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Antibody News You Should Know From: The Antibody Society <[email protected]> Sent: Monday, May 6, 2019 3:00 AM To: [email protected] Subject: Antibody News You Should Know View this email in your browser Antibody News You Should Know April 15 - May 1, 2019 Antibody-based therapeutics are entering clinical study at a rate of ~120 per year, and being approved in record numbers. Recent news about relevant events are summarized below. Follow the links to find more details. New (or close!) to the clinic: Antibody-based therapeutics that recently entered clinical studies or will soon Innovent Biologics, Inc., a world-class biopharmaceutical company that develops and commercializes high quality medicines, announced that the first patient in China has been successfully dosed in a Phase I clinical trial of IBI318. IBI318 is a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and programmed cell death ligand-1 (PD-L1). Innovent Biologics, is developing IBI318 in collaboration with Eli Lilly and Company. Innovent Biologics, Inc. also announced that the first patient has been successfully dosed in a Phase I clinical trial of IBI302 as a treatment of wet age-related macular degeneration (wet AMD). Antibody News You Should Know IBI302 is a novel recombinant fully human bispecific fusion protein targeting both vascular endothelium growth factor (VEGF) and complement proteins GEMoaB Monoclonals GmbH has initiated a multicenter, open-label, dose- escalating, Phase I trial with GEM3PSCA in patients with progressive disease after standard systemic therapy in cancers with positive PSCA marker. GEM3PSCA is a prostate stem cell antigen-targeted bispecific antibody engaging T-cells Harpoon Therapeutics, Inc., a clinical-stage immunotherapy company developing a novel class of T cell engagers, announced today that the first patient has been dosed with HPN536 in a Phase 1/2a clinical trial initially focused on ovarian cancer. HPN536 targets mesothelin, which is expressed on malignant cells of ovarian and pancreatic carcinoma, mesothelioma, non-small cell lung cancer and breast cancer. HPN536 is Harpoon’s second product candidate to enter the clinic and is based on Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC™) platform. Molecular Templates, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, announced that the U.S. FDA has accepted its Investigational New Drug (IND) application for MT-5111, an ETB targeting HER2. Molecular Templates expects to start dosing in a Phase I study in relapsed/refractory patients with HER2-positive solid tumors in 3Q19. New (or close!) to the market: Antibody-based therapeutics recently approved or that may be soon The US Food and Drug Administration (FDA) approved risankizumab-rzaa (SKYRIZI) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. More information about risankizumab-rzaa and other novel drugs approved by FDA’s Center for Drug Evaluation and Research during 2019 can be found here. The European Medicines Agency’s human medicines committee (CHMP) Antibody News You Should Know recommended 13 medicines for approval at its April 2019 meeting, including cemiplimab and ravulizumab. In the EU, approvals are granted by the European Commission. Summaries of CHMP’s positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion. The CHMP recommended the granting of a conditional marketing authorisation for Libtayo (cemiplimab) for the treatment of advanced cutaneous squamous cell carcinoma. The EU orphan drug-designated medicine Ultomiris (ravulizumab) received a positive opinion from the CHMP for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria. Novartis announced that the US FDA accepted the company's biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. Seeking to make brolucizumab available as quickly as possible, Novartis used a priority review voucher to expedite FDA review. If approved by the FDA, Novartis anticipates launching brolucizumab by the end of 2019. Alder announced its BLA submission for eptinezumab, the company’s investigational monoclonal antibody for migraine prevention targeting the calcitonin gene-related peptide and lead commercial candidate, was accepted by the FDA. The FDA has set the Prescription Drug User Fee Act target action date of February 21, 2020. The BLA includes, and is supported by, positive data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials, open- label safety study, pharmacokinetic comparability study and chemistry, manufacturing, and controls data packages. Other news FDA granted supplemental approvals to Benlysta, Praluent, and KEYTRUDA. GSK announced that the US FDA has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B- lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age. The FDA has approved Praluent® (alirocumab) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in 1 Antibody News You Should Know, April 15 - May 1, 2019.htm[2/21/2020 12:29:21 PM] Antibody News You Should Know adults with established cardiovascular disease. Merck, known as MSD outside the United States and Canada, announced that the U.S. FDA has approved KEYTRUDA (pembrolizumab) in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma. The approval is based on findings from the pivotal Phase 3 KEYNOTE- 426 trial, which demonstrated significant improvements in overall survival, progression-free survival and objective response rate for KEYTRUDA in combination with axitinib (KEYTRUDA-axitinib combination) compared to sunitinib. Copyright © 2019 The Antibody Society, All rights reserved. You are receiving this email because you registered as a member of The Antibody Society on our website. Our mailing address is: The Antibody Society 247 Prospect St Framingham, MA 01701-4828 Add us to your address book Want to change how you receive these emails? You can update your preferences or unsubscribe from this list. Antibody News You Should Know - May 1-15, 2019 From: The Antibody Society <[email protected]> Sent: Monday, May 20, 2019 3:00 AM To: [email protected] Subject: Antibody News You Should Know - May 1-15, 2019 View this email in your browser Antibody News You Should Know May 1 - 15, 2019 Antibody-based therapeutics are entering clinical study at a rate of ~120 per year, and being approved in record numbers. Recent news about relevant events are summarized below. Follow the links to find more details. New (or close!) to the clinic: Antibody therapeutics that recently entered clinical studies or will soon Merus N.V. announced that the first patient has been treated in its Phase 1 trial evaluating the safety, tolerability, and preliminary efficacy of MCLA-145 for the treatment of patients with advanced solid tumors. MCLA-145 is a full-length human IgG1 bispecific antibody that targets PD-L1 and CD137. MCLA-145 is being developed in collaboration with Incyte. Xencor, Inc. announced that the first patient has been treated in a Phase 1 multiple-dose study (DUET-3) to evaluate the safety and tolerability of XmAb®23104 in patients with selected advanced solid tumors. XmAb®23104 is Antibody News You Should Know - May 1-15, 2019 a bispecific antibody that simultaneously targets the immune receptors PD-1 and ICOS. Teneobio, Inc. and its affiliate TeneoOne, Inc. announced that their investigational new drug application for TNB-383B was cleared for the initiation of Phase 1 clinical studies by the US Food and Drug Administration. TNB-383B is a fully human bispecific antibody with two binding moieties for B- cell maturation antigen on one arm and a unique anti-CD3 on the other. The ongoing development of TNB-383B is being pursued in collaboration with AbbVie, Inc. Antibody therapeutics in late-stage clinical studies AstraZeneca and Daiichi Sankyo Company, Limited announced that the pivotal Phase 2 DESTINY-Breast01 trial (NCT03248492) of the anti-HER2 antibody-drug conjugate (ADC) trastuzumab deruxtecan (DS-8201) met its primary endpoint. The ADC was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine. The study results support a global regulatory submission plan to start in the second half of 2019. MorphoSys AG and I-Mab Biopharma announced that the first patient has been dosed in a Phase 3 randomized and multi-center clinical study in Taiwan to evaluate MOR202/TJ202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma. MOR202 is an anti-CD38 human monoclonal antibody derived from MorphoSys's HuCAL antibody technology. I-Mab has exclusive rights for development and commercialization of MOR202/TJ202 in China, Taiwan, Hong Kong and Macao. First approval for netakimab On May 7, 2019, BIOCAD announced the registration of netakimab (Efleira®, BCD-085) in Russia for the treatment of moderate to iasis. Netakimab is a humanized IgG1 monoclonal antibodhe VH domain is rep aced by a Lama glama VHH domaincomplementarity-determining Antibody News You Should Know - May 1-15, 2019 egion (CDR-H3). The mAbn (IL)-17, a pro-inflammatory cytokine that plays a cr pathogenesis of psoriasis. The registration is the first for developed in Rus ia. The efficacy and safety of Efleira® in was confirmed in the Phase 3 BC -085-7/PLANETA study (NCT033conducted in 22 certified study sites in Russi and 2 stupublic of Belarus. After 12 weeks of the treatment, 83.3% of atients who received netakimab once a month after induction for the first 3 weeks achieved a 75% improvement in Psoriasis Area and Severity Index.
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