In an indication with few treatment options for patients who are running out of time, Replimune Group Inc. revealed positive top-line results of its lead candidate, RP-1 (vusolimogene oderparepvec), in anti-PD-1-failed melanoma. Data from the phase I/II Ignyte study of RP-1 plus Opdivo (nivolumab, Bristol Myers Squibb Co.) showed the treatment hit the primary endpoint with a 12-month overall response rate of 33.6% and a median duration of response of more than 35 months. Read More
Although the U.S. FDA unexpectedly sprang the news on Eli Lilly and Co. that it would hold an advisory committee meeting on the BLA for the company’s Alzheimer’s disease drug, donanemab, the agency’s briefing document for the June 10 meeting doesn’t appear to hold any surprises. Read More
Arrivent Biopharma Inc. and Jiangsu Alphamab Biopharmaceuticals Co. Ltd. have signed a development deal that leverages Alphamab’s antibody-drug conjugate (ADC) research and discovery platform and could bring Alphamab up to $615.5 million. Read More
Trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugates became a topic of talk during the recent American Society of Clinical Oncology meeting in Chicago. Read More
Washington-based Vanda Pharmaceuticals Inc. has faced a challenging few years involving a federal lawsuit against the U.S. FDA, patent infringement litigation, increasing generic competition and dwindling sales, as well as a complete response letter nixing plans to expand its melatonin receptor agonist Hetlioz (tasimelteon) into insomnia, yet it has recently received a higher, unsolicited acquisition offer of $466 million from a second company, Cycle Pharmaceuticals Ltd. Read More
Isotope Technologies Munich SE (ITM) raised €188 million ($204 million) in a funding round that will largely be used to advance and expand the company’s radiopharmaceutical pipeline. The funds, which come a year after ITM raised €255 million, are a sign of growing investor interest in the company’s products and the radiopharma market, Steffen Schuster, CEO of ITM, told BioWorld. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advanced Biodesign, Amgen, Aurinia, Cymabay, Gilead, Harmony, Harrow, Ose, Sparrow, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adicet, Can-Fite, Cellectis, Lykos, Myrtelle, Repare. Read More
