Allogene Therapeutics to present data on ALLO-316 at IKCS, SITC meetings

Allogene Therapeutics (ALLO) will present new data from the ongoing Phase 1 TRAVERSE trial at the 2024 International Kidney Cancer Symposium and the Society for Immunotherapy of Cancer’s annual meeting. The trial evaluates ALLO-316, the Company’s first AlloCAR T product candidate for the potential treatment of solid tumors. These presentations will highlight data from 26 heavily pretreated patients with CD70 positive renal cell carcinoma and will include details on the diagnostic and treatment algorithm used to mitigate treatment-associated hyperinflammatory response seen in some patients. The ongoing Phase 1 data supported the U.S. Food and Drug Administration’s October 2024 decision to grant Regenerative Medicine Advanced Therapy designation for ALLO-316 based on clinical data from the TRAVERSE trial indicating its to address the unmet need for adult patients with advanced or metastatic CD70 positive RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy. “We are looking forward to presenting the most recent Phase 1 data from our ongoing TRAVERSE trial at both SITC and IKCS,” said Zachary Roberts, M.D., Ph.D., EVP of Research & Development and Chief Medical Officer. “There is significant unmet need for these heavily pretreated patients with advanced RCC. In treating their disease, these patients rarely get any form of treatment break as their disease quickly progresses. This data highlights the potential of ALLO-316 to elicit a response from a single infusion, suggesting a breakthrough in allogeneic CAR T therapy for solid tumors. As the Phase 1 data matures, we plan to seek FDA’s input for the next stage of clinical development.” The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic RCC. The development of ALLO-316 continues to advance the scientific understanding and applicability of the Dagger technology as the next-generation allogeneic platform with the ability to maximize the potential of a one-time infusion. In April 2024, the Company announced a $15 million award from the California Institute for Regenerative Medicine to support the ongoing TRAVERSE trial with ALLO-316 in RCC.