Daily Top News – July 28, 2020

July 28, 2020

llllllllll savolitinib (HMPL-504) / AstraZeneca, Chi-Med
Chi-Med’s NDA for Savolitinib in Non-Small Cell Lung Cancer Granted Priority Review in China (Hutchison China MediTech Press release) – Jul 28, 2020 – “Hutchison China MediTech Limited (‘Chi-Med’)…announced that the China National Medical Products Administration (‘NMPA’) has granted Priority Review status to the New Drug Application (‘NDA’) for savolitinib for the treatment of non-small cell lung cancer (‘NSCLC’) with MET Exon 14 skipping mutations. This is the first NDA filing for savolitinib globally and first for a selective MET inhibitor in China.”


llllllllll breast cancer vaccine / Anixa Biosci
Anixa Biosciences Breast Cancer Vaccine Technology Nearing FDA Submission (PRNewswire) – Jul 28, 2020 – “Anixa Biosciences, Inc…announced that its prophylactic breast cancer vaccine is making progress towards clinical trials…Anixa and Cleveland Clinic intend to file the Investigational New Drug (IND) Application with the US Food and Drug Administration by the end of the current quarter.”


llllllllll CTI-1601 / Larimar Therap
Larimar Therapeutics Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency for CTI-1601 for the Treatment of Friedreich’s Ataxia (GlobeNewswire) – Jul 28, 2020 – “Larimar Therapeutics, Inc….today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company’s application for orphan drug designation for CTI-1601, a potential treatment for Friedreich’s ataxia (FA)….Larimar expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) this year….’We look forward to working closely with EMA and continuing our U.S. Phase 1 trial of CTI-1601….We remain on track to report topline data in the first half of 2021.'”


llllllllll BDTX-189 / Black Diamond Therap
Black Diamond Therapeutics Granted Fast Track Designation by the FDA for BDTX-189 for the Treatment of Adult Patients with a Solid Tumor Harboring an Allosteric HER2 Mutation or an EGFR or HER2 Exon 20 Insertion Mutation (GlobeNewswire) – Jul 28, 2020 – “Black Diamond Therapeutics…announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric human epidermal growth factor receptor 2 (HER2) mutation or an epidermal growth factor receptor (EGFR) or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options. BDTX-189, an orally available, irreversible small molecule inhibitor, is the Company’s lead product candidate designed to selectively inhibit the activity of a broad range of previously unaddressed oncogenic driver mutations of the ErbB kinases in EGFR and HER2.”

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