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, Merck & Co. Inc.) in PD-L1-positive non-small-cell lung cancer (NSCLC). At the 2024 World Conference on Lung Cancer over the weekend, they got the detailed data from the phase III Harmoni-2 trial, which included a near doubling of progression-free survival (PFS) compared to the established blockbuster drug. Data showed median PFS of 11.14 months vs. 5.82 months, respectively, with improvement in ivonescimab’s favor across disease subtypes. Shares of Miami-based Summit (NASDAQ:SMMT) were trading up 60% at midmorning, while shares of Akeso (HK:9926) closed up nearly 16% Sept. 9.

Relay soars on first-in-human breast cancer data with PI3K drug

Shares of Relay Therapeutics Inc. (NASDAQ:RLAY) were trading at $9, up $2.76, or 44%, on word of positive interim data from the first-in-human study with RLY-2608, an investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3K alpha. The results showed that despite heavy pre-treatment, patients with PI3K alpha-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer improved significantly on treatment. They were given RLY-2608 600 mg twice daily plus fulvestrant and turned up clinically meaningful progression-free survival. Subjects chalked an objective response rate of 33% across all patients and 53% in those with kinase mutations at the recommended phase II dose. Cambridge, Mass.-based Relay said a pivotal trial is slated for next year.

Iterum: Payers part of the defense against AMR

With antimicrobial resistance (AMR) growing to many first-line drugs, a key concern in the U.S. FDA approving an oral penem like Iterum Therapeutics plc’s tablet combining sulopenem etzadroxil and probenecid is that it would become the go-to drug in treating uncomplicated urinary tract infections (uUTI) and, possibly, other infections. The worry is that such use could hasten resistance to the whole class of penem drugs, which currently is the last line of defense to AMR. Presenting for Iterum, Marjorie Golden, an infectious disease expert, addressed that concern head-on this morning, telling the FDA’s Antimicrobial Drugs Advisory Committee that insurance companies likely wouldn’t cover the oral drug, if it’s approved, without evidence that it’s needed for specific patients. Furthermore, she added, patients with uUTI who fail on a first-line treatment already are being treated with an intravenous penem.

Candid launches with bispecific antibodies and $370M in hand

San Diego-based Candid Therapeutics Inc. launched today, announcing a pair of licensing deals for two bispecific T-cell engager antibodies that it plans to develop for autoimmune diseases. The senior management team is composed of many people who were at Rayzebio Inc. when Bristol Myers Squibb Co. announced its plan to purchase the company in late 2023. Candid will start off with a pocketful of cash, having raised $370 million for the development of the in-licensed autoimmune disease candidates.

Upcoming GLP-1 player Terns piques interest with oral phase I data

Boosting shares by 27% in early trading 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 the 28-day multiple-ascending dose study, TERN-601 showed a maximum placebo-adjusted mean weight loss of 4.9%, and about 67% of participants lost 5% or more of their baseline body weight, at the highest dose of 740 mg daily. “While early, on the whole we see today’s phase I results with agonist TERN-601 supporting the molecule having a competitive clinical profile within the broader oral GLP-1 agonist landscape,” said analyst Eric Joseph, of J.P. Morgan. Terns’ shares (NASDAQ:TERN) were trading at $9.94, up $2.13, at midday.

US FDA grants fast track to Moebius-Sun’s knee OA pain injection

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. MM-II was designed as an intra-articular, large, empty, multilamellar liposome, biolubricant injection to provide symptomatic relief for patients with mild to moderate OA pain.

Also in the news

Aavantgarde, Advantage, Alnylam, Alopexx, Amneal, Apogee, Ascelia, Atsena, Bicara, Boehringer Ingelheim, Bridgebio, Cassava, Consortia, Cue, Cyclo, Diogenx, Eli Lilly, GSK, Indaptus, Ji Xing, Kalvista, Latigo, Moebius, Orsobio, Pfizer, Psyence, Shilpa, Sun, Tanvex, Theras, Travere, Zenas