2020 Medicines in Development ꟷ Cancer
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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. -
Screening and Identification of Key Biomarkers in Clear Cell Renal Cell Carcinoma Based on Bioinformatics Analysis
bioRxiv preprint doi: https://doi.org/10.1101/2020.12.21.423889; this version posted December 23, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Screening and identification of key biomarkers in clear cell renal cell carcinoma based on bioinformatics analysis Basavaraj Vastrad1, Chanabasayya Vastrad*2 , Iranna Kotturshetti 1. Department of Biochemistry, Basaveshwar College of Pharmacy, Gadag, Karnataka 582103, India. 2. Biostatistics and Bioinformatics, Chanabasava Nilaya, Bharthinagar, Dharwad 580001, Karanataka, India. 3. Department of Ayurveda, Rajiv Gandhi Education Society`s Ayurvedic Medical College, Ron, Karnataka 562209, India. * Chanabasayya Vastrad [email protected] Ph: +919480073398 Chanabasava Nilaya, Bharthinagar, Dharwad 580001 , Karanataka, India bioRxiv preprint doi: https://doi.org/10.1101/2020.12.21.423889; this version posted December 23, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Abstract Clear cell renal cell carcinoma (ccRCC) is one of the most common types of malignancy of the urinary system. The pathogenesis and effective diagnosis of ccRCC have become popular topics for research in the previous decade. In the current study, an integrated bioinformatics analysis was performed to identify core genes associated in ccRCC. An expression dataset (GSE105261) was downloaded from the Gene Expression Omnibus database, and included 26 ccRCC and 9 normal kideny samples. Assessment of the microarray dataset led to the recognition of differentially expressed genes (DEGs), which was subsequently used for pathway and gene ontology (GO) enrichment analysis. -
A Forum Report on Continuous Manufacturing for Biologics
A Forum Report on Continuous Manufacturing for Biologics CMC Strategy Forum Jan 28, 2019 in Washington , DC Andrew Chang, Ph.D. Vice President, Quality and Regulatory Compliance, Novo Nordisk Quality Novo Nordisk A/S Agenda 1 Overview the Forum Program 2 Key Learnings: Small Molecules vs. Biologics 3 Panel Discussion Outcome Opportunities and Challenges Central Questions Raised for planning the Positive Regulatory Environment CMC Strategy Forum on Continuous Manufacturing for Biologics • What are the business opportunities for introducing continuous manufacturing for biologics? • What are current gaps and hurdles for implementing continuous manufacturing for biologics? • What levels of automation in biopharmaceuticals is needed for continuous manufacturing? • What novel analytical technologies are Dr. Rapti D. Madurawe, needed for continuous manufacturing? FDA/CDER/OPQ/OPF, 2019 DIA CMC Workshop • What can we leverage from our knowledge of small molecule continuous manufacturing to enable or accelerate continuous manufacturing for biologics? The Forum Overview (1) Morning Session (Co-Chairs: Lindsay Arnold, MedImmune and Min Zhu, Boehringer Ingelheim Biopharmaceuticals ) • Industry Perspectives • Small molecule experience - Thomas Garcia, Pfizer, Inc. • Continuous biomanufacturing: experience and emerging opportunities - Erik Fouts, BioMarin Pharmaceutical Inc. • Analytical Technologies • Control of continuous bioprocess (PAT) - Mark Brower, Merck & Co., Inc., • Panel Discussion • Participants will discuss pre-identified issues and brainstorm -
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. -
Propranolol-Mediated Attenuation of MMP-9 Excretion in Infants with Hemangiomas
Supplementary Online Content Thaivalappil S, Bauman N, Saieg A, Movius E, Brown KJ, Preciado D. Propranolol-mediated attenuation of MMP-9 excretion in infants with hemangiomas. JAMA Otolaryngol Head Neck Surg. doi:10.1001/jamaoto.2013.4773 eTable. List of All of the Proteins Identified by Proteomics This supplementary material has been provided by the authors to give readers additional information about their work. © 2013 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 eTable. List of All of the Proteins Identified by Proteomics Protein Name Prop 12 mo/4 Pred 12 mo/4 Δ Prop to Pred mo mo Myeloperoxidase OS=Homo sapiens GN=MPO 26.00 143.00 ‐117.00 Lactotransferrin OS=Homo sapiens GN=LTF 114.00 205.50 ‐91.50 Matrix metalloproteinase‐9 OS=Homo sapiens GN=MMP9 5.00 36.00 ‐31.00 Neutrophil elastase OS=Homo sapiens GN=ELANE 24.00 48.00 ‐24.00 Bleomycin hydrolase OS=Homo sapiens GN=BLMH 3.00 25.00 ‐22.00 CAP7_HUMAN Azurocidin OS=Homo sapiens GN=AZU1 PE=1 SV=3 4.00 26.00 ‐22.00 S10A8_HUMAN Protein S100‐A8 OS=Homo sapiens GN=S100A8 PE=1 14.67 30.50 ‐15.83 SV=1 IL1F9_HUMAN Interleukin‐1 family member 9 OS=Homo sapiens 1.00 15.00 ‐14.00 GN=IL1F9 PE=1 SV=1 MUC5B_HUMAN Mucin‐5B OS=Homo sapiens GN=MUC5B PE=1 SV=3 2.00 14.00 ‐12.00 MUC4_HUMAN Mucin‐4 OS=Homo sapiens GN=MUC4 PE=1 SV=3 1.00 12.00 ‐11.00 HRG_HUMAN Histidine‐rich glycoprotein OS=Homo sapiens GN=HRG 1.00 12.00 ‐11.00 PE=1 SV=1 TKT_HUMAN Transketolase OS=Homo sapiens GN=TKT PE=1 SV=3 17.00 28.00 ‐11.00 CATG_HUMAN Cathepsin G OS=Homo -
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. -
A Phase Ib/II Study of Xentuzumab, an IGF-Neutralising Antibody
Schmid et al. Breast Cancer Research (2021) 23:8 https://doi.org/10.1186/s13058-020-01382-8 RESEARCH ARTICLE Open Access A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer Peter Schmid1*, Marie-Paule Sablin2, Jonas Bergh3, Seock-Ah Im4, Yen-Shen Lu5, Noelia Martínez6, Patrick Neven7, Keun Seok Lee8, Serafín Morales9, J. Alejandro Pérez-Fidalgo10, Douglas Adamson11, Anthony Gonçalves12, Aleix Prat13, Guy Jerusalem14, Laura Schlieker15, Rosa-Maria Espadero16, Thomas Bogenrieder17,18, Dennis Chin-Lun Huang19,20, John Crown21† and Javier Cortés22,23† Abstract Background: Xentuzumab—a humanised IgG1 monoclonal antibody—binds IGF-1 and IGF-2, inhibiting their growth-promoting signalling and suppressing AKT activation by everolimus. This phase Ib/II exploratory trial evaluated xentuzumab plus everolimus and exemestane in hormone receptor-positive, locally advanced and/or metastatic breast cancer (LA/MBC). Methods: Patients with hormone receptor-positive/HER2-negative LA/MBC resistant to non-steroidal aromatase inhibitors were enrolled. Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of xentuzumab/ everolimus/exemestane were determined in phase I (single-arm, dose-escalation). In phase II (open-label), patients were randomised 1:1 to the RP2D of xentuzumab/everolimus/exemestane or everolimus/exemestane alone. Randomisation was stratified by the presence of visceral metastases. Primary endpoint was progression-free survival (PFS). (Continued on next page) * Correspondence: [email protected] †John Crown and Javier Cortés contributed equally to this work. 1Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK Full list of author information is available at the end of the article © The Author(s). -
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 -
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. -
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. -
New Contributions in Undergraduate Research
PSU McNair Scholars Online Journal Volume 11 Issue 1 Without Borders: Original Contributions Article 6 in Undergraduate Research 2017 Wings Outstretched: New Contributions in Undergraduate Research Follow this and additional works at: https://pdxscholar.library.pdx.edu/mcnair Let us know how access to this document benefits ou.y Recommended Citation (2017) "Wings Outstretched: New Contributions in Undergraduate Research," PSU McNair Scholars Online Journal: Vol. 11: Iss. 1, Article 6. https://doi.org/10.15760/mcnair.2017.01 This open access Full Issue is distributed under the terms of the Creative Commons Attribution-NonCommercial- ShareAlike 4.0 International License (CC BY-NC-SA 4.0). All documents in PDXScholar should meet accessibility standards. If we can make this document more accessible to you, contact our team. Portland State University McNair Research Journal 2017 Without Borders: Original Contributions in Undergraduate Research 2017 Ronald E. McNair Scholars Journal Portland State University 1 About the Program The Portland State University (PSU) Ronald E. McNair Scholars Program at Portland State University works with motivated and talented undergraduates who want to pursue PhDs. It introduces juniors and seniors who are first-generation and low income, and/or members of under-represented groups to academic research and to effective strategies for getting into and graduating from PhD programs. The McNair Scholars Program has academic-year activities and a full-time summer research internship. Scholars take academic and skills-building seminars and workshops during the year, and each scholar works closely with a faculty mentor on original research in the summer. Scholars present their research findings at the McNair Summer Symposium and at other conferences, and are encouraged to publish their papers in the McNair Journal and other scholarly publications. -
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