Today, a brief rundown of news involving Allogene and Agios Pharmaceuticals, as well as updates from AbbVie, AstraZeneca and BridgeBio Pharma that you may have missed.
Allogene CEO David Chang will step aside following an eight-year run, the company announced Thursday. Chang co-founded Allogene after serving as an executive at Kite Pharma, a cell therapy maker Gilead Sciences acquired in 2017. The firm then raised hundreds of millions of dollars in private and public funding and, after a series of ups and downs, brought a donor-derived cell therapy for lymphoma into late-stage testing. Current research chief and Chief Medical Officer Zachary Roberts will take over as Allogene’s leader on July 1. Chang will continue to serve on Allogene’s board.
An experimental drug Agios Pharmaceuticals has positioned as a “next-generation” version of its marketed medicine Pyrukynd, has failed a mid-stage trial. According to Agios, the drug, tebapivat, fell short in a study in lower-risk myelodysplastic syndromes and won’t be developed further in that indication. A Phase 2 study is still underway in sickle cell disease, however, with results expected later this year. Tebapivat activates an enzyme that’s critical to the function of red blood cells, as Pyrukynd does. But the drug is structured differently and designed to provide “optimized clinical benefits,” Agios said.
AbbVie has won a U.S. clearance for a medicine it acquired in a $10 billion buyout of antibody-drug conjugate specialist ImmunoGen three years ago. Known as Decnupaz, the therapy has been cleared for use in people with blastic plasmacytoid dendritic cell neoplasma, an ultra-rare and fast-moving blood cancer with few treatment options. The clearance makes Decnupaz the third marketed ADC for AbbVie and its first for a blood malignancy. In testing, about 70% of treatment recipients had no detectable signs of cancer afterwards.
The FDA also on Thursday greenlit AstraZeneca’s immunotherapy Imfinzi as a treatment for a type of bladder tumor. The clearance enables use of Imfinzi alongside another immune-boosting treatment, Bacillus Calmette-Guérin, in people with the “non-muscle invasive” form of bladder cancer. The approval was based on study results published in The Lancet last year which showed that people highly likely to relapse or see their disease progress had a 32% reduction in the risk of those outcomes, as well as death, after a year.
Additionally, the agency has begun reviewing an experimental treatment BridgeBio Pharma has developed for a form of limb-girdle muscular dystrophy. The drug, BBP-418, is being evaluated as a treatment for the “type 2I/R9” form of limb-girdle, for which there are no marketed treatments. It’s also one of a few BridgeBio rare disease therapies now nearing an approval following a string of clinical successes. The FDA is expected to make a decision on BBP-418 by Nov. 27.
