiple stakeholders including regulators, prescribers, payers and, ultimately, to benefit individual patients Deepak Khatry, Science Associate Director, Oncology Biometrics, AstraZeneca (CONFIRMED) 12:45pm Networking lunch 12:50- WORKSHOP: Panel discussion - patients as partners in clinical development 1:20pm • How can we collaborate more with patients? • Improving transparency • Public awareness of clinical trials Moderator: Julie Gerberding, Executive Vice President, Communications, Global Policy, and Population Health & Chief Patient Officer, Merck (CONFIRMED) Eve Bukowski, Vice President, Patient Advocacy, Education & Outreach, California Life Sciences Association (CLSA) (CONFIRMED) Joann Peters, Vice President Clinical Operations, Geneos Therapeutics (CONFIRMED) Checkpoint Inhibitors Commercialisation and Gene Therapy and CRISPR Clinical Trials Antibodies in Market Access Immunotherapy

Chair: Greg Babcock, Vice President, Research, Visterra Inc 2:00pm Targeting Siglec-15 for cancer Panel discussion: from Nanotechnology-Enabled Early phase development of Structure-guided design of an immunotherapy clinical trials to commercial Assembly Lines for Gene and biomarker-specific agents IL-2-based therapeutic that • The development and manufacturing Stem Cell-Based Therapies • Balancing inclusion selectively activates regulatory characterization of NC318, • How to achieve • The capability to mass criteria, safety T cells a novel therapeutic commercial capacity produce populations of monitoring, biomarker • Several novel IL-2 antibody targeting Siglec-15 • Overcoming the lack of engineered cells to serve expression mutations that enhance • Brief updates on NC318 mature CROs as cellular therapies • Incorporating selectivity of IL-2 for Tregs Phase I clinical trial • Technical operations – remains a considerable companion diagnostics, will be discussed • The case study will describe scaling up translational challenge. dose escalation or • Enhanced half-life of the IL- the approach taken to • Engaging with regulators New intracellular delivery expansion phase? 2 muteins in vivo select novel targets derived • Supply chain challenges technologies that can • Strategies for moving • Selective expansion of from NextCure’s FIND-IOTM • Cost and resources simultaneously satisfy from first-in-human Tregs in vivo, with modest platform Moderator: Prentice Curry, universal cargo delivery study to accelerated to no activation of NK cells Linda Liu, SVP, Research, Senior Vice President Quality economically with high approval or Th cells NextCure (CONFIRMED) and Compliance, Kite Pharma efficiency, high Christina Annunziata, Head, • Efficacy in disease models (CONFIRMED) processing throughputs, Translational Genomics of autoimmunity Bob Valamehr, Vice scalability, and minimal Section, NIH (CONFIRMED) Greg Babcock, Vice President, President, Cancer cell toxicity are needed Research, Visterra Inc Immunotherapy, Fate • Ideas inspired by (CONFIRMED) Therapeutics (TBC) microfluidics, Christina Yi, Chief Operations nanolithography, and Officer, Dendreon nanorobotics are (CONFIRMED) combined with gene editing to generate broadly applicable and translatable methods to enable rapid, safe, cost effective, and efficient delivery of biomolecular cargo • Solutions that enable the controlled and temporary permeabilization of the processed cells via either i) physical penetration of

cellular membranes by precision-engineered nanostructures or ii) mechanical manipulation of cellular membranes are promising alternative strategies to existing viral and non-viral vector- based approaches Steven Jonas, Researcher, UCLA (CONFIRMED) 2:20pm Reserved for supporting partner. If you Title TA Presentation available Reserved for supporting partner. If T cell engaging bispecific are interested in being involved, please you are interested in being antibodies: Comparing Pfizer’s contact Derek Cavanagh at involved, please contact Derek [email protected] or +44 Michael J. LaBarre, Senior Cavanagh at platforms (0)207 092 1297 Vice President, Chief [email protected] or • T-cell engaging bispecific Technology Officer, Halozyme +44 (0)207 092 1297 antibodies are a promising (CONFIRMED) therapeutic approach for the treatment of multiple cancer types. • Pfizer has developed several Fc-containing T-cell engaging bispecific antibody platforms, which increase the half-life and allows for conventional dosing. These platforms are currently evaluated in the clinic. • We will compare these platforms and the challenges and opportunities of each platform will be highlighted Javier Chaparro-Riggers, Executive Director, Pfizer (CONFIRMED)

2:40pm Defining T Cell states associated Panel discussion: from Engineered T cells for Clinical trial disclosure and Development of NM21-1480 a with response to combination clinical trials to commercial sarcoma transparency – managing trispecific anti-PD-L1x4- immunotherapy manufacturing • Autologous T cells the ever-changing global 1BBxhSA antibody fragment Shahram Salek-Ardakani, Senior • How to achieve engineered to express regulations and • NM21-1480 is a novel Director, Cancer Immunology, commercial capacity chimeric antigen requirements trispecific antibody Pfizer (CONFIRMED) • Overcoming the lack of receptors (CARs) are safe • Global Clinical Trial fragment fusion protein mature CROs and may provide clinical Registration and Results directed against PD-L1 and • Technical operations – benefits in patients with Disclosure 4-1BB scaling up metastatic sarcoma • Public Release of • The molecule is designed to • Engaging with regulators • Responses following CAR Clinical Information block PD-1/PD-L1 signalling • Supply chain challenges T cell therapy may (Health Canada, EMA, and elicit an intratumorally • Cost and resources include involvement of FDA) restricted CD8+ T cell Moderator: Prentice Curry, endogenous immune • Drafting documents activation, promising a Senior Vice President Quality system resulting in tumor with the “end” in mind favorable benefit-to-risk and Compliance, Kite Pharma clearance. Nate Root, Associate profile (CONFIRMED) • Introducing engineered Director, Clinical Disclosure • In vivo experiments have Bob Valamehr, Vice signal receptors or gene & Transparency, Ionis shown efficacy and President, Cancer knockouts can improve Pharmaceuticals tolerability and the Immunotherapy, Fate CAR T cell function and (CONFIRMED) molecule is expected to Therapeutics (TBC) persistence Kelly Coulbourne, Associate enter clinical testing in Christina Yi, Chief Operations Sujith Joseph, Senior Director, Clinical Trial Data Q3/2020 Officer, Dendreon Scientist, Baylor College of Registries, Allergan Sebastian Meyer, COO, Numab (CONFIRMED) Medicine (CONFIRMED) (CONFIRMED) Innovation AG (CONFIRMED) 3:00pm Bispecific anti-PD1 checkpoint Reserved for supporting partner. If Tumor-targeted immune- inhibitors to address cancer you are interested in being involved, stimulating antibody please contact Derek Cavanagh at immunotherapy resistance [email protected] or conjugates mechanisms +44 (0)207 092 1297 • 3-4 bullet points covering • Second generation of PD-x the scope of your talk inhibitors will extend the • Immune-stimulating spectrum of patients antibody conjugates (ISACs) responding to are tumor-targeting immunotherapies by antibodies conjugated with addressing untapped powerful innate immune immune evasion stimulants mechanisms. • ISACs are capable of • BiCKI® is a proprietary invoking potent myeloid bispefic fusion protein cell activation and the

platform built on an production of pro- engineered key backbone inflammatory cytokines anti-PD1 and targeting that favor a productive innovative targets. anti-tumor immune • The BiCKI® platform strives response to inhibit key immune • ISACs are active in checkpoints while simulfe preclinical in vivo models of taneously delivering cancer and are highly intratumoral cytokines with efficacious by enhancing Treg modulating function ADCP, promoting antigen and/or increasing presentation, exhausted T cells responses. immunological memory, • The BiCKI® platform can also and epitope spreading delivers costimulatory David Dornan, Senior Vice signals to rewire anti- President of Research, Bolt tumoral T-cell activities or Biotherapeutics (CONFIRMED) other modalities reinstating, among others, macrophage polarization and phagocytic functions Nicolas Poirier, Chief Scientific Officer, OSE Immuno Therapeutics (CONFIRMED) 3:20pm Afternoon networking break Checkpoint Inhibitors Precision Immunotherapy Gene Therapy and CRISPR Clinical Trials Antibodies in and Biomarkers Immunotherapy Chair: C. Russell Cruz, Assitant Professor, Children’s National Hospital 4:00pm Evolving field of Eat Me and Photoimmunotherapy, a new Non-viral engineering of Clinical trial designs Mechanisms of action of a Don't Eat Me Science tumor targeted approach immune cell specificity and neoantigen-targeting antibody • Review of Macrophage that activates immune anti- function Barbara Hickingbottom, NEO-201 Interactions with Tumors cancer responses and • Non-viral genome Vice President, Clinical • This study demonstrates • Review of Therapies reduces cellular tumor targeting is a new, simple Development, Xencor that NEO-201 has several targeting CD-47 and SIRP immunosuppression method for targeted (CONFIRMED) mechanisms of action. alpha • Photoimmunotherapy is a integration of new NEO-201 is able to mediate new cancer platform that both ADCC and CDC.

• Current clinical trials enables the rapid genetic information in • In addition, NEO-201 can targeting CD-47 and SIRP destruction of cellular primary human T cells block the interaction alpha components within the • Targeted replacement of between tumor cell Corey Carter, CEO, EpicentRx tumor. the endogenous T cell CEACAM5 and NK cell INC (CONFIRMED) • Photoimmunotherapy receptor with a cancer CEACAM1 to reverse targeting of cancer cells antigen targeting TCR CEACAM1-dependent induces innate and showed specific anti- inhibition of NK adaptive immune tumor function in cytotoxicity. responses that are vitro and in vivo • These results suggest that synergistic with immune • Pooled knock-in NEO-201 may potentially checkpoint inhibitors. screening based on non- reverse CEACAM1- • Targeted depletion of viral genome targeting dependent tumor enabled rapid discovery immunosuppression of NK immunosuppressive of synthetic DNA cells in patients whose components with sequences that along tumors express the NEO- Photoimmunotherapy, with a new TCR specificity 201-reactive variant of such as T-regs, induces enhanced T cell function CEACAM5. rapid and sustained anti- in vivo. • NEO-201 can also target cancer immune Theodore Roth, Research and eliminate human responses with strong Fellow, UCSF (CONFIRMED) immunosuppressive synergy with immune regulatory T cells (Tregs). checkpoint inhibitors • Additional mechanisms are Miguel Garcia-Guzman, Chief under investigation Scientific Officer, Rakuten Al Tsang, CSO, Precision Medical (CONFIRMED) Biologics (CONFIRMED) 4:20pm Multiparametric flow Use of biomarkers for Reserved for supporting partner. If The importance of dose Bispecific antibodies for guided cytometry analysis of precision immunotherapy you are interested in being involved, optimization in the inhibition of CD47 please contact Derek Cavanagh at immunomodulatory receptors [email protected] or development and approval • CD47-SIRPa axis, a in dissociated tumour and Vassiliki +44 (0)207 092 1297 of immunooncology drugs phagocytosis checkpoint, is matched blood biospecimens Papadimitrakopoulou, a promising target for • Discussion of the limitations Professor of Medicine in the Sandhya Girish, Senior cancer immunotherapy. of IHC and sequencing for Department of Thoracic/Head Director, Global head Yet, therapeutic inhibition IMR discovery that can be and Neck Medical Oncology, Oncology, Genentech of CD47 on tumor cells is alleviated by MD Anderson Cancer Center (CONFIRMED) hindered by ubiquitous multiparametric flow (CONFIRMED) expression of the target in cytometry analysis healthy tissue

• Discussion of the • Undesirable on-target/off- optimization of flow tumor effects typically cytometer instrument observed with CD47 settings and gating analysis blocking monoclonal strategies for dissociate antibodies can be largely tumours vs blood samples mitigated with a bispecific • Exploration of IMR antibody, which enable expression at the single-cell guided (i.e., selective) level across cellular subsets inhibition of CD47 on present in matched tumour cancer cells and blood samples • Such CD47-blocking • Advanced analysis using bispecific antibodies show high dimensional flow potent anti-tumor activity cytometry data associated with favorable Shawn Fahl, Director, Flow pharmacokinetics and Cytometry Services, Discovery safety profiles Life Sciences (CONFIRMED) Krzysztof Masternak, Head of Discovery, Light Chain Bioscience – a brand of Novimmune SA (CONFIRMED) 4:40pm Affimer therapeutics: Reserved for supporting partner. If Clinical experience with T Panel discussion: clinical A novel platform for T-cell generation of checkpoint you are interested in being involved, cells expressing NY-ESO-1 trial opportunities and redirection that elicits efficient please contact Derek Cavanagh at inhibitor antagonists with [email protected] or TCR and CRISPR edited to designs for cell therapies tumour lysis with minimal broad applications +44 (0)207 092 1297 eliminate endogenous TCR • What’s the definition of cytokine release in multiple • The Affimer platform is and PD-1 personalised medicine? tumour types based on the human • NY-ESO-1 is a cancer • Ethical considerations • Discovery of novel CD3 protease inhibitor, Stefin A, testis antigen with • Keeping the patient binding antibodies where we have introduced aberrant expression in engaged during long • Unique functional activity 2x9 aa loops into the myelomas, sarcomas, and vaccine manufacturing based on novel epitope and backbone to generate large melanomas. times affinity phage display libraries. • This talk will present Joann Peters, Vice President • T-cell redirecting bispecific Using phage display we updated data from a Clinical Operations, Geneos antibodies that efficiently have generated a range of phase 1 pilot clinical trial Therapeutics (CONFIRMED) lyse tumors with low levels antagonists and agonists ( NCT03399448) enrolling Barbara Hickingbottom, of cytokine release with nM affinities to targets patients with advanced Vice President, Clinical • TNB-383B lead molecule that are central to the MM and sarcoma. Development, Xencor currently in phase 1 clinical modulation of the immune (CONFIRMED) development

system in the tumour • This trial evaluates a first- Christina Annunziata, Head, Nathan Trinklein, Chief microenvironment in-human engineered cell Translational Genomics Technology Officer, Teneobio • With our anti-PDL1 Affimer therapy of T cells Section, NIH (CONFIRMED) (CONFIRMED) Fc we have demonstrated expressing a TCR total tumour regression in recognizing a HLA-A201 mouse syngeneic models in restricted NY-ESO- combination with an iDASH 1/LAGE-1 epitope inhibitor and immunity to (SLLMWITQC), and with rechallenge with tumour CRISPR/Cas9 edited cells, showing that we have TCRα, TCRβ, and PDCD1 achieved an immune genes memory response. We have Simon Lacey, Director, The expanded the use of our Center for Cellular anti-PDL1 Affimer Immunotherapies, University therapeutics by encoding of Pennsylvania them into DNA and have (CONFIRMED) shown that they can be expressed at high levels as function proteins from primary human cells. • With our anti-PDL1 and LAG-3 Affimer proteins, we have generated high affinity bispecific formats with affinities in the double/triple digit pM range. Using primary human cell based assays we have shown that the combination of PD-L1 and LAG-3 blockade showed a significant increase in cytokine release compared to monovalent blockade alone Amrik Basran, Chief Scientific Officer, Avacta (CONFIRMED)

5:00pm Presentation available Identification of Neoantigens Presentation available Mucin (MUC)16-directed for cancer immunotherapy Immunotherapeutic strategies • Neoantigen identification for ovarian cancer for cancer immunotherapy • Use of bi-specific T-cell is a significant challenge engagers, which could • Tumor immunopeptidomics potentially induce antigen combined with deep learning spreading beyond the provides a powerful approach targeted tumor-associated for neoantigen prediction antigen • Gritstone’s EDGE prediction Olapado Yeku, Assistant Clinical model identifies Attending, Massachusetts therapeutically relevant General Hospital (CONFIRMED) neoantigens Roman Yelensky, EVP & Chief Technology Officer, Gritstone Oncology (CONFIRMED) 5:20pm Networking drinks and poster presentation session

Day 3 – Wednesday March 4th 2020 8:30am Registration opens 9:00am Doors open Neoantigens Oncolytic Viruses Non-Oncology Manufacture and Supply Research Hub Immunotherapy Chain Chair: TBA Chair: TBA Chair: TBA Chair: Rajesh Krishnan, Senior Chair: TBA Vice President, Process Development and Manufacturing, Oncternal Therapeutics 9:00am Going natural with ONCR-177, a Novel Micro- Synthetic DNA-based Cellular immunotherapy supply Personalized T cell recruiting Neoantigens RNA Attenuated Oncolytic immunotherapies for chain management, logistics bispecific autoantibodies for • The success of HSV Virus with Combinatorial emerging infectious diseases and scale-out treating cancer neoantigen vaccination Immune Payloads for the • Vendor qualification • Strategy to overcome will rely of accurately Treatment of Metastatic Kate Broderick, Vice President, • Maintaining chain of tumor antigen loss and target natural ligands that Cancer Inovio Pharmaceuticals custody for starting heterogeneity appear on tumor • Oncolytic virus with a (CONFIRMED) material and product • Tumor-specific targeting cells/APC, and dual mode of action, • Shipper suitability, features for tumors without coordination of both cancer cell killing and and options validated antigens CD4+ and CD8 T cell stimulation of antitumor • Material sourcing, receipt • Antibody conjugation subsets immunity are promising and testing method for site-specific, • We have developed a therapeutic approaches • Supply chain sustainability covalent modification novel HLA-agnostic for checkpoint and scale-out with nearly any antibody platform that functionally irresponsive tumors considerations • T cell recruiting identifies CD4+ and CD8+ • ONCR-177 expresses five Alan K. Smith, Executive Vice bispecific autoantibodies T cell neoantigens across transgenes (IL-12, CCL4, President, Technical using our production all tumor types analyzed, FLT3L and PD-1 and CTLA- Operations, Bellicum method function as regardless of mutational 4 antagonists) for potent (CONFIRMED) expected in vitro and in burden immune stimulation vivo

• Vaccination with a single • ONCR-177 tumor Fabiana Zappala, PhD peptide comprising CD4+ selectivity is enabled by Student, University of and CD8+ target the differential Pennsylvania (CONFIRMED) neoantigens identified by expression of microRNA our method can lead to Christophe Quéva, CSO, eradication of large Oncorus (CONFIRMED) established tumors in a preclinical model Stephen Schoenberger, Professor, La Jolla Institute for Immunology (CONFIRMED)

9:20am Harnessing the power of Engineering viruses to deliver Development of single dose Automated CAR T cell Dissecting virus-antibody patient T cell responses: their maximal potential: Two vaccines for emerging manufacturing platform for interactions with a vaccinia ATLAS™ platform examples from the Turnstone infection diseases using a hematologic and solid cancers virus-based display platform • Personalized immune portfolio novel MVA plug • Manufacture of CAR T cells • We display full-length response profiling drives and Play platform in support of Phase I hantavirus glycoproteins validation of antigens of Caroline Breitbach, VP R&D • Design of MVA-VLP and clinical trials using anti- on the surface of proven and pre-existing Programs and Strategy, non-VLP vaccines for Zika, CD19/22 bispecific CAR vaccinia virus particles CD4+ and CD8+ T cell Turnstone Biologics Ebola, Marburg and Lassa • Development of an • We generate vaccinia- responses (CONFIRMED) fever viruses automated closed displayed libraries of • Anti-tumor and inhibitory • In vitro characterizations retroviral vector mutant glycoproteins (pro-tumor) neoantigens of production of Research transduction process for using deep mutational are identified Viruses solid cancer scanning • Comprehensive and • Efficacy studies in rodent Steven Feldman, Director of • The libraries can be used flexible system: For any and non-human primate Manufacturing and Process to define the molecular patient, any antigen type, challenge models Development, Stanford Center basis of neutralizing any cancer and both CD8+ Farshad Guirakhoo, CSO, for Cell Therapy (CONFIRMED) antibodies and CD4+ T cells GeoVax (CONFIRMED) Ethan Laudermilch, Post- • Generating Doc, Albert Einstein College unprecedented clinical of Medicine (CONFIRMED) immune response through novel neoantigen vaccine Jessica Baker Flechtner, CSO, Genocea (CONFIRMED)

9:40am Title TBA Reserved for supporting partner. If Approaching Alzheimer’s Reserved for supporting partner. If you Identification and you are interested in being involved, disease as an immunological are interested in being involved, please characterization of KRAS please contact Derek Cavanagh at contact Derek Cavanagh at Marina Udier, CEO, Nouscon [email protected] or disease: role of biomarkers [email protected] or +44 G12V-specific CD4 T cells (CONFIRMED) +44 (0)207 092 1297 • Innate immune (0)207 092 1297 from the blood of a dysregulation causes pancreatic cancer patient chronic inflammation and • We have developed a development of novel HLA-agnostic Alzheimer’s disease approach to neoantigen • Approaching AD as an identification which immunologic disease combines genomic changes the clinical sequencing, strategy in many ways but bioinformatic analysis, perhaps none more and functional assays important than access to • We identified eleven biomarkers dominant CD4 T clones • We have developed a from the blood of a suite of biomarkers (both pancreatic cancer invasive and non-invasive) patient and confirmed that extent beyond specificity, restriction, classical blood minimal epitopes, and inflammatory measures to avidity identify the right patients • These KRAS G12V- and track target specific CD4 TCRs could engagement and be of therapeutic value treatment response to patients with the Christopher (CJ) Barnum, same driver mutation Director of Neuroscience and and HLA haplotype Translational Medicine, Martin Naradikian, INmune Bio (CONFIRMED) Postdoctoral Fellow, La Jolla Institute for Immunology (CONFIRMED) 10:00am Reserved for supporting partner. If Oncolytic adenovirus and Reserved for supporting partner. If you Title TBA Inhibition of filovirus you are interested in being involved, Anti-PD-1 combination are interested in being involved, please infection by host-targeted please contact Derek Cavanagh at contact Derek Cavanagh at [email protected] or therapy for glioblastoma [email protected] or Mayo Pujols, VP, Head of Trojan horse bispecific +44 (0)207 092 1297 • Phase 2 trial update +44 (0)207 092 1297 Global Cell & Gene Technical antibodies • Mechanisms of immune Development & Manufacturing, • Antibodies can inhibit activation Novartis (TBC) filovirus entry by

Matteo Levisetti, Chief blocking viral surface Development Officer, DNAtrix glycoprotein and host (CONFIRMED) cell receptor engagement. • Lysosomal targeting tags increase uptake of antibodies into cells • Engineered anti-filoviral antibodies with lysosomal targeting tags inhibit filovirus entry Ariel Wirchnianski, PhD Candidate, Albert Einstein College of Medicine (CONFIRMED)

10:20am Overview of Neon’s approach Replimune's oncolytic Off-the-shelf, allogeneic T-Cell Presentation available Comprehensive analysis of to the development of immuno-gene therapy: A immunotherapy for patients neutralizing antibodies personalized cancer potent and versatile with progressive Multiple raised against the yellow immunotherapies approach to patient-specific Sclerosis (MS) fever virus vaccine • The recognition of neo- anti-tumor vaccination and • Growing evidence that • First comprehensive antigens on human therapy EBV has a major role in analysis of antibody cancer has strongly been • Replimune is developing the pathogenesis of MS response to yellow fever connected to the clinical its Imulytic family of • Loss of EBV CD8+ T cell vaccine success of immune oncolytic immuno-gene function correlates with • Emergence of highly therapies NEON therapy agents (RP1- MS disease progression potent neutralizing Therapeutics aims to RP3), each of which is in • ATA188 is a novel off-the- antibodies after generate neo-antigen or being prepared for shelf, allogeneic T-cell vaccination over time specific vaccines and T clinical trials alone in immunotherapy targeting • Insights into the capacity cell therapies that are combination PD1 EBV-infected B cells for of the vaccine to protect tailored for each blockade patients with progressive against the emerging individual patient. Here • The core backbone virus MS yellow fever virus strain we will present the (RP1) has been designed AJ Joshi, SVP, Chief Medical in Brazil platform that NEON has to maximize tumor killing, Officer , Atara Biotherapeutics Denise Haslwanter, Research developed to generate the amount of tumor (CONFIRMED) Fellow, Albert Einstein such personal antigen released for College of Medicine vaccination purposes, (CONFIRMED)

neoantigen-specific T cell and the immunogenicity therapies of tumor cell death Marit van Buuren, Lab Head, • This is then further armed Scientist II, Immunology, to deliver potent immune Neon Therapeutics stimulatory protein (CONFIRMED) encoding genes directly to the sites of immune response generation, intended to further augment the systemic anti-tumor immune response generated Robert Coffin, CEO, Replimmune (CONFIRMED) 10:40am Morning networking break Neoantigens Oncolytic Viruses Non-Oncology Immunotherapy

11:15am Expanded neoantigenic payloads and rapid Realizing the full potential of multi-faceted oncolytic Engineering T cells to cure HIV biopsy to treatment personalized viruses • How can CAR T cells be designed to recognize HIV- immunotherapy • Oncolytic viruses are safe and selective tumour specific T cells • DNA based GT-EPIC™ platform addresses lysing therapeutics • How animal models can drive CAR T cell design the three key needs for effectively • Vaccinia based viruses have tremendous coding • Current clinical trial design that is testing CAR T cells targeting neoantigens: capacity to express multiple therapeutic payloads to delay viral rebound • Ability to drive potent and broad T cell • Oncolytic Viruses can be engineered to exploit James Riley, Associate Professor of Microbiology, immune responses; exosome biology University of Pennsylvania (CONFIRMED) • Ability to target a larger number of John Bell, Professor of Medicine, Ottawa Health Reserved for supporting partner. If you are interested in neoantigens in a single formulation; Research Institute (CONFIRMED) being involved, please contact Derek Cavanagh at • Short manufacturing turnaround time [email protected] or +44 (0)207 092 1297 • Discuss leveraging platform regulatory Presentation available and manufacturing advantages to facilitate clinical translation Niranjan Y. Sardesai, Co-Founder, President and CEO, Geneos Therapeutics (CONFIRMED) 11:35am Update from Vaccibody’s clinical trial with PeptiCRAd - a novel oncolytic virus based therapeutic Safety and efficacy results from large-scale gene Therapy the personalized cancer neoantigen vaccine, cancer vaccine for the treatment of solid tumors trial in patients with Leber’s Hereditary Optic VB10.NEO; insight into parameters • PeptiCRAd technology uses highly immunogenic, Neuropathy (LHON) correlating with improved clinical responses next generation oncolytic adenoviruses as

• Inducing a unique CD8-dominated T cell powerful peptide vaccine delivery system to • Reported are two Investigator-Initiated rAAV2-ND4 response by targeting antigens to APC specifically target and treat solid tumors gene therapy Trials conducted in 2011 and 2018. • Clinical updates on the phase I/IIa VB N- • Rapidly adaptable platform-based delivery can Combined are largest-scale and longest-term gene 01 trial in multiple indications accommodate shared tumor antigens or patient- therapy study for LHON patients. • The link between high quality specific neoantigens • Eight-year follow-up data on 9 patients from IIT#1 neoepitopes and anti-tumour efficacy • First-in-human clinical trial of PeptiCRAd in demonstrated long-term safety and durability of gene Agnete Fredriksen, Co-Founder, President combination with checkpoint inhibitor will be therapy. and CSO, Vaccibody (CONFIRMD) started during 2020 • In IIT#2, 63.21% of 106 patients who reached 12 Sari Pesonen, VP, Scientific and Clinical Development, month follow-up had significant BCVA improvement Co-Founder, Valo Therapeutics (CONFIRMED) and there were no SAEs. Su Xiao, CEO, Neuropth (CONFIRMED) Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at [email protected] or +44 (0)207 092 1297 Presentation available 11:55am Engineering tools for cancer immunotherapy Reserved for supporting partner. If you are interested IL-33 in pulmonary inflammation • Discussion of robust, sensitive methods in being involved, please contact Derek Cavanagh at • IL33 is a key regulator of type 2 cytokines and bioengineered constructs for [email protected] or +44 (0)207 092 • I IL33 can regulate non-type 2 pathways identifying tumor-antigen-specific T cell 1297 • Blockade of IL33 has effects on type 2 and non-type 2 populations from patient blood pathways in mouse models of lung disease • Discussion of high throughput tools for Rajita Pappu, Senior Scientist, Genentech (CONFIRMED) pairing the antigen-specificity of a T cell Presentation available with the T cell receptor gene • Discussion of new immunotherapy strategies that enabled by these tools Jim Heath, President and Professor, Institute for Systems Biology (CONFIRMED) 12:05pm Title TBA Virotherapy activating the CD40/4-1BB pathway in Title TBA pancreatic cancer – interim clinical data David Reardon, Clinical Director, Center for • Shaping the tumor microenvironment by CD40/4- Kathryn Austgen, Associate Director, BlueRock Neuro-Oncology, Dana-Farber Cancer 1BB activating virotherapy (preclinical) Therapeutics (CONFIRMED) Institute (CONFIRMED) • Increasing immune activity using local immune Presentation available stimulation in pancreatic cancer patients • Interim clinical response data using LOAd703 in pancreatic cancer Angelica Loskog, CEO, Lokon Pharma (CONFIRMED)

12:25pm Discovery of novel mAbs targeting Solid Systemic delivery and enhanced immunotherapeutic Presentation available Tumor Neoantigens activity with next generation oncolytic vaccinia • An immunogenic cancer vaccine • The next generation of clinical oncolytic demonstrating clinical activity was vaccinia viruses will need to be delivered utilized as a platoform systemically. • Antibodies were screened for tumor • In addition improved targeting of the sensitivity and specificity, as well as anti- immunosuppressive microenvironment will tumor activity be needed. • Selected antibodies were utilized to • Approaches to achieve these goals, while identify tumor Neoantigens maintaining safety and oncolytic activity will Philip Arlen, President & CEO, Precision be discussed Biologics (CONFIRMED) Steve Thorne, Chief Scientific Officer, Western Oncolytics (CONFIRMED) 12:45pm Networking lunch Closing plenary AI and Machine Learning in Immuno-Oncology 1:45pm Song Qinghua, Head of Artificial Intelligence & Analytical Innovation, Kite Pharma (invited) 2:05pm Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at [email protected] or +44 (0)207 092 1297 2:25pm AI applications for drug discovery and development Kefeng (Kevin) Hua, Senior Manager, AI/Machine Learning Development, Bayer (CONFIRMED) 2:45pm Presentation available 3:05pm Chair’s closing remarks 3:10pm Closing remarks from Terrapinn 3:15pm End of conference

Presents…

World Biosimilar Congress USA 2020

2nd–4th March 2020 The Loews, Coronado, San Diego

Advisory board Anna Rose Welch, Chief Editor, Biosimilar Development Cecil Nick, Vice President, PAREXEL Ivo Abraham, Professor, Pharmacy Practice and Science, The University of Arizona Health Sciences James Marttila, Senior Director, Pharmaceutical Formulary and Contract Management, Supply Chain Management, Mayo Clinic Sanjeev Gupta, Senior General Manager & Head of Advanced Biotechnology, IPCA Laboratories

Confirmed speakers Abhijit Barve, Head, Global Clinical Research, Mylan Alex Brill, Resident Fellow, American Enterprise Institute Alvin Luk, CMO and SVP Global Clinical and Medical Affairs, Shanghai Henlius Anna Rose Welch, Chief Editor, Biosimilar Development Annick De Vries, Director Bioanalysis, Sanquin Bernd Liedert, Clinical Development Unit Head, Biosimilars, Sandoz Blake Leitch, Global Head Marketing Biosimilars, Biogen Bracha Timan, Senior Director, Global Bioassays & Technology, Teva Bruce Leicher, Independent Strategic Legal Advisor/Former Senior Vice President and General Counsel, Momenta Pharmaceuticals Cate Lockhart, Executive Director, Biologics and Biosimilar Collective Intelligence Consortium Chad Pettit, Executive Director, Global Value Access & Policy, Biosimilars, Amgen Charles E. Daniels BSPharm, PhD, Associate Dean and Chief Pharmacy Officer, University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Christine Simmon, Executive Director/Senior Vice President, Policy & Strategic Alliances, Biosimilars Council/Association of Accessible Medicines Chrys Kokino, Head, Global Biologics, Mylan Colin C. Edgerton, MD, FACP, FACR, Executive Chairman, Articularis Rheumatology Network Daniel Alvarez, Senior Director, Immunology and Inflammation Development Lead, Biosimilars, Pfizer Dorthe Bartels, Strategic Advisor, AMGROS Elizabeth Johnson, Biologics Coordinator, Allergy Partners P.A. Enrique Seoane-Vazquez, Professor, Chapman University School of Pharmacy & Economics Science Institute Erika Satterwhite, Head of Global Biosimilars Policy, Mylan Fabio Kellett, Director of Biosimilars, Napp Pharmaceuticals Farrah Wong, Senior Director, Commercial Formulary Contracting Strategy, OptumRx

Graham Statt, Assistant Deputy Minister of Health, Pharmaceutical & Supplementary Benefits, Government of Alberta Hans Sauer, Deputy General Counsel, Vice President for Intellectual Property, Biotechnology Innovation Organization Heather Wall, Chief Commercial Officer, CivicaRx Hillel Cohen, Executive Director, Scientific Affairs, Sandoz Huiguo (Forrest) Hu, General Manager, International Business, 3SBio Jocelyn Hii, Head of R&D, Prestige Biopharma Joe Fuhr, Adjunct Professor of Pharmaceutical & Healthcare Business, Widener University Julio Baez, Bioengineering Industrial Advisor, UCSD Katie Verb, Director, Policy and Research, PhRMA Kevin Knopf, Assistant Clinical Professor Medicine/Chairman Hemotology & Oncology, University of California/Highland Hospital Lawrence Hill, CEO, Gan & Lee USA Leah Christl, Executive Director, Global Regulatory and R&D Policy, Amgen Maggie Dolan, Associate Director Market Access EU Biosimilars, Biogen Maria-Céu Machado, Former President, INFARMED Martin Brenner, Senior Vice President, CSO, Pfenex Matthew Harman, Senior Director of Pharmacy, Employers Health Michael Forstner, Chairman of the Pharmacovigilance Working Group, Medicines for Europe Michael Hongwei Xie, Executive Director of Bioassay and Analytical Development, Shanghai Henlius Biotech Inc. Molly Burich, Director, Public Policy: Biosimilars and Reimbursement, Boehringer Ingelheim Mourad Farouk-Rezk, Global Head of Medical (Biosimilars), Biogen Nacer E Hedroug, Director of Quality Improvement, Mylan Nathan Lewis, Associate Professor, Dept Pediatrics and Bioengineering, USCD Ned Pojskic, Leader, Pharmacy & Health Provider Relations, Green Shield Canada Noelle Sunstrom, CEO & Founder, NeuClone Omar Dabbous, Vice President Global HEOR and RWE, AveXis Pam Traxel, Senior Vice President, Alliance Development and Philanthropy, American Cancer Society Cancer Action Network Parastoo Azadi, Technical Director of Analytical Services, Senior Research Scientist, Complex Carbohydrate Research Center, University of Georgia Philip Schneider, International Advisory Board Chair, Alliance for Safe Biologic Medicines Ravi Pherwani, Head of U.S. Oncology Biosimilars, Pfizer Roman Drai, Research & Development Director, GEROPHARM Ross Day, Former Director, Pharmacy Contracting, Vizient Inc. Rustom Mody, Senior Vice President and Head of Research & Development, Lupin Sanjeev Gupta, Senior General Manager & Head of Advanced Biotechnology, IPCA Sameer Awsare, Associate Executive Director, The Permanente Medical Group Sarfaraz Niazi, Adj. Professor of Pharmaceutical Sciences/CEO, University of Illinois/PharmSci Scott Gavura, Director, Provincial Drug Reimbursement Programs, Cancer Care Ontario Scott Liu, CEO, Shanghai Henlius Senior Representative, Amgen Senior Representative, Biocon Sheila Frame, Vice President and Head of Biopharmaceuticals, North America, Sandoz Sofia Oliveira Martins, Professor/Former Board Member, Lisbon University Faculty of Pharmacy /INFARMED Steinar Madsen, Medical Director, Norwegian Medicines Agency Steve Lehrer, Managing Director, SBLehrer LLC Sue Naeyaert, Former VP Global Government Affairs, Policy and Pharmacoeconomics Biosimilars, Fresenius-Kabi SwissBioSim Sundar Ramanan, Vice President & Head, Global Regulatory Affairs, Biocon Timothy Chiu, Pharmacist Evidence Analyst & Strategist in Drug Information Services, Kaiser Permanente

Wayne Winegarden, Senior Fellow, Pacific Research Institute William Han, Former Assistant General Counsel (Patents), GSK

Workshop speakers Steven Corn, Founder and CEO, Metis Advocacy Marjorie Shapiro, Chief, Laboratory of Molecular and Developmental Immunology, Division of Biotechnology Products Research and Review, FDA Mona Chitre, Chief Pharmacy Officer & VP Integrated Clinical Strategy, Excellus BlueCross BlueShield

Day 1 – Monday, March 2nd 2020 7:30am Registration opens 8:30am Conference doors open 9:00am Opening remarks from Terrapinn Opening keynotes Recent policy and the biosimilars industry 9:05am Chair’s opening remarks Anna Rose Welch, Chief Editor, Biosimilar Development (CONFIRMED) 9:10am Erika Satterwhite, Head of Global Biosimilars Policy, Mylan (CONFIRMED) 9:30am An Amgen sponsored fireside chat Leah Christl, Executive Director, Global Regulatory and R&D Policy, Amgen (CONFIRMED) 9:50am Panel discussion: The FDA’s current position on biosimilars and how the industry in the U.S. will move forward

Christine Simmon, Executive Director/Senior Vice President, Policy & Strategic Alliances, Biosimilars Council/Association of Accessible Medicines (CONFIRMED) Sameer Awsare, Associate Executive Director, The Permanente Medical Group (CONFIRMED) Senior Representative, Amgen (CONFIRMED) Senior representative, Axinn (CONFIRMED)

Moderator: Steve Lehrer, Managing Director, SBLehrer LLC (CONFIRMED) 10:30am Networking break 11:30am Plenary roundtable session 6 senior level tables hosted by thought leaders on key issues in the biosimilars industry. Participants are invited to join discussions relevant to their work and the contribute to those that tackle most challenging topics. There will be two rotations and therefore opportunity to join two sessions, each lasting 35 minutes. TABLE 1 TABLE 2 TABLE 3

Educating stakeholders on Opportunities for biosimilars in How stakeholders can improve biosimilars, focussing on HCPs and emerging markets patient access to biosimilars patients Roman Drai, Research & Pam Traxel, Senior VP, Alliance Dorthe Bartels, Strategic Advisor, Development Director, Development and Philanthropy, AMGROS (CONFIRMED) GEROPHARM (CONFIRMED) American Cancer Society Cancer Action Network (CONFIRMED) TABLE 4 TABLE 5

Roundtable available Roundtable available

TABLE 7 TABLE 8 Reserved for supporting partner. If you are interested in Reserved for supporting partner. If you are interested in being involved, please contact Sam Bohan at being involved, please contact Sam Bohan at [email protected] or +44 (0)20 7 092 1040 [email protected] or +44 (0)20 7 092 1040

12:40pm Networking lunch 1:25pm – WORKSHOP SESSION 1:55pm Transitioning to biosimilars: overview from the health plans and payers Farrah Wong, Senior Director, Commercial Formulary Contracting Strategy, OptumRx (CONFIRMED) Scott Gavura, Director, Provincial Drug Reimbursement Programs, Cancer Care Ontario (INVITED)

Moderator: Mona Chitre, Chief Pharmacy Officer & VP Integrated Clinical Strategy, Excellus BlueCross BlueShield (CONFIRMED)

Track 1 Track 2 Market access Biosimilars in healthcare policy Chair: Ross Day, Former Director, Pharmacy Chair: Anna Rose Welch, Chief Editor, Biosimilar Contracting, Vizient Inc. (CONFIRMED) Development (CONFIRMED)

2:00pm Successful uptake of biosimilars in Kaiser Permanente Clinical trials and testing of biosimilars: New FDA • Kaiser Permanente experience with approaches biosimilars • Two levels of testing: in healthy subjects and • How clinician and patient education and in patients – in silico approach to extension of awareness of biosimilars can continue clinical efficacy evolving and contribute to uptake • FDA admission that efficacy studies do not • Future implications for biosimilar market in assure biosimilarity determination. the US Extrapolation of indications negates the clinical efficacy equivalence model Sameer Awsare, Associate Executive Director, The • Ultimately biosimilars will be approved with Permanente Medical Group and Timothy Chiu, no studies in patients. Dilemma for approval Pharmacist Evidence Analyst & Strategist in Drug of interchangeable products administered Information Services, Kaiser Permanente only once? (CONFIRMED) Sarfaraz Niazi, Adj. Professor of Pharmaceutical Sciences/CEO, University of Illinois/PharmSci (CONFIRMED) 2:20pm Legislative efforts to addressing barriers to biosimilars adoption and/or increasing biosimilars utilization, including: • Exclusivity provisions in global trade agreements • Manufacturer access to reference product samples Reserved for supporting partner. If you are interested in • Increasing provider reimbursement and being involved, please contact Sam Bohan at potential to “share savings” with providers [email protected] or +44 (0)20 7 092 1040 that prescribe biosimilars • Ensuring appropriate formulary placement of biosimilars

Christine Simmon, Executive Director/Senior Vice President, Policy & Strategic Alliances, Biosimilars Council/Association of Accessible Medicines (CONFIRMED) 2:40pm Trends in biosimilar approvals in the EMA/FDA and Biosimilars: the Canadian experience effects of biosimilars on US biologic prices • Biosimilars have been approved in Canada • Describing the effect of biosimilar since 2014, yet the adoption by clinicians and competition on biologic prices in the US, payers continues to lag behind expectations • Discussing how biosimilar competition • Recent initiatives to prefer biosimilars by reduces the growth in prices of reference provincial government are starting to take biologics, and effect, albeit slowly • Presenting trends in biologic and biosimilar • This session will explore the experiences of products authorizations in the US and the one Canadian private insurer and the unique European Union approach it took to driving biosimilar

adoption. The results of a mandatory

Enrique Seoane-Vazquez, Professor, Chapman biosimilar transition policy for patients on University School of Pharmacy & Economics Science etanercept and infliximab will be discussed Institute (CONFIRMED) Ned Pojskic, Leader, Pharmacy & Health Provider Relations, Green Shield Canada (CONFIRMED) 3:00pm Anti-competitive deterrents to investment and Interchangeability designation in the U.S., from law innovation in biosimilars and interchangeable to regulatory to program design guidance via science biologics • Discuss the intent and purpose of the • What are the barriers? interchangeability designation in the U.S. • Is regulatory policy mitigating or creating • Discuss how the FDA guidance integrates the barriers to market access? science to comply with the U.S. statute • Are incumbent market practices that deter • Discuss alternatives to clinical development access being addressed? to attain the interchangeability designation in • What has changed in the last 12 months? the U.S.

Bruce Leicher, Attorney and Former Senior VP and Daniel Alvarez, Senior Director, Immunology and General Counsel, Momenta Pharmaceuticals Inflammation Development Lead, (CONFIRMED) Biosimilars, Pfizer (CONFIRMED) 3:20pm Afternoon refreshments 3:30pm – WORKSHOP SESSION 4:00pm Draft guidance development of therapeutic protein biosimilars: comparative analytical assessment and other quality-related considerations

Marjorie Shapiro, Chief, Laboratory of Molecular and Developmental Immunology, Division of Biotechnology Products Research and Review, FDA (CONFIRMED) 4:10pm The biosimilars strategy in Denmark’s healthcare Favourable changes in biosimilar policy system; how the U.S. can learn from this journey • Aligning incentives to encourage biosimilar • Learnings from the first biosimilar uptake, some examples from Europe. introduction in Denmark • What works and what doesn't • Set-up of a biosimilar task force • Why government institutions need to get involved because of market failure Dorthe Bartels, Strategic Advisor, AMGROS (CONFIRMED) Sue Naeyaert, Former VP Global Government Affairs, Policy and Pharmacoeconomics Biosimilars, Fresenius- Kabi SwissBioSim (CONFIRMED) 4:30pm An overview on Canadian cross-province experiences Interchangeability – an industry perspective on the implementing a biosimilar strategy role and value for stakeholders • Existing interchangeability requirements Graham Statt, Assistant Deputy Minister of Health, • Understanding the role of interchangeability Pharmaceutical & Supplementary Benefits, and automatic substitution, and how this Government of Alberta, and Scott Gavura, Director, could impact biosimilar uptake Provincial Drug Reimbursement Programs, Cancer • Assessing the value of interchangeability by Care Ontario (CONFIRMED) key stakeholder

Molly Burich, Director, Public Policy: Biosimilars and Reimbursement, Boehringer Ingelheim (CONFIRMED) 4:50pm Key considerations to achieving biosimilar success in Panel discussion: What do policymakers need to emerging markets: affordability and access; regional address for biosimilars to become more accessible? systemic complexities; and awareness

• Developing low-cost approaches to reducing Katie Verb, Director, Policy and Research, PhRMA costs; innovating payment structures; (CONFIRMED) choosing the right portfolio (studying payer, Kevin Knopf, Assistant Clinical Professor patient and physician needs); and Medicine/Chairman Hemotology & Oncology, participating in policy making to develop University of California/Highland Hospital infrastructure and support (CONFIRMED) • Partnering locally for commercialization (from Leah Christl, Executive Director, Global Regulatory and manufacturing to sales) – custom approaches R&D Policy, Amgen (CONFIRMED) required for each market/sub-market Ned Pojskic, Leader, Pharmacy & Health Provider • Patient and physician awareness – both about Relations, Green Shield Canada (CONFIRMED) biologics and switching to biosimilars – needs Steven Corn, Founder and CEO, Metis Advocacy to be handled carefully (CONFIRMED)

Steve Lehrer, Managing Director, SBLehrer LLC Moderator: Philip Schneider, International Advisory (CONFIRMED) Board Chair, Alliance for Safe Biologic Medicines 5:10pm The first Trastuzumab biosimilar manufactured in (CONFIRMED) China and developed for global approval • Comparison of NMPA and EMA guidelines for the development of biosimilars • Choice of sourcing the reference product • Summary of the Trastuzumab biosimilar, HLX02 – analytical characterization, non- clinical and clinical studies • Post-marketing pharmacovigilance requirements between NMPA and EMA

Alvin Luk, CMO and SVP Global Clinical and Medical Affairs, Shanghai Henlius (CONFIRMED) 5:30pm Offsite drinks reception

Day 2 – Tuesday, March 3rd 2020 8:00am Registration opens 8:30am Conference doors open Day 2 keynotes Building a sustainable biosimilar industry 8:45am Chair’s opening remarks Maggie Dolan, Associate Director Market Access EU Biosimilars, Biogen (CONFIRMED) 8:50am The evolution of the US biosimilars market • Approval vs launches, and gradual market uptake of the different marketed biosimilars • Changing perceptions of physicians and payers • Opportunities to support the US biosimilars market

Sheila Frame, Vice President and Head of Biopharmaceuticals, North America, Sandoz (CONFIRMED) 9:10am Reserved for supporting partner. If you are interested in being involved, please contact Sam Bohan at [email protected] or +44 (0)20 7 092 1040 9:30am Michael Soldan, Executive Vice President, Head of Biosimilars, Fresenius Kabi (INVITED) 9:50am Panel discussion: How to build a sustainable biosimilar market • How to achieve sustainable uptake (a European perspective) • How successful has biosimilar uptake been so far in the U.S.? • How can we ensure this market is sustainable in the future?

Chad Pettit, Executive Director, Global Value Access & Policy, Biosimilars, Amgen (CONFIRMED) Fabio Kellett, Director of Biosimilars, Napp Pharmaceuticals (CONFIRMED) Sheila Frame, VP and Head, North America, Biopharmaceuticals, Sandoz (CONFIRMED) Elizabeth Jex, Attorney Advisor, Office of Policy Planning, Federal Trade Commission (INVITED)

Moderator: Maggie Dolan, Associate Director Market Access EU Biosimilars, Biogen (CONFIRMED) 10:25am Networking break 10:30am – WORKSHOP SESSION 11:15am What the industry can do to make the patient healthcare experience better • Results from patient survey on healthcare in the U.S. • Impact on rising healthcare costs that biologics cause

Steven Corn, Founder and CEO, Metis Advocacy (CONFIRMED) Track 1 Track 2 The clinical environment and real-world evidence Biosimilars in healthcare policy Chair: Hillel Cohen, Executive Director, Scientific Chair: Philip Schneider, International Advisory Board Affairs, Sandoz (CONFIRMED) Chair, Alliance for Safe Biologic Medicines (CONFIRMED) 11:25am Current state of biosimilars in the U.S. and the role of Do biosimilars create real competition? real-world evidence in overcoming barriers to • The economics of biosimilars is as complex utilization and as important as that of innovator • The current status of biosimilar availability biologics. Biosimilars are costly and risky and utilization in the U.S. ventures and without a return, will not be • The barriers to access and utilization of pursued biosimilars in the U.S. from multiple • The U.S. market is developing, albeit more stakeholder perspectives, including patients, slowly than originally anticipated by most healthcare providers, payers, and health experts. Current evidence indicates that systems biosimilars are gaining market share and • Define real-world evidence and discuss how it delivering cost savings to the system may be interpreted and used in making • Arguments of a "natural monopoly" do not treatment and coverage decisions withstand scrutiny and policymakers should instead pursue efforts to further encourage Cate Lockhart, Executive Director, Biologics and competition in this nascent market Biosimilar Collective Intelligence Consortium (CONFIRMED) Alex Brill, Resident Fellow, American Enterprise Institute (CONFIRMED) 11:45am Supporting biosimilar acceptance by giving clinicians and patients control using routine diagnostic serum concentration measurements for biologics/biosimilars – real-world data • Experience from routine diagnostics on concentration and ADA measurements Reserved for supporting partner. If you are interested in • One dose/ multitude of serum levels; impact being involved, please contact Sam Bohan at of immunogenicity on PK [email protected] or +44 (0)20 7 092 1040 • Validation of PK/ADA assays for originators for biosimilars; routine diagnostics vs. FDA/EMA registration

Annick De Vries, Director Bioanalysis, Sanquin (CONFIRMED)

12:05pm Real-world evidence for benefit-risk decision making: Reimbursement in biosimilars quality and acceptability criteria for different • Current reimbursement landscape for stakeholders biosimilars • How do you evaluate and demonstrate real- • Why not to throw in the towel in biosimilars world data and evidence quality? creating competition • How can you select appropriate real-world • The road ahead for biosimilars and data sources? reimbursement • What are important aspects of real-world data relevancy and quality for regulatory- Katie Verb, Director, Policy and grade decision making? Research, PhRMA (CONFIRMED)

Michael Forstner, Chairman of the Pharmacovigilance Working Group, Medicines for Europe (CONFIRMED) 12:25pm The role of biosimilars in addressing unmet medical Originator and biosimilar: getting the balance right needs in immune mediated inflammatory diseases • The U.S. biologics sector is excelling at (IMID): creating new originator biologic medicines • Immune mediated inflammatory diseases are that provide patients with new innovative generally undertreated medicines. Developing a robust competitive • Biosimilars have already helped market via biosimilars is a different story the healthcare systems to realize major • Biosimilars offer a tremendous savings savings and hence offered headroom for opportunity by fostering this needed funding innovation competitive market. Addressing key market • On top of the cost savings, anti-TNFs and policy obstacles can help create a more biosimilars should be leveraged to advance robust and viable competitive market saving the management of IMID with an earlier, the U.S. health care sector billions of dollars optimized and sustainable control Wayne Winegarden, Senior Fellow, Pacific Research Mourad Farouk-Rezk, Global Head of Medical Institute (CONFIRMED) (Biosimilars), Biogen (CONFIRMED) 12:45pm Networking lunch 1:25pm – WORKSHOP SESSION 1:55pm How can employers promote biosimilar adoption? • Biosimilars from an employer’s perspective • Employer strategies to promote biosimilars

Matthew Harman, Senior Director of Pharmacy, Employers Health (CONFIRMED) Track 1 Track 2 The clinical environment and real-world evidence Commercialization and sustainability Chair: Hillel Cohen, Executive Director, Scientific Chair: Blake Leitch, Global Head Marketing Affairs, Sandoz (CONFIRMED) Biosimilars, Biogen (CONFIRMED)

2:00pm Importance of successful commercialization of Final title TBC biosimilars to hospitals • Hospitals have experienced unusual Ravi Pherwani, Head of U.S. Oncology Biosimilars, pharmaceutical price increases since 2014 Pfizer (CONFIRMED) • Explosive growth has been observed in treatments for hep-C, MS, diabetes and cancer which require specialty pharmaceuticals, pharmacies and distributors, accounting for ~50% of a typical hospital’s spend

• Very few life-cycle opportunities in the small molecule environment compared to 2011- 2012 and the impact of life-cycle opportunities in the large molecule environment of today are limited

Ross Day, Former Director, Pharmacy Contracting, Vizient Inc. (CONFIRMED) 2:20pm Sustainability of biosimilars in Europe, with a focus on four EU countries • What is supposed to be the role of biosimilars? • The European reality of biosimilars • Successful measures to increase the use of Reserved for supporting partner. If you are interested in biosimilars being involved, please contact Sam Bohan at [email protected] or +44 (0)20 7 092 1040 • The role of biosimilars in the sustainability of health systems

Maria-ceu Machado, Former President, INFARMED (CONFIRMED) and Sofia Oliveira Martins, Professor/Former Board Member, Lisbon University Faculty of Pharmacy/INFARMED (CONFIRMED) 2:40pm Application in the U.S. healthcare system market: introducing biosimilars to the formulary • A pharmacist’s look at the biosimilar product • The health system’s look at placing biosimilars Reserved for supporting partner. If you are interested in • Collaboration to incorporate biosimilar being involved, please contact Sam Bohan at agents [email protected] or +44 (0)20 7 092 1040

Charles E. Daniels BSPharm, PhD, Associate Dean and Chief Pharmacy Officer, University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences (CONFIRMED) 3:00pm Social media influence over patients in the Affordability of biosimilars (final title TBC) biologic/biosimilar market • Patient "influencers" sponsored by various Scott Liu, CEO, Shanhai Henlius (CONFIRMED) companies and organizations appeal to patients on social media platforms • This can be encouraging or discouraging, hurting the promotion of biosimilars, one example is a GI group that fights hard against Infliximab, a biosimilar of Remicade

Elizabeth Johnson, Biologics Coordinator, Allergy Partners P.A. (CONFIRMED) 3:20pm Afternoon refreshments 4:00pm Cost savings by use of biosimilars at a county Challenges and opportunities for biosimilar hospital businesses in emerging markets • Cancer care economics in the public/not-for- • The main challenges in emerging markets profit sector is a proper use case for cost- • Cooperative synergy makes long-term opportunities

effectiveness to ensure health equity and • New environment and opportunities in quality of care the Chinese market • A program of 100% switching to biosimilars in our public hospital was implemented and Huiguo (Forrest) Hu, General Manager, International resulted in significant cost savings Business, 3SBio (CONFIRMED) • This approach can be scaled to other public/county hospitals

Kevin Knopf, Assistant Clinical Professor Medicine/Chairman Hemotology & Oncology, University of California/Highland Hospital (CONFIRMED) 4:20pm Value-based treatment pathways in rheumatoid Lessons from a non-profit generics producer – arthritis understanding the drivers and the strategies that • Understand clinical and contracting barriers lead to U. S. health system internal disruption to the use of biosimilar agents in • As a health-system driven “start-up”, the rheumatology disruption and innovation that is being put • Review the utility of a value-based treatment into place is identified at the point of care pathway for RA • The expected outcome of the disruption and • Understand how treatment pathways can be innovation is seamless availability of generic leveraged by providers to increase access to medications at a sustainable price point to biosimilar agents in rheumatology meet patient need

Colin C. Edgerton, MD, FACP, FACR, Executive Heather Wall, Chief Commercial Officer, CivicaRx Chairman, Articularis Rheumatology Network (CONFIRMED) (CONFIRMED) 4:40pm Panel discussion: Clinical trials and RWE. How Orphan drug biosimilars: when a copy could cost important is RWE in differentiating between more than the innovator competing biosimilars? How does real-world data • Different roles of original drugs and influence physicians? biosimilars on the market • Clinical development programs of originator Charles Daniels, Associate Dean and Chief Pharmacy vs biosimilar. What’s the difference? Officer, University of California San Diego, Skaggs • Problems for orphan drug biosimilars School of Pharmacy and Pharmaceutical Sciences • Ways of overcoming obstacles (CONFIRMED) Elizabeth Johnson, Biologics Coordinator, Allergy Roman Drai, Research & Development Director, Partners P.A. (CONFIRMED) GEROPHARM (CONFIRMED) 5:00pm Kevin Knopf, Assistant Clinical Professor The value and affordability of orphan drugs Medicine/Chairman Hemotology & Oncology, • Evaluating the value of orphan drugs University of California/Highland Hospital • How we can pay for orphan drugs and (CONFIRMED) whether it’s feasible for biosimilar producers Pradeep Nair, Associate Director, Oncology and to improve their affordability Biosimilars, Teva Canada Innovation (INVITED) John Kelton, Medical Director - Oncology Biosimilars, Omar Dabbous, Vice President Global HEOR and RWE, Pfizer (INVITED) AveXis (CONFIRMED)

Moderator: Cate Lockhart, Executive Director, Biologics and Biosimilar Collective Intelligence Consortium (CONFIRMED)

5:20pm Networking drinks and poster presentation session

Day 3 – Wednesday, March 4th 2020 8:30am Registration opens 9:00am Conference doors open Track 1 Track 2 Development, manufacturing and analysis IP and legal challenges Chair: Julio Baez, Bioengineering Industrial Advisor, Chair: Bruce Leicher, Independent Strategic Legal UCSD (CONFIRMED) Advisor/Former Senior Vice President and General Counsel, Momenta Pharmaceuticals (CONFIRMED)

9:05am A case study on utilizing an existing molecule (full Proposed and pending federal title TBC) legislation affecting biosimilars • Improvements to the “patent dance” Martin Brenner, Senior Vice President, CSO, Pfenex • Expanding anti- “product hopping” proposals (CONFIRMED) to biosimilars • Patent listing in the Purple Book • Presumptive patent term disclaimer

Hans Sauer, Deputy General Counsel, Vice President for Intellectual Property, Biotechnology Innovation Organization (CONFIRMED) 9:25am The pitfalls of biosimilar characterization and how to overcome them • What are the issues with excipients? • Lot numbers of innovator products • Pros and cons of methodologies such as NMR and MS, and validation of methods and time Reserved for Axinn frame

Parastoo Azadi, Technical Director of Analytical Services, Senior Research Scientist, Complex Carbohydrate Research Center, University of Georgia (CONFIRMED) 09:45am Reserved for supporting partner. If you are interested in William Han, Former Assistant General Counsel being involved, please contact Sam Bohan at (Patents), GSK (CONFIRMED) [email protected] or +44 (0)20 7 092 1040 10:05am Biosimilarity assessment using functional and binding assays – challenges and insights • Challenges in defining product Critical Quality Attributes (CQA) to determine the Quality Target Product Profile (QTPP) • Statistical approaches for similarity Reserved for supporting partner. If you are interested in assessments – how many reference product being involved, please contact Sam Bohan at lots should be sufficient [email protected] or +44 (0)20 7 092 1040 • Similarity assessment of monoclonal therapeutic drug using functional and binding attributes – challenges and insights

Bracha Timan, Senior Director, Global Bioassays & Technology, Teva (CONFIRMED)

10:25am Difficult to express antibodies – problems and Christopher Robertson, Professor of Law, Associate resolutions Dean for Research & Innovation, University of Arizona • NeuClone biosimilar development – School of Law (INVITED) delivering high-quality, low-cost biosimilars at scale with a pure focus on biosimilar monoclonal antibody development • Over 25 biosimilar monoclonal antibodies in active development o Difficult to express antibodies – expression vector constructs o Difficult to express antibodies - expression in CHO-K1 vs. CHO-S o Difficult to express antibodies – transfection protocols

Noelle Sunstrom, CEO & Founder, NeuClone (CONFIRMED) 10:45am Networking break Track 1 Track 2 Development, manufacturing and analysis Insulin biosimilars Chair: Julio Baez, Bioengineering Industrial Advisor, Chair: Ann Kempski, Strategic Advisor, National UCSD (CONFIRMED) Coalition on Healthcare (INVITED) 11:15am Biosimilarity of HD201 (Tuznue®), a Trastuzumab Comparing the regulatory challenges for insulin biosimilar from analytical similarity assessment to biosimilars between China and the US/EU clinical equivalence • Looking at China through new eyes • Major differences in registering in China, US, Jocelyn Hii, Head of R&D, Prestige Biopharma EU (CONFIRMED) • Recent changes in China regulatory approaches

Lawrence Hill, CEO, Gan & Lee USA (CONFIRMED) 11:35am Next generation biosimilars Reserved for supporting partner. If you are interested in Senior Representative, Biocon (CONFIRMED) being involved, please contact Sam Bohan at [email protected] or +44 (0)20 7 092 1040

11:55am Insulin biosimilars (full title TBC) Reserved for supporting partner. If you are interested in being involved, please contact Sam Bohan at Chrys Kokino, Head, Global Biologics, Mylan [email protected] or +44 (0)20 7 092 1040 (CONFIRMED) and Abhijit Barve, Head, Global Clinical Research, Mylan (CONFIRMED) 12:05pm Lowering the cost of biosimilars with new technology Panel discussion: Insulin biosimilars and how they • Contribution of clone and process (R&D) on can improve access for diabetes patients lowering manufacturing costs • Continuous evaluation and implementation Lawrence Hill, CEO, Gan & Lee USA (CONFIRMED) of novel technologies both in R&D and Mona Chitre, Chief Pharmacy Officer & VP Integrated manufacturing Clinical Strategy, Excellus BlueCross BlueShield • Strategy for developing manufacturing (CONFIRMED) capabilities to save running costs Sarfaraz Niazi, Adj. Professor of Pharmaceutical • Role of automation and QbD approach to Sciences/CEO, University of Illinois/PharmSci developing affordable biosimilars (CONFIRMED)

Sundar Ramanan, Vice President & Head, Global Sanjeev Gupta, Senior General Manager & Head of Regulatory Affairs, Biocon (CONFIRMED) Advanced Biotechnology, IPCA (CONFIRMED) Chrys Kokino, Head Global Biologics, Mylan (INVITED) Krista Maier, Vice President of Public Policy & Strategic Alliances, American Diabetes Association (INVITED)

Moderator: TBC

12:25pm Big data and predictive glycoengineering • Glycosylation is complex and difficult to control on biologics • Development of big data analytics has been achieved to understand factors associated with glycosylation • Models and algorithms predict how one may achieve desired glycosylation

Nathan Lewis, Associate Professor, Dept Pediatrics and Bioengineering, USCD (CONFIRMED) 12:45pm Networking lunch Track 1 Development, manufacturing and analysis Chair: Julio Baez, Bioengineering Industrial Advisor, UCSD (CONFIRMED) 1:40pm Streamlining process development to achieve maximum efficiency with minimum cost and time • Lineally scalable equipment during scale-up helps to maintain CQAs • Having the right clone (that gives biosimilar products) improves process efficiency • Methods to control process-borne enzymes, such as proteases, sialidases and deglycosylases help to prevent target-product modifications

Rustom Mody, Senior Vice President and Head of Research & Development, Lupin (CONFIRMED) 2:00pm Analytical similarity studies and the first biosimilar monoclonal antibody in China • QbD-based quality study and determination of critical quality attributes (CQAs) of biosimilar mAbs following a developed quality study platform at Henlius and analytical similarity study of biosimilar mAbs and the corresponding regulatory requirements in China and abroad • Presentation of some major results of analytical similarity study on the 1st China biosimilar mAb Hanlikang® (Henlius rituximab biosimilar HLX01 to the MabThera®) • Presentation and discussion of some major analytical similarity study points for Henlius biosimilar HLX02 (a trastuzumab biosimilar to Herceptin®), made both NMPA NDA and EMA MAA filings in 2019

Michael Hongwei Xie, Executive Director of Bioassay and Analytical Development, Shanghai Henlius Biotech Inc. (CONFIRMED) 2:20pm QA controls and operations: Validation qualification and regulatory

Nacer E Hedroug, Director of Quality Improvement, Mylan (CONFIRMED) 2:40pm Progress in expression systems to reduce cost and improve product quality • Use of improved performance expression systems to reduce costs and development time while improving productivity and product quality • The implementation of novel and improved performance expression systems to meet needs of different regions

• Integrated progress in bioanalytics and downstream processing to implement improved performance expression systems

Julio Baez, Bioengineering Industrial Advisor, UCSD (CONFIRMED) 3:00pm Closing remarks from the chairs

3:10pm Closing remarks from Terrapinn

3:15pm End of conference

Festival of Biologics USA - Workshop agenda

Day 1 - Monday March 2nd 2020 Conference sessions 12:45pm Identifying early stage assets in academia ANTIBODIES: Comparing strategies and challenges of – 1:20pm • Technology Transfer databases – Identifying bispecific antibody infusion Potential Drug Discovery Programs • What is an ideal bispecific antibody for different • In-licensing expectations approaches? • Academic advisory roles • What's the pathophysiology of side effects related to • Establishing a firewall for intellectual property different routes of delivery of bispecific antibody rights infusions? • What are the advantages and disadvantages of Marc Nasoff, Chief Scientific Officer, Fortis Therapeutics different approaches using bispecific antibodies? (CONFIRMED) • What are the challenges preventing clinical effectiveness using the various platforms?

Larry Lum, Professor, Director of Cellular Therapy, Scientific Director of Bone Marrow Transplant, University of Virginia (CONFIRMED) 1:25pm – ANTIBODIES: AI for antibody drug discovery and BIOSIMILARS: Transitioning to biosimilars: overview 1:55pm development from the health plans and payers • An overview of how AI is currently used for in silico antibody discovery and development Farrah Wong, Senior Director, Commercial Formulary • Real life examples of how this is currently used, Contracting Strategy, OptumRx (CONFIRMED) with challenges and case studies Scott Gavura, Director, Provincial Drug Reimbursement • Workshop on how AI can be implemented into Programs, Cancer Care Ontario (INVITED) the antibody industry

Stanley Krystek, Research Fellow, Bristol Myers-Squibb Moderator: Mona Chitre, Chief Pharmacy Officer & VP (invited) Integrated Clinical Strategy, Excellus BlueCross BlueShield Bojana Popovic, Senior Research Scientist, MedImmune (CONFIRMED) (invited) Conference sessions 3:30pm – ANTIBODIES: Overview of therapeutic protein BIOSIMILARS. Draft guidance development of 4:00pm immunogenicity workshop therapeutic protein biosimilars: comparative analytical assessment and other quality-related considerations Jack Ragheb, Senior Medical Fellow, Immunology, Eli Lilly & Company (CONFIRMED) Marjorie Shapiro, Chief, Laboratory of Molecular and Andrea Ferrante, Principal Research Scientist, Eli Lilly Developmental Immunology, Division of Biotechnology and Company (CONFIRMED) Products Research and Review, FDA (CONFIRMED) Arunan Kaliyaperumal, Research Fellow, Eli Lilly and Company (CONFIRMED) Conference sessions Day 2 - Tuesday March 3rd 2020 Conference sessions 10:30am BIOSIMILARS: What the industry can do to make the CLINICAL TRIALS: Operationalizing pediatric and adult – patient healthcare experience better cell therapy trials 11:15am • Results from patient survey on healthcare in the US Brenda Hann, Director, Clinical Trials Operations, • Impact of biologics on rising healthcare costs Stanford Medicine (CONFIRMED) Janet McDowell, Clinical Research Manager, Stanford Steven Corn, Founder and CEO, Metis Advocacy University School of Medicine - Cancer Clinical Trials (CONFIRMED) Office (CONFIRMED) Theresa Latchford, Oncology Clinical Nurse Specialist, Stanford Health Care - Blood and Marrow Transplant Unit (CONFIRMED) Anne Cunniffe Marcy, Clinical Research Coordinator, Stanford University School of Medicine - Cancer Clinical Trials Office (CONFIRMED) Conference sessions 12:50pm Biologics investor clinic CLINICAL TRIALS: Panel discussion: patients as partners – 1:20pm • Workshop focusing on investing in biologics in clinical development • Which biologics are hot now, what are people • How can we collaborate more with patients? investing in? • Improving transparency • What makes a biologic investable? • Public awareness of clinical trials

Kevin Johnson, Partner, Medixci (CONFIRMED) Moderator: Julie Gerberding, Executive Vice President, John Hood, Chairman, Endeavour Biomedicines Communications, Global Policy, and Population Health & (CONFIRMED) Chief Patient Officer, Merck (CONFIRMED) Stan Fleming, Founding Managing Partner, Forward Eve Bukowski, Vice President, Patient Advocacy, Ventures (CONFIRMED) Education & Outreach, California Life Sciences 1:25pm – BIOSIMILARS: How can employers promote biosimilar Association (CLSA) (CONFIRMED) 1:55pm adoption? Other speakers TBA • Biosimilars from an employer’s perspective • Employer strategies to promote biosimilars

Matthew Harman, Senior Director of Pharmacy, Employers Health (CONFIRMED) Conference sessions

3:25pm – Workshop TBA CLINICAL TRIALS: Title TBA 3:55pm Amrit Takhar, GP Partner and Clinical Lead, Wansford surgery – NHS (CONFIRMED) Conference sessions