Bristol Myers Squibb Co. (BMS) has terminated its $1.3 billion-plus deal for Agenus Inc.’s anti-TIGIT bispecific antibody AGEN-1777 as part of a promised belt-tightening. In May 2021, BMS paid Agenus a non-refundable $200 million up-front payment in cash for the licensing, manufacturing and commercialization agreement, then a $20 million milestone payment in December 2021 and another clinical milestone payment in January 2024 for $25 million.
The possibility of a 2025 approval looks to be off the table for Actinium Pharmaceuticals Inc.’s Iomab-B, at least in the U.S. In a move that H.C. Wainwright analyst Joseph Pantginis dubbed “a major surprise,” the FDA has requested a head-to-head study demonstrating overall survival before it will consider approving the radiotherapy candidate for use in patients with active relapsed or refractory acute myeloid leukemia.
Investors wanted more from ALX Oncology Holdings Inc.’s phase II study testing evorpacept (evo) combination therapy in gastric tumors, and the stock (NASDAQ:ALXO) tumbled 36% or $1.77 to close Aug. 1 at $3.04.
Macrogenics Inc., agreeing with an independent data monitoring committee, has discontinued dosing patients in the troubled phase II Tamarack study of vobramitamab duocarmazine as a second-line treatment for metastatic castration-resistant prostate cancer.
The disappointments continue for Fibrogen Inc., which is terminating work on its once-promising anti-CTGF monoclonal antibody, pamrevlumab, after reporting missed endpoints in two late-stage pancreatic cancer studies, and cutting its workforce by about 75%.
Pepgen Inc. fell slightly short of its phase II dystrophin goal with PGN-EDO51 for patients with Duchenne muscular dystrophy (DMD) whose mutations are amenable to an exon 51-skipping approach, but Wall Street reacted in a big way, sending the Boston-based firm’s stock (NASDAQ:PEPG) down 33%, or $5.55, to close July 31 at $11.43.
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
Succeeding where others have failed in an indication with high unmet need, Celldex Therapeutics Inc. disclosed top-line data from the phase II trial with barzolvolimab (barzo) against two common forms of chronic inducible urticaria (CIndU): cold urticaria (ColdU) and symptomatic dermographism (SD).
Phase II data showing an 11.1-month improvement in overall survival for advanced ovarian cancer patients treated with the IL-12 immunotherapy IMNN-001 drove up shares of Imunon Inc. by 181% July 30. The results “could usher in the first immune-based therapy for ovarian cancer,” said Stacy Lindborg, president and CEO of the Lawrenceville, N.J.-based company.
In June 2024, BioWorld covered 221 clinical trial updates, compared to 298 in May. BioWorld recorded 23 phase III trial successes in June, seven failures, and one with mixed results.