Adicet Bio Announces FDA Clearance of IND Application for ADI-212

On August 27, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and in vivo CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026.

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"ADI-212 marks an important milestone in Adicet’s strategy to address the complexity of solid tumors and represents an important addition to our portfolio of allogeneic gamma delta 1 cell therapies and in vivo CAR T programs," said Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio. "Designed as a single off-the-shelf product, ADI-212 incorporates multiple platform enhancements by combining 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. The successful IND clearance reinforces our commitment to advancing innovative therapies for patients with cancer."

About ADI-212

ADI-212 is a next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA), engineered to express a novel CAR binder designed to enhance tolerability and tumor specific recognition. The program combines membrane-tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex (MED12) designed to improve potency in solid tumors and enable multiple anti-tumor mechanisms within the tumor microenvironment.

(Press release, Adicet Bio, AUG 27, 2026, View Source [SID1234670384])