Like the first death reported in March, Sarepta Therapeutics attributed the fatality to a case of acute liver failure following dosing of the Duchenne muscular dystrophy gene therapy, Elevidys. The company has proposed an immunosuppressive regimen to mitigate the liver injury risk posed by the therapy.
Bristol Myers Squibb’s new multibillion-dollar partnership in a hot area of cancer research overshadowed many of the announcements at the recent annual meeting of the American Society of Clinical Oncology in Chicago. We covered that news and other developments from the largest cancer conference in the world.
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Bristol Myers Squibb is licensing global rights to a Philochem program in development for both diagnostic imaging and targeted treatment of prostate cancer. It follows the pharma giant’s entry into radiopharmaceuticals via the $4.1 billion acquisition of RayzeBio last year.
FDA approval of Merck’s RSV antibody drug, Enflonsia, makes it a direct competitor to Sanofi’s Beyfortus. The new Merck product is expected to be discussed by the CDC’s Advisory Committee on Immunization Practices; ACIP will have an entirely new roster at its next meeting after all 17 sitting members were dismissed by Health and Human Services Secretary Robert F. Kennedy Jr.
Novo Nordisk, AbbVie, and Roche each have weekly injectable drug candidates designed to bind to and activate the amylin receptor to trigger weight loss. Metsera’s contender, MET-233i, is designed with technology that enables longer dosing intervals and the company is proceeding with development of this engineered peptide as a monotherapy and as part of a drug combination.
Johnson & Johnson has projected its lung cancer drug Rybrevant could achieve $5 billion in peak revenue. At the recent ASCO annual meeting, J&J executive Joshua Bauml explained his company’s strategy for this drug in lung cancer and beyond.
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Eli Lilly is partnering with Camurus, a company with technology that extends how long an injectable drug lasts in the body, permitting longer dosing intervals. Lilly plans to apply the technology to its metabolic medicines; the deal follows a similar move Novo Nordisk starting an alliance with Ascendis.
Kura Oncology’s ziftomenib addresses a specific genetic mutation present in about 30% of cases of acute myeloid leukemia. Data from the drug’s pivotal Phase 2 test were presented during the annual meeting of the American Society of Clinical Oncology.
Bristol Myers Squibb’s partnership with BioNTech makes it the third big pharma company to strike a deal to gain access to a PD-L1/PD-1 and VEGF bispecific antibody with potential use in drug combinations to treat cancer. The deal calls for the two companies to share in the development of BioNTech’s drug and co-commercialize the asset globally.
Merck KGaA’s pimicotinib led to statistically significant improvement on multiple measures of its Phase 3 test in tenosynovial giant cell tumor, positioning the drug to potentially compete with medications from Daiichi Sankyo and Ono Pharma. The Phase 3 results were presented during the annual meeting of the American Society of Clinical Oncology.
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Astellas Pharma gets global rights to an Evopoint Biosciences antibody drug conjugate that targets Claudin 18.2. Last year, Astellas’s antibody drug Vyloy became the first FDA-approved therapy for this target.
Pfizer drug Braftovi achieved statistically significant and clinically meaningful improvement in overall survival for colorectal cancer patients in a Phase 3 clinical trial. The results will be presented Friday during the annual meeting of the American Society of Clinical Oncology.
Messenger RNA technology offers a faster way to develop vaccines to address or prepare for pandemics, and Moderna’s vaccine candidate for avian influenza is on track for Phase 3 testing. But the Department of Health and Human Services has canceled a $590 million contract to support Moderna's pivotal trial.
Rocket Pharmaceuticals adjusted the clinical trial design to include use of approved drug to avert an excessive immune response to its Danon disease gene therapy. The patient who died was one of two who received this drug under the revised protocol.
Eli Lilly’s acquisition of SiteOne Therapeutics comes ahead of Phase 2 testing of the startup’s lead drug candidate, which blocks the NaV1.8 sodium channel to treat pain. This target has clinical and regulatory validation from the recent FDA approval of Vertex Pharmaceuticals’ pain drug, Journavx.