Allogene Therapeutics Presents Promising Phase 1 Data for ALLO-316 in Renal Cell Carcinoma

On June 1, Allogene Therapeutics Inc. (NASDAQ:ALLO) presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in advanced or metastatic renal cell carcinoma/RCC during an oral presentation at the 2025 ASCO Annual Meeting. ALLO-316 is an allogeneic CAR T product that uses Allogene’s proprietary Dagger technology to enable CAR T cell expansion.

Allogene Therapeutics Presents Promising Phase 1 Data for ALLO-316 in Renal Cell Carcinoma

A biotechnologist in a laboratory testing an Immuno-oncology treatment.

ALLO-316 has shown promise as the first allogeneic CAR T in solid tumors. The presentation focused on the Phase 1b expansion cohort of the TRAVERSE study. It included 22 heavily pretreated patients whose tumors had progressed on multiple prior therapies. Of these, 20 patients received a single dose of 80 million AlloCAR T cells following a standard cyclophosphamide and fludarabine lymphodepletion regimen. All patients had tumors resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor/TKI, with 82% having received two or more prior TKIs and 41% having received prior belzutifan. 16 of the ALLO-316-treated patients had a high CD70 Tumor Proportion Score (>50%).

The safety profile of ALLO-316 was also manageable. ALLO-316 targets CD70, which is highly expressed in RCC and other cancers. The FDA granted ALLO-316 Regenerative Medicine Advanced Therapy/RMAT designation earlier in October 2024 and Fast Track Designation/FTD in March 2023. Additionally, in April 2024, Allogene received an award from the California Institute for Regenerative Medicine/CIRM to support the ongoing TRAVERSE trial.

Allogene Therapeutics Inc. (NASDAQ:ALLO) is a clinical-stage immuno-oncology company that develops and commercializes genetically engineered allogeneic T cell therapies for the treatment of cancer and autoimmune diseases. The company has license and collaboration agreements with Pfizer Inc., Servier, Cellectis, and Notch Therapeutics Inc.

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Disclosure: None. This article is originally published at Insider Monkey.