BioWorld tracked 215 clinical trial readouts spanning phases I through III in December 2025, a sizeable increase from 170 updates in November, but below the 252 reported in October.
Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral gamma secretase inhibitor, hit its primary endpoint by significantly improving progression-free survival compared to placebo. The small molecule produced a statistically significant and clinically meaningful improvement vs. placebo with its 84% reduction in the risk of disease progression or death.
Researchers from Immunome Inc. and Zentalis Pharmaceuticals Inc. presented preclinical data for IM-1021, a novel tyrosine kinase-like orphan receptor 1 (ROR1)-targeted antibody-drug conjugate with a new topoisomerase 1 (TOP1) linker payload, being developed for the treatment of solid tumors and B-cell malignancies.
The deaths of two cancer patients treated with the small molecule azenosertib has prompted the U.S. FDA to place a partial clinical hold on a phase I study and two phase II studies from Zentalis Pharmaceuticals Inc. The deaths are presumed by Zentalis to be from sepsis. Both patients who died were in the phase II Denali study of platinum-resistant ovarian cancer.
Immunome Inc. gained renewed attention for its pipeline by way of the Feb. 6 deal to buy from Ayala Pharmaceuticals Inc. the phase III-stage small-molecule gamma secretase inhibitor AL-102 (plus related drug candidate AL-101).
Abbvie Inc. and Immunome Inc. have announced a worldwide collaboration and option agreement for the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome's discovery engine.
New preclinical data from Immunome Inc. gets the company closer to the clinic for studying its three-antibody cocktail’s effect on SARS-CoV-2. “We will file an IND this quarter and get into the clinic,” Immunome’s CEO, Purnanand Sarma, told BioWorld. “Since the number of cases is rising, unfortunately, we think a clinical study could be conducted reasonably quickly.”
Just months after a modest IPO, shares of Immunome Inc. (NASDAQ:IMNM) climbed 75.6% on Feb. 18, closing at $39.01. Driving the momentum was an announcement that pseudovirus testing indicates that its antibody cocktail, IMM-BCP-001, appears capable of neutralizing several SARS-CoV-2 variants, an emerging challenge to currently available vaccines and pandemic management efforts.
