Allogene Therapeutics receives FDA RMAT designation for ALLO-316

Allogene Therapeutics (ALLO) announced that the U.S. Food and Drug Administration, FDA, granted Regenerative Medicine Advanced Therapy, RMAT, designation to ALLO-316 for the treatment of adult patients with CD70 positive advanced or metastatic renal cell carcinoma, RCC. The RMAT designation was based on clinical data from the TRAVERSE trial indicating the potential of ALLO-316 to address the unmet need for patients with difficult-to-treat RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy. The ongoing development of ALLO-316 continues to advance the scientific understanding and applicability of the Dagger(R) technology as the next-generation allogeneic platform to maximize the potential of a single infusion of “off-the-shelf” CAR T product in solid tumors.