Allogene Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to ALLO-316, the Company's first AlloCAR T solid tumor clinical candidate for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma (RCC). The FDA granted FTD based on the potential of ALLO-316 to address the unmet need for patients with difficult to treat renal cell carcinomas (RCC) who have failed standard RCC therapies. RCC is a disease in need of innovation as current therapies are based on a few mechanistic targets and complete response rates are low.

The five-year survival rate for patients with advanced kidney cancer is less than 15%. ALLO-316 targets CD70, which is highly expressed in RCC with limited normal tissue expression, making it an attractive CAR T. CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC.

Fast Track designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available.