Adicet Bio receives FDA clearance for prostate cancer trial
Redwood City, Calif. - Adicet Bio Inc. announced on Wednesday that the FDA has approved its Investigational New Drug application for ADI-212, a treatment for advanced prostate cancer. ADICET Bio plans to initiate Phase 1 enrollment of patients with metastatic castration-resistant prostate cancer in the fourth quarter of 2026. ADI-212 is a gene-edited cell therapy candidate targeting the prostate-specific membrane antigen.
This treatment consists of a CAR binder designed to recognize tumors, combined with membrane-tethered IL-12 and CRISPR/Cas9-mediated modification of subunit 12 of the mediator complex. Blake Aftab, Adicet Bio's Chief Scientific Officer, noted that ADI-212 is a significant milestone in the company's approach to tackling solid tumors and adds to their portfolio of allogeneic gamma delta 1 cell therapies and in vivo CAR T programs.
The FDA clearance enables Adicet Bio to advance to clinical trials in humans, where Phase 1 trials will focus on the safety and dosage of the new treatment.
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