DOCSLIB.ORG

2018 Medicines in Development for Cancer

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
2018 Medicines in Development for Cancer 2018 Medicines in Development for Cancer Bladder Cancer Product Name Sponsor Indication Development Phase ABI-009 AADi Bioscience non-muscle invasive bladder cancer Phase I/II (nab-rapamycin/mTOR inhibitor) Los Angeles, CA www.aadibio.com ALT-801 Altor BioScience non-muscle invasive bladder cancer Phase I/II (tumor antigen-specific T-cell Miramar, FL www.altorbioscience.com receptor linked to IL-2) NantKwest Culver City, CA ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase II (IL-15 superagonist protein complex) Miramar, FL (BCG naïve) (Fast Track), www.altorbioscience.com NantKwest non-muscle invasive bladder cancer Culver City, CA (BCG unresponsive) (Fast Track) B-701 BioClin Therapeutics 2L locally advanced or metastatic Phase I/II (anti-FGFR3 mAb) San Ramon, CA bladder cancer www.bioclintherapeutics.com Bavencio® EMD Serono 1L urothelial cancer Phase III avelumab Rockland, MA www.emdserono.com (anti-PD-L1 inhibitor) Pfizer www.pfizer.com New York, NY BC-819 BioCanCell Therapeutics non-muscle invasive bladder cancer Phase II (gene therapy) Cambridge, MA (Fast Track) www.biocancell.com Medicines in Development: Cancer ǀ 2018 1 Bladder Cancer Product Name Sponsor Indication Development Phase Capzola® Spectrum Pharmaceuticals non-muscle invasive bladder cancer application submitted apaziquone Henderson, NV (Fast Track) www.sppirx.com Cavatak® Viralytics bladder cancer (+pembrolizumab) Phase I coxsackievirus Sydney, Australia www.viralytics.com CG0070 Cold Genesys non-muscle invasive bladder cancer Phase II (oncolytic immunotherapy) Santa Ana, CA www.coldgenesys.com Cotellic® Genentech urothelial cancer (+atezolizumab) Phase I cobimetinib South San Francisco, CA www.gene.com CV-301 Bavarian Nordic bladder cancer (+anti-PD-L1) Phase II (CEA-MUC-1-TRICOM cancer vaccine) Morrisville, NC www.bavarian-nordic.com Cyramza® Eli Lilly bladder cancer Phase III ramucirumab Indianapolis, IN www.lilly.com enfortumab vedotin (ASG-2ME) Astellas urothelial cancer Phase II (antibody-drug conjugate) Northbrook, IL www.astellas.com Seattle Genetics www.seattlegenetics.com Bothell, WA Halaven® Eisai bladder cancer Phase I/II eribulin Woodcliff Lake, NJ www.eisai.com Medicines in Development: Cancer ǀ 2018 2 Bladder Cancer Product Name Sponsor Indication Development Phase Imfinzi® MedImmune 1L bladder cancer (+tremelimumab) Phase III durvalumab Gaithersburg, MD www.medimmune.com 1L unresectable stage IV bladder Phase II cancer (+olaparib) www.medimmune.com INCB54828 Incyte bladder cancer Phase II (FGFR1/2/3 inhibitor) Wilmington, DE www.incyte.com INO-5401 Inovio Pharmaceuticals bladder cancer Phase II (T-cell activating DNA immunotherapy) Plymouth Meeting, PA www.inovio.com MAGE-A10 TCR Adaptimmune bladder cancer Phase I/II (T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com MV-NIS Vyriad bladder cancer Phase I (oncolytic virus cancer vaccine) Rochester, MN www.vyriad.com nadofaragene firadenovec FKD Therapies superficial bladder cancer Phase III (IFNA2B gene therapy) Kuopio, Finland NC-6004 NanoCarrier bladder cancer (+gemcitabine) Phase II (cisplatin micellar nanoparticle) Chiba, Japan www.nanocarrier.co.jp NEO-PV-01 Neon Therapeutics bladder cancer Phase I (personal neo-antigen vaccine) Cambridge, MA www.neontherapeutics.com Medicines in Development: Cancer ǀ 2018 3 Bladder Cancer Product Name Sponsor Indication Development Phase Opdivo® + Yervoy® Bristol-Myers Squibb urothelial cancer Phase III nivolumab + ipilimumab Princeton, NJ www.bms.com Rubraca® Clovis Oncology advanced or metastatic bladder cancer Phase II rucaparib Boulder, CO www.clovisoncology.com (PARP inhibitor) RX-3117 Rexahn Pharmaceuticals metastatic bladder cancer Phase II (DNA and RNA synthesis inhibitor) Rockville, MD www.rexahn.com sacituzumab govitecan Immunomedics metastatic urothelial cancer Phase II (anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com TAR-200 TARIS Biomedical non-muscle invasive bladder cancer, Phase I (DNA synthesis inhibitor) Lexington, MA muscle invasive bladder cancer www.tarisbiomedical.com (Fast Track) Tecentriq® Genentech muscle-invasive bladder cancer, Phase III atezolizumab South San Francisco, CA 1L metastatic urothelial cancer www.gene.com (+/- chemotherapy) non-muscle invasive bladder cancer Phase I www.gene.com VesiGel™ UroGen Pharma bladder cancer (Fast Track) Phase II mitomycin intravesicular New York, NY www.urogen.com ORPHAN DRUG Medicines in Development: Cancer ǀ 2018 4 Bladder Cancer Product Name Sponsor Indication Development Phase Vesimune™ UroGen Pharma high-grade non-muscle invasive Phase II imiquimod intravesicular New York, NY bladder cancer www.urogen.com ORPHAN DRUG Vicinium™ Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder cancer www.elevenbio.com BCG-refractory high-grade non-muscle Phase I invasive bladder cancer (+durvalumab) www.elevenbio.com Brain Cancer Product Name Sponsor Indication Development Phase 2X-111 2X Oncology brain metastases from breast cancer, Phase I completed (liposomal doxorubicin) Cambridge, MA recurrent glioblastoma www.2xoncology.com ORPHAN DRUG abexinostat Xynomic Pharmaceuticals brain Phase I (HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com Ad-RTS-hIL12 ZIOPHARM Oncology glioblastoma Phase II (DNA-based therapy) Boston, MA www.ziopharm.com ORPHAN DRUG glioblastoma (+nivolumab), Phase I glioblastoma (stereotactic treatment), www.ziopharm.com pediatric brain tumors Medicines in Development: Cancer ǀ 2018 5 Brain Cancer Product Name Sponsor Indication Development Phase AG-881 Agios Pharmaceuticals glioma Phase I (pan-IDH inhibitor) Cambridge, MA www.celgene.com Celgene Summit, NJ aglatimagene besadenovec Advantagene glioma, pediatric glioma Phase II (gene therapy) Auburndale, MA www.advantagene.com ORPHAN DRUG pediatric brain tumors Phase I www.advantagene.com AMG 596 Amgen glioblastoma Phase I (anti-EGFRvIII x anti-CD3 Thousand Oaks, CA www.amgen.com bispecific T-cell engager) ANG1005 AngioChem brain metastases from breast cancer, Phase II (peptide-paclitaxel conjugate) Montreal, Canada glioblastoma (Fast Track) www.angiochem.com ORPHAN DRUG antineoplaston therapy Burzynski Research Institute diffuse intrinsic pontine glioma Phase II ORPHAN DRUG Houston, TX www.burzynskiresearch.com APX005M Apexigen recurrent refractory brain tumors Phase I (CD40 agonistic antibody) San Carlos, CA www.apexigen.com AU101 Aurora BioPharma recurrent glioblastoma Phase I/II (HER2-CD28 CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com Medicines in Development: Cancer ǀ 2018 6 Brain Cancer Product Name Sponsor Indication Development Phase AU105 Aurora BioPharma newly-diagnosed glioblastoma Phase I/II (HER2-CMV CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com Avastin® Genentech brain metastases Phase II bevacizumab South San Francisco, CA www.gene.com AZD1390 AstraZeneca glioblastoma (+radiation) Phase I (ATM kinase inhibitor) Wilmington, DE www.astrazeneca.com Azixa® Cytovia glioblastoma Phase II verubulin Englewood Cliffs, NJ www.immunepharma.com ORPHAN DRUG BAL101553 Basilea Pharmaceutica newly-diagnosed glioblastoma Phase I (tumor checkpoint inhibitor) Basel, Switzerland www.basilea.com Adult Brain Tumor Consortium Baltimore, MD bavituximab Oncologie newly-diagnosed glioblastoma Phase II Boston, MA www.oncologie.international BMX-001 BioMimetix glioma Phase I/II (mangano porphyrin antioxidant Greenwood Village, CO www.biomimetix.com mimetic) BXQ-350 Bexion Pharmaceuticals glioblastoma Phase I (apoptosis stimulant) Covington, KY www.bexionpharma.com ORPHAN DRUG Medicines in Development: Cancer ǀ 2018 7 Brain Cancer Product Name Sponsor Indication Development Phase capmatinib (INC280) Novartis Oncology glioblastoma (combination therapy) Phase I completed (c-Met inhibitor) East Hanover, NJ www.novartis.com Incyte Wilmington, DE CC-122 (avadomide) Celgene glioblastoma Phase I (pleiotropic pathway modulator) Summit, NJ www.celgene.com Cerebral EDV™ EnGeneIC glioblastoma Phase I doxorubicin encapsulated nanocells New York, NY www.engeneic.com ORPHAN DRUG DCC-2618 Deciphera Pharmaceuticals glioblastoma, glioma Phase I (PDGFR-alpha kinase switch Waltham, MA www.deciphera.com control inhibitor) ORPHAN DRUG DCVax®-L Northwest Biotherapeutics glioblastoma Phase III cancer vaccine Bethesda, MD www.nwbio.com ORPHAN DRUG depatuxizumab mafodotin AbbVie glioblastoma Phase III (anti-EGFR antibody-drug conjugate) North Chicago, IL www.abbvie.com ORPHAN DRUG pediatric brain tumors Phase I www.abbvie.com Medicines in Development: Cancer ǀ 2018 8 Brain Cancer Product Name Sponsor Indication Development Phase Dicopp™ Cantex Pharmaceuticals recurrent glioblastoma Phase II copper gluconate/disulfiram Weston, FL www.cantex.com ORPHAN DRUG DM-CHOC-PEN Dekk-Tec primary brain cancer, Phase II New Orleans, LA brain metastases www.dekk-tec.com DSP-7888 Sumitomo Dainippon Pharma recurrent glioblastoma Phase II (adegramotide/nelatimotide) Osaka, Japan (combination therapy) www.ds-pharma.com ORPHAN DRUG eflornithine oral Orbus Therapeutics anaplastic astrocytoma Phase III (ornithine decarboxylase inhibitor) Palo Alto, CA www.orbustherapeutics.com ORPHAN DRUG epacadostat Incyte glioblastoma Phase I (IDO1 inhibitor) Wilmington, DE www.incyte.com ERC1671 Epitopoietic Research glioblastoma Phase II (therapeutic cancer vaccine) Pasadena, CA www.erc-immunotherapy.com ORPHAN DRUG fimepinostat (CUDC-907) Curis brain tumor Phase I (HDAC/PI3K inhibitor) Lexington, MA www.curis.com Medicines in Development: Cancer ǀ 2018
Load more

Recommended publications
  • Genmab and ADC Therapeutics Announce Amended Agreement for Camidanlumab Tesirine (Cami)
    Genmab and ADC Therapeutics Announce Amended Agreement for Camidanlumab Tesirine (Cami) Media Release Copenhagen, Denmark and Lausanne, Switzerland, October 30, 2020 • ADC Therapeutics to continue the development and commercialization of Cami • Genmab to receive mid-to-high single-digit tiered royalty Genmab A/S (Nasdaq: GMAB) and ADC Therapeutics SA (NYSE: ADCT) today announced that they have executed an amended agreement for ADC Therapeutics to continue the development and commercialization of camidanlumab tesirine (Cami). The parties first entered into a collaboration and license agreement in June 2013 for the development of Cami, an antibody drug conjugate (ADC) which combines Genmab’s HuMax®-TAC antibody targeting CD25 with ADC Therapeutics’ highly potent pyrrolobenzodiazepine (PBD) warhead technology. Under the terms of the 2013 agreement, the parties were to determine the path forward for continued development and commercialization of Cami upon completion of a Phase 1a/b clinical trial. ADC Therapeutics previously announced that Cami achieved an overall response rate of 86.5%, including a complete response rate of 48.6%, in Hodgkin lymphoma patients in this trial who had received a median of five prior lines of therapy. Cami is currently being evaluated in a 100-patient pivotal Phase 2 clinical trial intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The trial is more than 50 percent enrolled and ADC Therapeutics anticipates reporting interim results in the first half of 2021. “We have a long-standing relationship with the ADC Therapeutics team and believe they are an ideal partner for the ongoing development and potential commercialization of Cami,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
    [Show full text]
  • Single Dose of the CXCR4 Antagonist BL-8040 Induces Rapid
    Published OnlineFirst August 23, 2017; DOI: 10.1158/1078-0432.CCR-16-2919 Cancer Therapy: Clinical Clinical Cancer Research Single Dose of the CXCR4 Antagonist BL-8040 Induces Rapid Mobilization for the Collection of Human CD34þ Cells in Healthy Volunteers Michal Abraham1, Yaron Pereg2, Baruch Bulvik1, Shiri Klein3, Inbal Mishalian3, Hana Wald1, Orly Eizenberg1, Katia Beider4, Arnon Nagler4, Rottem Golan2, Abi Vainstein2, Arnon Aharon2, Eithan Galun3, Yoseph Caraco5, Reuven Or6, and Amnon Peled3,4 Abstract Purpose: The potential of the high-affinity CXCR4 antagonist systemic reactions were mitigated by methylprednisolone, BL-8040 as a monotherapy-mobilizing agent and its derived paracetamol, and promethazine pretreatment. In the first part graft composition and quality were evaluated in a phase I clinical of the study, BL-8040 triggered rapid and substantial mobili- þ study in healthy volunteers (NCT02073019). zation of WBCs and CD34 cells in all tested doses. Four hours Experimental Design: The first part of the study was a ran- postdose, the count rose to a mean of 8, 37, 31, and 35 cells/mL domized, double-blind, placebo-controlled dose escalation (placebo, 0.5, 0.75, and 1 mg/kg, respectively). FACS analysis phase. The second part of the study was an open-label phase, in revealed substantial mobilization of immature dendritic, T, B, þ which 8 subjects received a single injection of BL-8040 (1 mg/kg) and NK cells. In the second part, the mean CD34 cells/kg and approximately 4 hours later underwent a standard leukapher- collected were 11.6 Â 106 cells/kg. The graft composition was esis procedure.
    [Show full text]
  • ADC Therapeutics SA (Exact Name of Registrant As Specified in Its Charter)
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of July, 2020. Commission File Number: 001-39071 ADC Therapeutics SA (Exact name of registrant as specified in its charter) Biopôle Route de la Corniche 3B 1066 Epalinges Switzerland (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: Form 20-F ☒ Form 40-F Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐ SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. ADC Therapeutics SA Date: July 6, 2020 By: /s/ Dominique Graz Name: Dominique Graz Title: General Counsel EXHIBIT INDEX Exhibit No. Description 99.1 Press release dated July 6, 2020 Exhibit 99.1 ADC Therapeutics Announces U.S. Food and Drug Administration Has Lifted Partial Clinical Hold on Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine Lausanne, Switzerland — July 6, 2020 — ADC Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, today announced that the U.S.
    [Show full text]
  • 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]
  • Antibody Drug Conjugate Development in Gastrointestinal Cancers: Hopes and Hurdles from Clinical Trials
    Wu et al. Cancer Drug Resist 2018;1:204-18 Cancer DOI: 10.20517/cdr.2018.16 Drug Resistance Review Open Access Antibody drug conjugate development in gastrointestinal cancers: hopes and hurdles from clinical trials Xiaorong Wu, Thomas Kilpatrick, Ian Chau Department of Medical oncology, Royal Marsden Hospital NHS foundation trust, Sutton SM2 5PT, UK. Correspondence to: Dr. Ian Chau, Department of Medical Oncology, Royal Marsden Hospital NHS foundation trust, Downs Road, Sutton SM2 5PT, UK. E-mail: [email protected] How to cite this article: Wu X, Kilpatrick T, Chau I. Antibody drug conjugate development in gastrointestinal cancers: hopes and hurdles from clinical trials. Cancer Drug Resist 2018;1:204-18. http://dx.doi.org/10.20517/cdr.2018.16 Received: 31 Aug 2018 First Decision: 8 Oct 2018 Revised: 13 Nov 2018 Accepted: 16 Nov 2018 Published: 19 Dec 2018 Science Editors: Elisa Giovannetti, Jose A. Rodriguez Copy Editor: Cui Yu Production Editor: Huan-Liang Wu Abstract Gastrointestinal (GI) cancers represent the leading cause of cancer-related mortality worldwide. Antibody drug conjugates (ADCs) are a rapidly growing new class of anti-cancer agents which may improve GI cancer patient survival. ADCs combine tumour-antigen specific antibodies with cytotoxic drugs to deliver tumour cell specific chemotherapy. Currently, only two ADCs [brentuximab vedotin and trastuzumab emtansine (T-DM1)] have been Food and Drug Administration approved for the treatment of lymphoma and metastatic breast cancer, respectively. Clinical research evaluating ADCs in GI cancers has shown limited success. In this review, we will retrace the relevant clinical trials investigating ADCs in GI cancers, especially ADCs targeting human epidermal growth receptor 2, mesothelin, guanylyl cyclase C, carcinogenic antigen-related cell adhesion molecule 5 (also known as CEACAM5) and other GI malignancy specific targets.
    [Show full text]
  • Say on Pay Results (As of September 5)
    THIS REPORT CAN BE ACCESSED AT HTTP://WWW.SEMLERBROSSY.COM/SAYONPAY NOTE: THIS WILL BE OUR FINAL SAY ON PAY UPDATE FOR 2012. WE WILL ISSUE A FULL REPORT PROVIDING RESULTS FOR THE ENTIRE 2012 PROXY SEASON IN JANUARY 2013. PLEASE CONTINUE TO VISIT OUR SAY ON PAY BLOG FOR UPDATES. SAY ON PAY RESULTS 2012 RUSSELL 3000 SEPTEMBER 5 2012 SAY ON PAY RESULTS: RUSSELL 3000 SHAREHOLDER VOTING SUMMARY OF FINDINGS 2012 Vote Results (n=2,025) 2 The majority of companies continue to pass Say on Pay in 2012 with substantial shareholder support: — 1,466 companies (72%) passed with over 90% support — 381 companies (19%) passed with between 70% and 90% support — 125 companies (6%) passed with between 50% and 70% support — 53 companies (2.6%) in the Russell 3000 have failed Vote of the Week McKesson received a vote of 62%, a decline of 8% from 2011, amidst criticism from shareholders and 3 their advisors over high relative CEO pay and retirement benefits Vote Results by Industry Health Care companies have received proportionally less support than other industries, while 4 Consumer Staple and Financial companies have received the most support Vote Results and Market Value 5 There does not appear to be a strong correlation between a company’s market value and Say on Pay vote result How Vote Results Changed in 2012 6 Companies below 70% in 2011 have generally received increased vote support in 2012: — 26 of 30 companies that failed in 2011 have passed in 2012 — Companies between 50‐70% in 2011 have improved by an average of 13% in 2012 Vote results for companies
    [Show full text]
  • Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix
    United States International Trade Commission Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix USITC Publication 4208 December 2010 U.S. International Trade Commission COMMISSIONERS Deanna Tanner Okun, Chairman Irving A. Williamson, Vice Chairman Charlotte R. Lane Daniel R. Pearson Shara L. Aranoff Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix Publication 4208 December 2010 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 15, 2010, set forth at the end of this publication, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the United States International Trade Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement changes to the Pharmaceutical Appendix, effective on January 1, 2011. Table 1 International Nonproprietary Name (INN) products proposed for addition to the Pharmaceutical Appendix to the Harmonized Tariff Schedule INN CAS Number Abagovomab 792921-10-9 Aclidinium Bromide 320345-99-1 Aderbasib 791828-58-5 Adipiplon 840486-93-3 Adoprazine 222551-17-9 Afimoxifene 68392-35-8 Aflibercept 862111-32-8 Agatolimod
    [Show full text]
  • Modulators of CXCR4 and CXCR7/ACKR3 Function
    Molecular Pharmacology Fast Forward. Published on September 23, 2019 as DOI: 10.1124/mol.119.117663 This article has not been copyedited and formatted. The final version may differ from this version. MOL # 117663 Modulators of CXCR4 and CXCR7/ACKR3 function Ilze Adlere*, Birgit Caspar*, Marta Arimont*, Sebastian Dekkers, Kirsten Visser, Jeffrey Stuijt, Chris de Graaf, Michael Stocks, Barrie Kellam, Stephen Briddon, Maikel Wijtmans, Iwan de Esch, Stephen Hill, Rob Leurs# * These authors contributed equally to this work. Downloaded from # Corresponding author molpharm.aspetjournals.org Griffin Discoveries BV, Amsterdam, The Netherlands (IA, IE, RL), Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, University of Nottingham, Nottingham, UK (BC, SJB, SJH), Centre of Membrane Proteins and Receptors (COMPARE), Universities of Birmingham and Nottingham, The Midlands, U.K. (BC, BK, SD, SB, SH), at ASPET Journals on September 26, 2021 School of Pharmacy, University of Nottingham, Nottingham, U.K. (SD, BK, MS), Division of Medicinal Chemistry, Amsterdam Institute for Molecules, Medicines and Systems, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands (MA, KS, JS, CG, MW, IE, RL), Sosei Heptares, Cambridge, U.K. (CG) 1 Molecular Pharmacology Fast Forward. Published on September 23, 2019 as DOI: 10.1124/mol.119.117663 This article has not been copyedited and formatted. The final version may differ from this version. MOL # 117663 Running title: Modulators of CXCR4 and CXCR7/ACKR3 function Corresponding
    [Show full text]
  • The Pipeline Report 2016 Pipeline 2014 Autoimmune
    THE PIPELINE REPORT 2016 PIPELINE 2014 AUTOIMMUNE PRODUCTS GENERATING BUZZ OTHER KEY PRODUCTS IN THE PIPELINE BIG-TIME Baricitinib Eli Lilly/Incyte Indication: RA (Ph.III) Romosozumab Amgen/UCB Sirukumab Janssen Biotech RA What the clinical trials found: The daily oral demonstrated superiority Osteoporosis (Ph.III) (Ph.III) compared to placebo after 12 weeks based on ACR20 response (Ph. Avatrombopag Astellas Pharma Anifrolumab Medarex/Med­ III RA-BEAM). The agent also proved superior to adalimumab on ITP/thrombocytopenia (Ph.III) Immune Systemic lupus erythema- tosus (Ph.III) key secondary objectives of ACR20 response and improvement in Elobixibat AstraZeneca CIC and DAS28-hsCRP score. A few occasional AEs were reported. IBS-C (Ph.III) Odanacatib Merck Osteoporosis (Ph.III) Credit Suisse Success Probability and inThought Comment: 70%. Lesinurad AstraZeneca Gout (Ph. III) Tildrakizumab Merck Psoriasis The JAK inhibitor appears to have similar efficacy and safety to (Ph.III) Pfizer’s Xeljanz. It was supposed to have a once daily vs. Xeljanz’s Alicaforsen Atlantic Healthcare Pouchitis/ulcerative colitis (Ph.III) Siponimod Novartis MS (Ph.III) twice daily advantage, but Xeljanz’s once daily formulation will likely be approved soon. It’ll be interesting to see if Lilly/Incyte Rituximab biosimilar Boehringer Infliximab biosimilar Pfizer RA Ingelheim RA (Ph.III) (Ph.III) can do something with patient access and price to improve upon Mongersen Celgene/Nogra RHB 104 RedHill Biopharma the poor performance of Xeljanz and expand the JAK inhibitor Pharma Crohn’s disease (Ph.III) Crohn’s disease (Ph.III) market. Expected launch: 2016 (Source: Credit Suisse) Etanercept biosimilar Coherus Sarilumad Regeneron RA (Ph.III) Credit Suisse forecast: $1.09 billion in global annual sales by 2020 Biosciences/Daiichi Sankyo/ Etrolizumab Roche Ulcerative A peek at 159 aspiring agents, with profiles on 17 that could shoot to stardom.
    [Show full text]
  • Cancer Drug Pharmacology Table
    CANCER DRUG PHARMACOLOGY TABLE Cytotoxic Chemotherapy Drugs are classified according to the BC Cancer Drug Manual Monographs, unless otherwise specified (see asterisks). Subclassifications are in brackets where applicable. Alkylating Agents have reactive groups (usually alkyl) that attach to Antimetabolites are structural analogues of naturally occurring molecules DNA or RNA, leading to interruption in synthesis of DNA, RNA, or required for DNA and RNA synthesis. When substituted for the natural body proteins. substances, they disrupt DNA and RNA synthesis. bendamustine (nitrogen mustard) azacitidine (pyrimidine analogue) busulfan (alkyl sulfonate) capecitabine (pyrimidine analogue) carboplatin (platinum) cladribine (adenosine analogue) carmustine (nitrosurea) cytarabine (pyrimidine analogue) chlorambucil (nitrogen mustard) fludarabine (purine analogue) cisplatin (platinum) fluorouracil (pyrimidine analogue) cyclophosphamide (nitrogen mustard) gemcitabine (pyrimidine analogue) dacarbazine (triazine) mercaptopurine (purine analogue) estramustine (nitrogen mustard with 17-beta-estradiol) methotrexate (folate analogue) hydroxyurea pralatrexate (folate analogue) ifosfamide (nitrogen mustard) pemetrexed (folate analogue) lomustine (nitrosurea) pentostatin (purine analogue) mechlorethamine (nitrogen mustard) raltitrexed (folate analogue) melphalan (nitrogen mustard) thioguanine (purine analogue) oxaliplatin (platinum) trifluridine-tipiracil (pyrimidine analogue/thymidine phosphorylase procarbazine (triazine) inhibitor)
    [Show full text]
  • Preclinical Efficacy of an Antibody–Drug Conjugate Targeting
    Published OnlineFirst October 19, 2016; DOI: 10.1158/1535-7163.MCT-16-0449 Large Molecule Therapeutics Molecular Cancer Therapeutics Preclinical Efficacy of an Antibody–Drug Conjugate Targeting Mesothelin Correlates with Quantitative 89Zr-ImmunoPET Anton G.T. Terwisscha van Scheltinga1,2, Annie Ogasawara1, Glenn Pacheco1, Alexander N. Vanderbilt1, Jeff N. Tinianow1, Nidhi Gupta1, Dongwei Li1, Ron Firestein1, Jan Marik1, Suzie J. Scales1, and Simon-Peter Williams1 Abstract Antibody–drug conjugates (ADC) use monoclonal antibo- and HPAF-II, or mesothelioma MSTO-211H. Ex vivo analysis dies (mAb) as vehicles to deliver potent cytotoxic drugs selec- of mesothelin expression was performed using immunohis- tively to tumor cells expressing the target. Molecular imaging tochemistry. AMA-MMAE showed the greatest growth inhibi- with zirconium-89 (89Zr)-labeled mAbs recapitulates similar tion in OVCAR-3Â2.1, Capan-2, and HPAC tumors, which targeting biology and might help predict the efficacy of these showed target-specific tumor uptake of 89Zr-AMA. The less ADCs. An anti-mesothelin antibody (AMA, MMOT0530A) was responsive xenografts (AsPC-1, HPAF-II, and MSTO-211H) did used to make comparisons between its efficacy as an ADC and not show 89Zr-AMA uptake despite confirmed mesothelin its tumor uptake as measured by 89Zr immunoPET imaging. expression. ImmunoPET can demonstrate the necessary deliv- Mesothelin-targeted tumor growth inhibition by monomethyl ery, binding, and internalization of an ADC antibody in vivo auristatin E (MMAE), ADC AMA-MMAE (DMOT4039A), andthiscorrelateswiththeefficacy of mesothelin-targeted ADC was measured in mice bearing xenografts of ovarian cancer in tumors vulnerable to the cytotoxic drug delivered. Mol Cancer OVCAR-3Â2.1, pancreatic cancers Capan-2, HPAC, AsPC-1, Ther; 16(1); 134–42.
    [Show full text]
  • 2015 Post-ASH Report
    Datamonitor Healthcare Trialtrove Biomedtracker Pharma intelligence | Pharma intelligence | Pharma intelligence | 2015 Post-ASH Report RACHEL MEIGHAN-MANTHA Principal Analyst, Citeline JOSEPH HEDDEN Senior Analyst, Datamonitor Healthcare Summary Profiled themes at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH), held December 5-8, 2015, in Orlando, Florida, included Genomic Profiling and Chemical Biology, Genome Editing and Gene Therapy, Epigenetic Mechanisms, Immunologic Treatments, Stem Cell Biology and Regenerative Medicine and Preventing Venous Thromboembolic Disease. This report will mainly focus on the theme of Immunologic Treatments because of the importance and popularity of immunotherapies for many different hematological cancers. Also covered in this report are the results from pivotal trials presented at ASH, as well as highlights from other drugs/therapies of interest. In addition, we felt it was important to cover first-in-human trials since (hopefully) some of these drugs/therapies will be in pivotal trials in a few years. At the end of the report, we’ve included a section showcasing drugs that had top- line results presented at ASH, followed by a list of other data presentations supplied by BioMedTracker (BMT). Accompanying links to BioMedTracker events along with changes to the drugs’ likelihood of approval (LOA) are also provided throughout the report. Finally, additional supplemental material related to ASH is listed in the Appendix. 2 Datamonitor Healthcare Trialtrove Biomedtracker
    [Show full text]