FDA clears Adicet Bio IND application for prostate cancer therapy

Adicet Bio, Inc. (Nasdaq: ACET) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for ADI-212, a cell therapy candidate targeting metastatic castration-resistant prostate cancer (mCRPC).

According to the press release, the company plans to begin Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026.

ADI-212 is described as a gene-edited cell therapy targeting prostate-specific membrane antigen (PSMA). It incorporates membrane-tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex, designed to act within the tumor microenvironment.

Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio, said the therapy is "designed as a single off-the-shelf product" that combines "gene-editing and the expression of novel immune-stimulating molecules intended to strengthen anti-tumor potency, including improved antigen engagement, capacity for durable tumor-killing and active modulation of tumor microenvironment."

Adicet Bio is a clinical-stage biotechnology company focused on allogeneic gamma delta T cell therapies and in vivo CAR-T therapies across autoimmune diseases, hematologic malignancies, and solid tumors.

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