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Allogene Therapeutics Receives FDA Fast Track Designation for its First Solid Tumor Candidate, ALLO-316 in the Treatment of Renal Cell Carcinoma

  • ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which Has Broad Potential Application Across a Variety of Solid Tumors and Hematologic Malignancies
  • Phase 1 TRAVERSE Trial of ALLO-316 for the Treatment of Renal Cell Carcinoma (RCC) ongoing

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., March 10, 2022 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today 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%1.

“Metastatic solid tumors have historically been a challenge to treat regardless of treatment modality, creating a large unmet need for patients and a necessity for scientific innovation,” said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. “We have our sights set on confronting solid tumors where the need is unquestionably high. We remain optimistic for the potential of our AlloCAR T platform to address the challenge and we look forward to generating data from our ongoing Phase 1 trial.”

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