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

Key Terms

investigational new drug (ind) regulatory

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

mcrpc medical

mCRPC stands for metastatic castration‑resistant prostate cancer, a form of prostate cancer that has spread beyond the prostate and keeps progressing despite treatments that lower male hormones. It matters to investors because this stage is harder to treat, drives demand for new therapies, and often involves large, expensive clinical trials and regulatory decisions that can strongly influence a drug maker’s future revenue and stock value—think of it as a stubborn problem that creates both medical need and commercial opportunity.

psma medical

Prostate-specific membrane antigen (PSMA) is a protein on the surface of prostate cells that becomes much more common on many prostate cancer cells, acting like a biological “flag” that helps locate or attach to tumors. Investors care because diagnostic scans and drugs that detect or bind to PSMA can improve diagnosis and treatment; success or failure of those products often has a direct financial impact on the companies developing them.

il-12 medical

Interleukin-12 (IL-12) is a small signaling protein made by immune cells that helps turn on and direct the body’s defense system, especially the types of cells that hunt infections and cancer. For investors, IL-12 matters because drugs that boost or block it are promising targets in cancer and inflammatory disease research; changes in clinical trial results, safety signals, or regulatory views about IL-12-based therapies can strongly affect a biotech’s value, much like a thermostat that changes how a whole heating system behaves.

crispr/cas9 technical

CRISPR/Cas9 is a gene-editing technology that lets scientists locate and change specific DNA sequences inside living cells, like using a precise pair of molecular scissors guided by a GPS to cut and rewrite genetic code. It matters to investors because it underpins a fast-growing field of potential new medicines, diagnostics and improved crops; scientific breakthroughs, safety or regulatory findings, and intellectual property outcomes can quickly change the value of companies using the technology.

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Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- 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, today announced 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.

“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.

About Adicet Bio, Inc.

Adicet Bio, Inc. is a clinical-stage biotechnology company discovering and developing a broad pipeline of allogeneic gamma delta T cell therapies, engineered with chimeric antigen receptors (CARs), alongside differentiated in vivo CAR-T therapies with the potential to redefine treatment across autoimmune diseases, hematologic malignancies and solid tumors. For more information, please visit our website at https://www.adicetbio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet’s product candidates, including future plans or expectations for ADI-212 in mCRPC and the potential safety, tolerability and efficacy for the treatment of cancer; the timing of initiation of enrollment of a Phase 1 trial for ADI-212 in mCRPC; and expectations regarding the potential potency of ADI-212. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Adicet’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260827653039/en/

Adicet Bio, Inc.
Investor and Media Contacts

Anne Bowdidge
abowdidge@adicetbio.com

Penelope Belnap
Precision AQ
Penelope.belnap@precisionaq.com

Source: Adicet Bio, Inc.