More than three months ago, investors first learned that ivonescimab, a PD-1/VEGF-targeting bispecific antibody from Summit Therapeutics and Akeso Pharmaceuticals Inc., bested Keytruda (pembrolizumab) in PD-L1-positive non-small-cell lung cancer (NSCLC). At the 2024 World Conference on Lung Cancer over the weekend, Summit rolled out detailed data from the phase III Harmoni-2 trial, which included a nearly doubling of progression-free survival for ivonescimab compared to Merck & Co. Inc.’s established blockbuster drug. Read More
With positive first-in-human findings on board, Relay Therapeutics Inc. plans a pivotal study next year to test RLY-2608, an allosteric, pan-mutant and isoform-selective inhibitor of PI3K alpha in breast cancer. During a conference call on the data, TD Cowen analyst Yaron Werber noted that “next year’s going to be a pretty busy year for you. How fast can you start the phase III? Is there any way to pull it into the first half of the year as opposed to the second half?” CEO Sanjiv Patel said the company is “moving as fast as we possibly can,” and an update will be provided once a sit-down with regulators is finished. Read More
With antimicrobial resistance growing to many first-line antibiotics, a key concern in the U.S. FDA’s approving an oral penem like Iterum Therapeutics International Ltd.’s tablet combining sulopenem etzadroxil and probenecid is that it could become a first-line, go-to drug in treating uncomplicated urinary tract infections and, possibly, more serious infections off-label. Read More
Candid Therapeutics Inc. launched with ex-China control of two bispecific T-cell engager antibodies that it plans to develop for autoimmune diseases. The San Diego-based company will start off with a pocketful of cash, having raised over $370 million for the development of the in-licensed candidates. Read More
Boosting shares by nearly 17% on Sept. 9, phase I data of Terns Pharmaceuticals Inc.’s glucagon-like peptide 1 (GLP-1) receptor agonist, TERN-601, demonstrated it was well-tolerated and led to a statistically significant weight loss across all three doses tested in healthy adults who were obese or overweight. Read More
The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016. Read More
New hires and promotions in the biopharma industry, including: Aavantgarde, Advantage, Apogee, Cassava, Cue, Diogenx, Eli Lilly, Latigo, Theras. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atsena, Boehringer Ingelheim, GSK, Kalvista, Milestone. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alnylam, Bora Biologics, Clairvoyant, Bridgebio, Pfizer, Psyence, Tanvex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Moebius, Shilpa, Sun Pharmaceutical, Travere. Read More
