Allogene gets FDA IND clearance for ALLO-715, nirogacestat combo

 

• Allogene Therapeutics (ALLO +0.0%) announced that the U.S. FDA has cleared an Investigational New Drug application to study ALLO-715 in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor, in patients with relapsed or refractory multiple myeloma.
• This combination represents one of Allogene’s three strategies to target BCMA for multiple myeloma and will be deployed in the ongoing UNIVERSAL trial.
• Enrollment in this cohort is expected to begin in Q1 2021.
• Multiple myeloma is the 2nd most common hematological malignancy in the U.S, with 32,270 new cases and 12,830 deaths estimated in 2020.
• “We look forward to investigating this combination as part of our comprehensive anti-BCMA strategy aimed at optimizing cell therapy for patients with relapsed/refractory multiple myeloma.” said Rafael Amado, M.D., Executive VP of R&D and Chief Medical Officer.
• https://seekingalpha.com/news/3647067-allogene-receives-ind-clearance-from-fda-for-allominus-715-nirogacestat-combination