DOCSLIB.ORG

Irp180426-A.Pdf

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Irp180426-A.Pdf Roche Q1 2018 results Basel, 26 April 2018 This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected. 3 Group Severin Schwan Chief Executive Officer Q1 2018: Strong sales growth in both divisions 2018 2017 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 10.7 10.2 5 7 Diagnostics Division 2.9 2.8 5 5 Roche Group 13.6 12.9 5 6 CER=Constant Exchange Rates 5 Q1 2018: Sales growth for the seventh consecutive year 10% 8% 8% 7% 7% 6% 6% 6% 6% 6% 6% 6% 6% 6% 6% 5% 5% 5% 5% 4% 4% 4% 4% 4% 4% 4% 3% 3% 2% 2% 0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 12 12 12 12 13 13 13 13 14 14 14 14 15 15 15 15 16 16 16 16 17 17 17 17 18 All growth rates at Constant Exchange Rates (CER) 6 Q1 2018: Strong sales growth in US and International CHFbn 7 +14% 6 +8% 5 4 +6% -5% Diagnostics 3 +15% Pharma +9% -1% 2 0% +5% -7% 1 -8% 0% 0 Japan International Europe US All growth rates at Constant Exchange Rates (CER) 7 Roche significantly advancing patient care, BTD’s reflecting the quality of our research Phase duration (years) No = 7.5 Fast track = 5.8 Accelerated review = 3.8 Breakthrough therapy = 3.6 8 2018: New products with annualized sales of >CHF 8bn* ~80% of growth driven by new products * Venclexta sales are booked by partner AbbVie. 9 Replace and extend the business Through continuously improving standard of care Entering new Replace existing businesses Achievements Q1 2018 franchises Gazyva, Perjeta: Launched in eBC in US Venclexta, MabThera MS: polatuzumab vedotin, Ocrevus Gazyva: Launched in FL in US/EU Sub Cut Hemlibra: Launched in inh. patients in US/EU; BTD in non-inh. Perjeta, Herceptin Kadcyla, Tecentriq: IMpower150 with OS benefit Sub Cut Hemophilia: Venclexta: Launched in 17p del; Filed in CLL R/R Hemlibra Tecentriq, Avastin baloxavir: Filing initiated in US entrectinib entrectinib: Acquisition of Ignyta completed VA2, Lucentis port delivery CNS: VA2: Strong Ph II data in DME SMA, Autism, Tamiflu baloxavir (Cap Endo) Huntington’s VA2=anti-VEGF/anti-angiopoietin-2 bispecific antibody; MS=multiple sclerosis; SMA=spinal muscular atrophy; eBC=early breast cancer; FL=follicular lymphoma; BTD=Breakthrough 10 Therapy Designation; CLL R/R=relapsed/refractory (R/R) chronic lymphocytic leukemia; DME=diabetic macular edema Record number of NMEs at pivotal stage Q1 entrants: Anti-VEGF/Ang2 biMAb, entrectinib, baloxavir marboxil Oncology Ophthalmology Neuroscience Immunology Infectious Disease NME=new molecular entities; For details on the indications and line extensions please consult the pipeline appendix. Cap Endonuclease inhibitor (baloxavir marboxil) 11 2018 outlook raised From “stable to low single digit” to “low single digit” Group sales growth1 • Low-single digit • Broadly in line with sales, excl. US tax reform benefit Core EPS growth1 • High-single digit, incl. US tax reform benefit Dividend outlook • Further increase dividend in Swiss francs 1 Sales growth at Constant Exchange Rates (CER) 12 Pharmaceuticals Division Daniel O’Day CEO Roche Pharmaceuticals 13 Q1 2018 performance Innovation Outlook 14 Q1 2018: Pharma sales Accelerated growth in US due to new products 2018 2017 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 10,672 10,177 5 7 United States 5,516 5,070 9 15 Europe 2,287 2,273 1 -7 Japan 851 856 -1 0 International 2,018 1,978 2 5 CER=Constant Exchange Rates 15 Q1 2018: New products with strong momentum, out growing biosimilar onset Absolute values and growth rates at Constant Exchange Rates (CER) 16 Q1 2018: Oncology sales stable YoY CER growth Perjeta • Perjeta: Strong growth in all regions; US momentum due to early APHINITY approval HER2 Herceptin +6% • Kadcyla: Growth driven by International Kadcyla • EU: Decline largely due to price cut in France Avastin -2% • US/EU: 1L lung cancer shares stable after CIT entry Gazyva/Gazyvaro Hematology MabThera/Rituxan • US/EU: Good initial uptake of Gazyva in 1L FL in the early launch countries (Oncology) -7% Tarceva -32% • Increased competition • EU: Launch in lung (2/3L) and bladder (2L and 1L cisplatin ineligible) ongoing Tecentriq +29% • US: 2L lung cancer and 1L cisplatin ineligible bladder shares stable • US: 1L new patient market share of >50% achieved following 1L approval in Q4 Alecensa +81% • EU: Strong 1L launch in key markets Cotellic Cotellic + -6% • EU: Increasing competition from CIT Zelboraf CHFbn 0 1 2 3 Q1 2018 Oncology sales: CHF 6.4bn (CER growth 0%); All growth rates at Constant Exchange Rates (CER); CIT=cancer immunotherapy; FL=follicular lymphoma 17 Her2 franchise: Growth driven by Perjeta CHFm YoY CER growth 3,000 +6% +6% Her2 franchise Q1 2018 2,500 +9% +23% • Perjeta US (+18%): Accelerated growth driven by eBC following approval in the adjuvant setting (APHINITY) 2,000 • Perjeta in eBC on NCCN, St. Gallen, and AGO (Germany) 1,500 guidelines Outlook 2018 1,000 • US: Continued Perjeta uptake in eBC 500 • EU: Approval in adjuvant BC (APHINITY) • EU: Market entry of Herceptin biosimilars 0 Q1 15 Q1 16 Q1 17 Q1 18 Herceptin Perjeta Kadcyla CER=Constant Exchange Rates; eBC=early breast cancer; NCCN=National Comprehensive Cancer Network; AGO=Arbeitsgemeinschaft Gynäkologische Onkologie 18 Hematology: Entering the rejuvenation phase CHFm YoY CER growth Hematology Q1 2018 2,000 CD20 franchise • MabThera (onc) US (+2%): Stable volumes in all indications +4% +5% +3% • MabThera (onc) EU (-43%): Biosimilar roll-out ongoing 1,500 -7% • Gazyva (+27%): Growth driven by 1L FL early launches Venclexta* 1,000 • Venclexta sales reached USD 59m (+179%) with ~40% patient share reached in R/R CLL with 17p deletion 500 Outlook 2018 • US: first biosimilar entry in H2 expected • US/EU approval Venclexta + Rituxan in R/R CLL (MURANO) 0 • Ph II data for Polatuzumab vedotin + BR in R/R DLBCL to be Q1 15 Q1 16 Q1 17 Q1 18 shared with health authorities MabThera/Rituxan (Onc) Gazyva/Gazyvaro CER=Constant Exchange Rates; FL=follicular lymphoma; CLL=chronic lymphoid leukemia; BR=bendamustine+Rituxan; DLBCL=diffuse large B-cell lymphoma; * Venclexta sales are 19 booked by partner AbbVie. Alecensa: US market leadership in 1L ALK+ NSCLC achieved CHFm YoY CER growth Alecensa Q1 2018 150 • US: New patient share of >50% in first quarter of launch +81% 125 • Launch supported by FMI`s NGS-based companion diagnostic (FoundationOne CDx) and approval of the 100 Ventana companion diagnostic 75 +124% • EU: Strong launch in key markets 50 +161% Outlook 2018 25 • Continued 1L momentum 0 • Updated mPFS data from Ph III study (ALEX) comparing Q1 15 Q1 16 Q1 17 Q1 18 Alecensa vs crizotinib to be presented at ASCO US Europe International Japan • Ph III adjuvant study (ALINA) initiated CER=Constant Exchange Rates; FMI=Foundation Medicine; NGS=next generation sequencing 20 Immunology: Annualized sales of around CHF 8bn CHFm YoY CER growth Immunology Q1 2018 +4% 2,000 +11% Esbriet (+13%) +16% 1,600 • Penetration in mild to moderate patient segment increasing +20% Xolair (+7%) 1,200 • Growth driven by pediatric asthma, allergic asthma and CIU 800 Actemra (+13%) • Launch in giant cell arteritis ongoing 400 • Auto-injector approved in the EU and Australia 0 Q1 15 Q1 16 Q1 17 Q1 18 Outlook 2018 MabThera/Rituxan (RA) Actemra IV Actemra SC Xolair • Strong growth expected with the exception of MabThera CellCept Pulmozyme Esbriet Other CER=Constant Exchange Rates; CIU=chronic idiopathic urticaria 21 Ocrevus: Strong EU launch; ~7% US market share after 3 quarters CHFm 600 Ocrevus Q1 2018 • Strong launches in EU and International 500 • US growing due to increasing number of returning patients 400 and new patients • RMS: 30% treatment naive/previously discontinued vs. 70% 300 switches from all other approved medications 200 Outlook 2018 100 • Continued launches in EU and International 0 • Further increasing US market share with earlier use Q2 17 Q3 17 Q4 17 Q1 18 US Europe International RMS=relapsing forms of multiple sclerosis 22 2018: New products with annualized sales of >CHF 8bn* ~80% of growth driven by new products * Venclexta sales are booked by partner AbbVie.
Load more

Recommended publications
  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
    [Show full text]
  • Roche/Genentech Managed RG7986 ADC R/R NHL CHU Chugai Managed IONIS IONIS Managed 74 Status As of January 28, 2016 PRO Proximagen Managed
    Roche 2015 results London, 28 January 2016 This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected.
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • Tanibirumab (CUI C3490677) Add to Cart
    5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor
    [Show full text]
  • 2017 Immuno-Oncology Medicines in Development
    2017 Immuno-Oncology Medicines in Development Adoptive Cell Therapies Drug Name Organization Indication Development Phase ACTR087 + rituximab Unum Therapeutics B-cell lymphoma Phase I (antibody-coupled T-cell receptor Cambridge, MA www.unumrx.com immunotherapy + rituximab) AFP TCR Adaptimmune liver Phase I (T-cell receptor cell therapy) Philadelphia, PA www.adaptimmune.com anti-BCMA CAR-T cell therapy Juno Therapeutics multiple myeloma Phase I Seattle, WA www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 "armored" CAR-T Juno Therapeutics recurrent/relapsed chronic Phase I cell therapy Seattle, WA lymphocytic leukemia (CLL) www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 CAR-T cell therapy Intrexon B-cell malignancies Phase I Germantown, MD www.dna.com ZIOPHARM Oncology www.ziopharm.com Boston, MA anti-CD19 CAR-T cell therapy Kite Pharma hematological malignancies Phase I (second generation) Santa Monica, CA www.kitepharma.com National Cancer Institute Bethesda, MD Medicines in Development: Immuno-Oncology 1 Adoptive Cell Therapies Drug Name Organization Indication Development Phase anti-CEA CAR-T therapy Sorrento Therapeutics liver metastases Phase I San Diego, CA www.sorrentotherapeutics.com TNK Therapeutics San Diego, CA anti-PSMA CAR-T cell therapy TNK Therapeutics cancer Phase I San Diego, CA www.sorrentotherapeutics.com Sorrento Therapeutics San Diego, CA ATA520 Atara Biotherapeutics multiple myeloma, Phase I (WT1-specific T lymphocyte South San Francisco, CA plasma cell leukemia www.atarabio.com
    [Show full text]
  • Current Strategies to Target Tumor-Associated-Macrophages to Improve Anti-Tumor Immune Responses
    cells Review Current Strategies to Target Tumor-Associated-Macrophages to Improve Anti-Tumor Immune Responses Clément Anfray 1, Aldo Ummarino 2 , Fernando Torres Andón 1,3 and Paola Allavena 1,* 1 IRCCS Istituto Clinico Humanitas, Via A. Manzoni 56, 20089 Rozzano, Milan, Italy; [email protected] (C.A.); [email protected] (F.T.A.) 2 Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy; [email protected] 3 Center for Research in Molecular Medicine & Chronic Diseases (CIMUS), Universidade, de Santiago de Compostela, Campus Vida, 15706 Santiago de Compostela, Spain * Correspondence: [email protected] Received: 4 December 2019; Accepted: 20 December 2019; Published: 23 December 2019 Abstract: Established evidence demonstrates that tumor-infiltrating myeloid cells promote rather than stop-cancer progression. Tumor-associated macrophages (TAMs) are abundantly present at tumor sites, and here they support cancer proliferation and distant spreading, as well as contribute to an immune-suppressive milieu. Their pro-tumor activities hamper the response of cancer patients to conventional therapies, such as chemotherapy or radiotherapy, and also to immunotherapies based on checkpoint inhibition. Active research frontlines of the last years have investigated novel therapeutic strategies aimed at depleting TAMs and/or at reprogramming their tumor-promoting effects, with the goal of re-establishing a favorable immunological anti-tumor response within the tumor tissue. In recent years, numerous clinical trials have included pharmacological strategies to target TAMs alone or in combination with other therapies. This review summarizes the past and current knowledge available on experimental tumor models and human clinical studies targeting TAMs for cancer treatment.
    [Show full text]
  • The Two Tontti Tudiul Lui Hi Ha Unit
    THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int .
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub
    US 20170172932A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub. Date: Jun. 22, 2017 (54) EARLY CANCER DETECTION AND A 6LX 39/395 (2006.01) ENHANCED IMMUNOTHERAPY A61R 4I/00 (2006.01) (52) U.S. Cl. (71) Applicant: Gholam A. Peyman, Sun City, AZ CPC .......... A61K 9/50 (2013.01); A61K 39/39558 (US) (2013.01); A61K 4I/0052 (2013.01); A61 K 48/00 (2013.01); A61K 35/17 (2013.01); A61 K (72) Inventor: sham A. Peyman, Sun City, AZ 35/15 (2013.01); A61K 2035/124 (2013.01) (21) Appl. No.: 15/143,981 (57) ABSTRACT (22) Filed: May 2, 2016 A method of therapy for a tumor or other pathology by administering a combination of thermotherapy and immu Related U.S. Application Data notherapy optionally combined with gene delivery. The combination therapy beneficially treats the tumor and pre (63) Continuation-in-part of application No. 14/976,321, vents tumor recurrence, either locally or at a different site, by filed on Dec. 21, 2015. boosting the patient’s immune response both at the time or original therapy and/or for later therapy. With respect to Publication Classification gene delivery, the inventive method may be used in cancer (51) Int. Cl. therapy, but is not limited to such use; it will be appreciated A 6LX 9/50 (2006.01) that the inventive method may be used for gene delivery in A6 IK 35/5 (2006.01) general. The controlled and precise application of thermal A6 IK 4.8/00 (2006.01) energy enhances gene transfer to any cell, whether the cell A 6LX 35/7 (2006.01) is a neoplastic cell, a pre-neoplastic cell, or a normal cell.
    [Show full text]
  • Ep 3178848 A1
    (19) TZZ¥__T (11) EP 3 178 848 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 14.06.2017 Bulletin 2017/24 C07K 16/28 (2006.01) A61K 39/395 (2006.01) C07K 16/30 (2006.01) (21) Application number: 15198715.3 (22) Date of filing: 09.12.2015 (84) Designated Contracting States: (72) Inventor: The designation of the inventor has not AL AT BE BG CH CY CZ DE DK EE ES FI FR GB yet been filed GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR (74) Representative: Cueni, Leah Noëmi et al Designated Extension States: F. Hoffmann-La Roche AG BA ME Patent Department Designated Validation States: Grenzacherstrasse 124 MA MD 4070 Basel (CH) (71) Applicant: F. Hoffmann-La Roche AG 4070 Basel (CH) (54) TYPE II ANTI-CD20 ANTIBODY FOR REDUCING FORMATION OF ANTI-DRUG ANTIBODIES (57) The present invention relates to methods of treating a disease, and methods for reduction of the formation of anti-drug antibodies (ADAs) in response to the administration of a therapeutic agent comprising administration of a Type II anti-CD20 antibody, e.g. obinutuzumab, to the subject prior to administration of the therapeutic agent. EP 3 178 848 A1 Printed by Jouve, 75001 PARIS (FR) EP 3 178 848 A1 Description Field of the Invention 5 [0001] The present invention relates to methods of treating a disease, and methods for reduction of the formation of anti-drug antibodies (ADAs) in response to the administration of a therapeutic agent.
    [Show full text]
  • The Current Landscape of Antibody-Based Therapies in Solid
    Theranostics 2021, Vol. 11, Issue 3 1493 Ivyspring International Publisher Theranostics 2021; 11(3): 1493-1512. doi: 10.7150/thno.52614 Review The Current Landscape of Antibody-based Therapies in Solid Malignancies Ashu Shah1, Sanchita Rauth1, Abhijit Aithal1, Sukhwinder Kaur1, Koelina Ganguly1, Catherine Orzechowski1, Grish C Varshney1, Maneesh Jain1,3 and Surinder K Batra1,2,3 1. Department of Biochemistry and Molecular Biology, University of Nebraska Medical Center, NE, 68198, USA. 2. Eppley Institute for Research in Cancer and Allied Diseases, University of Nebraska Medical Center, NE, 68198, USA. 3. Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, NE, 68198, USA. Corresponding authors: Surinder K. Batra, Ph.D., Maneesh Jain, Ph.D. Department of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, Nebraska, 68198-5870, USA. Phone: 402-559-5455, Fax: 402-559-6650, E-mail: [email protected]; [email protected]. © The author(s). This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/). See http://ivyspring.com/terms for full terms and conditions. Received: 2020.08.30; Accepted: 2020.10.21; Published: 2021.01.01 Abstract Over the past three decades, monoclonal antibodies (mAbs) have revolutionized the landscape of cancer therapy. Still, this benefit remains restricted to a small proportion of patients due to moderate response rates and resistance emergence. The field has started to embrace better mAb-based formats with advancements in molecular and protein engineering technologies. The development of a therapeutic mAb with long-lasting clinical impact demands a prodigious understanding of target antigen, effective mechanism of action, gene engineering technologies, complex interplay between tumor and host immune system, and biomarkers for prediction of clinical response.
    [Show full text]
  • KOL Event & Corporate Update
    KOL Event & Corporate Update April 6, 2017 NASDAQ: VBLT Agenda Opening remarks Dr. Ramy Ibrahim, MD – Parker institute for Cancer Immunotherapy New Targets and Immuno‐therapeutic Approaches in Oncology Prof. Dror Harats, MD – CEO, VBL Therapeutics VBL’s Novel Approach to Immune‐Oncology 2 Use of checkpoint modulators in Advanced malignancies Ramy Ibrahim, MD Head of Clinical Development Disclosures Paid consultant for Arcus therapeutics Honorarium from PER History and evolution of immunotherapy Immunotherapy Delivers In 2013, Science selected cancer immunotherapy as its Breakthrough of the Year. In 2014, the Wall Street Journal showcased cancer patients who were treated with immunotherapies and survived years beyond their initial prognosis. Ambitious goal with immunotherapy Traditional Therapies Immunotherapy 100% 100% Long Term Benefit Combinations of Traditional Immunotherapy Cancer Therapies Alive Alive Immunotherapy % of Treated %Patients of Treated % of Treated %Patients of Treated Traditional Therapies 0% 0% Time Time Patients ultimately succumb to their disease 2011: Immunotherapy delivered Long term benefit: Only 1in every 5 treated patients Mechanism of Action is simple… MEMORY cell Cancer cell It is more complicated…many pathways Some activate , others inhibit but many remain to be unknown Unleashing Immunotherapy’s Potential Multi disciplinary Genomics Immunomics Proteomics Microbiome Clinical Outcomes Data Science >1,250+ companies Biology >3,000 IO trials Oncology 100’s of research institutions Physics + Chemistry 100’s of
    [Show full text]
  • Roche Pharma Research & Early Development) Gred (Genentech Research & Early Development)
    Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Roche Group Q1 2018 results Diagnostics Foreign exchange rate information 48 Changes to the development pipeline Q1 2018 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 1 NME: 2 AIs: 1 AI: RG6148 NME –HER2+ BC RG6268 entrectinib – NSCLC ROS1+ RG7446 Tecentriq + Avastin – 1L HCC RG105 MabThera/Rituxan – pemphigus RG6173 NME – asthma RG7446 Tecentriq – SCCHN adj vulgaris 1 AI: 1 NME from Chugai: RG6268 entrectinib – NTRK1 pan tumor CHU NME - endometriosis 3 AIs: RG7421 Cotellic + Tecentriq – RCC, UC, H&N cancer RG7440 ipatasertib + Tecentriq + taxane - TNBC RG7601 Venclexta + Cotellic ± Tecentriq - MM Removed from phase I Removed from phase II Removed from phase III Removed from registration 1 NME: 1 NME: 1 NME following EU approval: RG7945 NME - glaucoma RG3637 lebrikizumab ± Esbriet – IPF RG6013 Hemlibra – hemophilia A FVIII inh 1 AI following US approval: RG3645 Lucentis 0.3mg PFS – DME/DR 49 Status as of April 26, 2018 Roche Group development pipeline Phase I (45 NMEs + 26 AIs) RG6264 Perjeta + Herceptin FDC SC HER2+ BC T + Cotellic solid tumors RG6069 anti-fibrotic agent fibrosis RG6026 CD20 TCB heme tumors T + ipi/IFN solid tumors RG6107 C5 inh MAb PNH RG6058 tiragolumab (TIGIT) ± T solid tumors T + Tarceva/Alecensa NSCLC RG6151 - asthma RG6109 - AML T + anti-CD20 combos heme tumors RG6173 - asthma RG6114 mPI3K alpha inh HR+ BC T ± lenalidomide ± daratumumab MM RG6174 - inflammatory diseases RG6146 BET inh combos solid + heme tumors RG7446 T + K/HP HER2+ BC RG7835 IgG-IL2 FP autoimmune diseases RG6148 - HER2+ BC T + HMA MDS RG7880 IL-22Fc inflammatory diseases RG6160 - multiple myeloma T + radium 223 mCRPC RG7990 - asthma RG6171 SERD (3) ER+ (HER2neg) mBC T + guadecitabine AML RG6004 HBV LNA HBV RG6180 personalized cancer vaccine ± T oncology T + rucaparib ovarian ca RG6080 nacubactam bact.
    [Show full text]