Allogene Therapeutics' ALLO-316 Awarded FDA RMAT Designation for Advanced RCC

Allogene Therapeutics, Inc., a biotechnology company specializing in the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for its therapy ALLO-316. This designation is for the treatment of adult patients with CD70 positive advanced or metastatic renal cell carcinoma (RCC). The RMAT designation is based on clinical data from the TRAVERSE trial, which demonstrates ALLO-316’s potential to meet the needs of patients with challenging RCC who have not responded to multiple standard therapies, including immune checkpoint inhibitors and VEGF-targeting therapies.

ALLO-316, part of the AlloCAR T™ product line, employs Dagger® technology to enhance the effectiveness of a single infusion of this “off-the-shelf” CAR T product in treating solid tumors. The Dagger® technology optimizes the expansion and persistence of CAR T cells, which is crucial in treating various cancers, including hematologic malignancies and solid tumors. ALLO-316 targets CD70, a protein highly expressed in renal cell carcinoma and selectively present in other cancers.

Dr. Zachary Roberts, Executive Vice President of Research & Development and Chief Medical Officer at Allogene, highlighted the significant potential of the AlloCAR T™ platform. He emphasized that the RMAT designation represents a crucial step towards making “off-the-shelf” CAR T therapy available to patients who have exhausted conventional treatment options. This could lead to faster, more reliable, and broadly accessible treatments for patients with renal cell carcinoma.

The ongoing Phase 1 TRAVERSE trial aims to assess the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic RCC. Initial results from this trial were shared at the American Association for Cancer Research (AACR) Annual Meeting in 2023. Allogene is set to present updated Phase 1 data from the trial at the Society for Immunotherapy of Cancer (SITC) annual meeting.

The RMAT designation is designed to expedite the development and review of promising investigational products, especially in the field of cell therapies. This designation allows for early and frequent interactions with the FDA to discuss potential surrogate or intermediate endpoints and strategies to meet post-approval requirements. The goal is to streamline the path to market approval for promising therapies.

Previously, in March 2022, ALLO-316 received Fast Track Designation (FTD) from the FDA. The RMAT designation further underscores the potential of ALLO-316 to address the unmet needs of patients with advanced or metastatic RCC.

Allogene Therapeutics, headquartered in South San Francisco, is led by a team with extensive experience in cell therapy. The company is focused on developing a pipeline of “off-the-shelf” CAR T cell products with the aim of providing readily available cell therapy solutions that are more reliable and scalable, thus reaching a larger patient population.

In summary, the RMAT designation for ALLO-316 marks an important milestone in the development of new treatments for renal cell carcinoma. It offers hope for patients who have exhausted all standard treatment options and highlights the potential of Allogene’s AlloCAR T™ platform to deliver innovative and accessible therapies. The ongoing Phase 1 TRAVERSE trial and upcoming presentations at scientific meetings will provide further insights into the efficacy and safety of ALLO-316, potentially paving the way for new advancements in cancer treatment.