Allogene's ALLO-329 Granted Three FDA Fast Track Designations

(RTTNews) - Clinical-stage biotechnology company Allogene Therapeutics, Inc. (ALLO), Monday announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Lupus, Myositis and Scleroderma,

"Receiving these designations for ALLO-329 underscores the versatility and transformative promise of this next-generation allogeneic CAR T investigational product in redefining the autoimmune treatment landscape," said Zachary Roberts, M.D., Ph.D., EVP of Research and Development and Chief Medical Officer of Allogene. "Leveraging our extensive expertise, we've developed this off-the-shelf CAR T specifically for autoimmune diseases, prioritizing both scalability and the reduction or elimination of lymphodepletion - a key barrier in this patient population."

The company expects to initiate the Phase 1 RESOLUTION basket trial in mid-2025. The trial is designed to evaluate the safety and preliminary efficacy of ALLO-329 in patients with SLE, IIM, and SSc.

This innovative trial design, which leverages the clinically validated Dagger technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone, which is used by rheumatologists, and another that eliminates lymphodepletion entirely.