Cendakimab

Bristol Myers Squibb is ending work on a handful of assets, including an immunology medication that was in two Phase 3 trials. The pipeline cuts disclosed Thursday follow news of a wider $2 billion cost-saving initiative , the pharma’s second large restructuring in less than a year. Those reductions are set to impact the workforce and operating costs involving marketing, clinical trials and supply chains. The most consequential pipeline decision was culling cendakimab, an IL-13 inhibitor that was in two Phase 3 studies to treat esophagus and gastrointestinal inflammation, respectively. Chief commercialization officer Adam Lenkowsky told analysts on the company’s earnings call that “we’ve made the decision not to commercialize cendakimab.” A readout last year from the drug’s pivotal study in eosinophilic esophagitis found that it hit both of its primary endpoints, with statistically significant reductions in white blood cell counts in the esophagus and patients reporting fewer instances of food getting stuck in their throats. Bristol Myers did not expand on a commercialization timeline when it reported the data in late July. The Sotyktu makers are also putting plans for a backup TYK2 asset on ice, according to medical chief Samit Hirawat, saying the priority is commercializing the first-gen product. “At the current time, our focus is truly squarely on Sotyktu and maximizing that opportunity from a development and commercial perspective,” he told analysts. The second-generation candidate, BMS-986322, wrapped up a Phase 2 study in patients with moderate-to-severe psoriasis in August 2024, according to the clinical trial record . Hirawat said that it’s no longer currently in development. A smattering of other Phase 1 drugs were culled as well, including two solid tumor drugs, an NK cell engager to treat leukemia, and another TYK2 inhibitor aimed at neuroinflammatory conditions. BMS also removed an obstructive hypertrophic cardiomyopathy indication for MYK-224, a drug acquired from MyoKardia. A spokesperson for Bristol Myers confirmed the pipeline cuts, saying “as a standard practice, we regularly evaluate our pipeline to ensure we are prioritizing the assets that will have the greatest clinical benefit to impact areas of high unmet need and where BMS can deliver these medicines.” The changes, and select explanations by execs, further demonstrate BMS’ effort to double down on its existing portfolio — and invest in and maximize revenue from those medicines. Schizophrenia drug Cobenfy, the prize drug from BMS’ acquisition of Karuna Therapeutics, was in the spotlight after earning $10 million in its first two months on the market, in line with investor expectations, according to Leerink analysts. The company said they’re tracking ahead of expectations on access for patients on Medicare and Medicaid, which combined represent about 80% of the covered patients that BMS is targeting. A ramp-up is expected in the back half of 2025. Lenkowsky said that feedback from prescribers has been positive, and that most are starting patients on the lowest 50 mg dose and taking “a week or two” before titrating up to the next dose, which is likely mitigating GI side effects. Instructions for Cobenfy ask that patients take it at least one hour before a meal or two hours after, but a study testing the drug with food is set to read out this year. Lenkowsky said that should make it even easier to prescribe.

Axing alnuctamab gets Bristol Myers Squibb out of the competitive BCMA bispecific space, which is already served by Johnson & Johnson’s Tecvayli and Pfizer’s Elrexfio. Bristol Myers Squibb has had a whiplash change of heart on its BCMA bispecific T-cell engager, halting (PDF) further development months after filing to run a phase 3 trial. The Big Pharma disclosed the change of plan alongside a phase 3 win for a potential challenger to Regeneron, Sanofi and Takeda.BMS added a phase 3 study of the bispecific, alnuctamab, to ClinicalTrials.gov in January. At the time, the company planned to enroll 466 patients to show whether the candidate could improve progression-free survival in people with relapsed or refractory multiple myeloma. However, BMS abandoned the study within months of the initial filing.The drugmaker withdrew the study in May, on the grounds that “business objectives have changed,” before enrolling any patients. BMS delivered the final blow to the program in its second-quarter results Friday when it reported an impairment charge resulting from the decision to discontinue further development.A spokesperson for BMS framed the action as part of the company’s work to focus its pipeline on assets that it “is best positioned to develop” and prioritize investment in opportunities where it can deliver the “highest return for patients and shareholders.” Alnuctamab no longer meets those criteria. “While the science remains compelling for this program, multiple myeloma is an evolving landscape and there are many factors that must be considered when prioritizing to make the biggest impact,” the BMS spokesperson said. The decision comes shortly after recently installed BMS CEO Chris Boerner began a $1.5 billion cost-cutting program.Axing alnuctamab gets BMS out of the competitive BCMA bispecific space, which is already served by Johnson & Johnson’s Tecvayli and Pfizer’s Elrexfio. Physicians can also choose from other modalities that target BCMA, including BMS’ own CAR-T cell therapy Abecma. BMS’ multiple myeloma pipeline is now focused on the CELMoD agents iberdomide and mezigdomide and the GPRC5D CAR-T BMS-986393.BMS also used its second-quarter results to report that a phase 3 trial of cendakimab in patients with eosinophilic esophagitis met both co-primary endpoints. The antibody hits IL-13, one of the interleukins targeted by Regeneron and Sanofi’s blockbuster Dupixent. The FDA approved Dupixent in the indication in 2022. Takeda’s once-rejected Eohilia won approval in the setting in the U.S. earlier this year.Cendakimab could give physicians a third option. BMS said the phase 3 study linked the candidate to statistically significant reductions versus placebo in days with difficult swallowing and counts of the white blood cells that drive the disease. Safety was consistent with the phase 2 trial, according to BMS.