Sanofi taps Belharra for immune drug research; AstraZeneca’s new cancer drug falls short

2024-06-18

基因疗法上市批准

Today, a brief rundown of news from Belharra Therapeutics, AstraZeneca, Regenxbio and Tasyha Gene Therapies.

Sanofi will work with biotechnology startup Belharra Therapeutics to develop small molecule drugs for inflammatory diseases, the companies announced Tuesday. Belharra will get $40 million in upfront and near-term payments to start the deal, through which it will use what it describes as “next-generation chemoproteomics” to identify immune drug prospects. The alliance is the second for Belharra, which launched last year with $130 million in funding and a research pact in place with Genentech. — Ben Fidler

AstraZeneca’s bid to expand use of its new breast cancer drug Truqap has fallen short. In the Capitello-290 trial in “triple negative” breast cancer, Truqap plus chemotherapy didn’t help people live longer than did a placebo and chemotherapy. The drug is approved to treat people with hormone-receptor positive hormone-receptor positive, HER2-negative breast cancer if they have certain genetic alterations, a setting where it recorded $50 million in sales in the first quarter of 2024. The U.K.-based drugmaker expects data from a trial in prostate cancer later this year. — Jonathan Gardner

A gene therapy from Taysha Gene Therapies helped improve motor function in four people with the rare neurodevelopmental disorder Rett syndrome, the biotechnology company said Tuesday. The data are from two adult and two pediatric patients enrolled in a Phase 1/2 trial of Taysha’s therapy, called TSHA-102. One of the treated adults sat up unassisted for the first time in over a decade, while researchers observed symptom benefits in the other participants. Taysha plans to next test higher doses of its therapy. — Ned Pagliarulo

Regenxbio got agreement from the Food and Drug Administration on details of an accelerated approval application for a gene therapy the company is developing for the neurodegenerative disease Hunter syndrome. According to Regenxbio, the agency endorses the company’s plans to use a neurological protein as a surrogate marker “reasonably likely” to predict clinical benefit. It’s also discussed with Regenxbio the design of a confirmatory trial that would start next year. The biotech plans to start submitting its application in the third quarter. Dubbed RGX-121, the therapy would be its first wholly owned treatment to reach market. — Ben Fidler

The FDA has partially halted testing of an antibody-drug conjugate BioNTech licensed last year from China-based biotech MediLink Therapeutics. The FDA is concerned that higher doses of the drug, which is being evaluated against breast and lung tumors, may lead to “unreasonable and significant risk of illness and injuries,” according to a regulatory filing from BioNTech. MediLink has stopped enrolling new patients in a Phase 1 trial in the U.S. while it addresses the FDA’s concerns. — Ben Fidler

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