Allogene Therapeutics, Inc. announced that it has received a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of ALLO-316, an AlloCAR T? investigational product targeting CD70 in development for the treatment of advanced or metastatic renal cell carcinoma (RCC). The grant will support the ongoing Phase 1 TRAVERSE trial which assesses safety, tolerability and preliminary efficacy of ALLO-316 in advanced RCC that has progressed despite standard therapy. Initial data from the TRAVERSE trial, presented at AACR 2023, showed promising response rates and early anti-tumor activity with deepening responses over time in participants with a marked unmet medical need.

In the TRAVERSE trial, ALLO-316 has demonstrated the potency of the Dagger® technology, which selectively eliminates CD70 positive, alloreactive host immune cells, thus delaying or preventing premature rejection of AlloCAR T cells by the patient?s immune system. ALLO-316 has shown marked expansion and persistence both in preclinical experiments and in clinical trial patients, even when combined with comparatively less-intense lymphodepletion regimens. The intent of this grant will be to facilitate completion of the Phase 1 portion of the trial, including expansion of clinical sites to increase access for diverse patient populations.

Additionally, the grant will support translational and clinical analyses to inform a recommended Phase 2 regimen. Details on a potentially cornerstone safety algorithm discovered during the initial portion of the Phase 1 TRAVERSE trial, which may facilitate expanded use of CAR Ts in solid tumors, is planned for a publication in second quarter 2024. A more comprehensive data update from the ongoing trial is planned for later in 2024.