-

Adicet Bio Receives FDA Fast Track Designation for Lead Candidate ADI-001

MENLO PARK, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead program ADI-001, an investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).

ADI-001 is currently being evaluated in an ongoing dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001 for the potential treatment of NHL. The Fast Track Designation was granted based on ADI-001’s potential to address an unmet need within the adult NHL patient population.

“Fast Track Designation represents an important milestone in the clinical development of ADI-001,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “We believe ADI-001 is unique in that it is designed to target malignant B cells by leveraging the innate and adaptive receptors found naturally on gamma delta T cells with the added benefit of an engineered anti CD20 CAR. We remain optimistic about the potential of our program and look forward to reporting additional data from the Phase 1 trial of ADI-001 in the first half of 2022.”

Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.

About Adicet Bio, Inc.

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with CAR and T cell receptor-like targeting moieties to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. For more information, please visit our website at http://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 business and operations of Adicet. These forward-looking statements include, but are not limited to, express or implied statements regarding Adicet’s beliefs and expectations regarding: the expected potential therapeutic effects, safety and tolerability profile, design, implementation, timing, and success of ADI-001; and the significance and expected benefits of FDA’s Fast Track Designation for ADI-001.

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 COVID-19 on Adicet’s business and financial results, including with respect to disruptions to Adicet’s clinical trials, business operations, and ability to raise additional capital; Adicet's ability to execute on its strategy; that positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; future 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; regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; regulatory developments in the United States and foreign countries; and the company's estimates regarding expenses, future revenue, and capital requirements. 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 entitled "Risk Factors" in Adicet's most recent annual report on Form 10-K and periodic reports on Form 10-Q and Form 8-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Adicet's other filings with the SEC. 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.

Contacts

Adicet Bio., Inc.
Investor and Media Contacts
Anne Bowdidge
abowdidge@adicetbio.com

Janhavi Mohite
Stern Investor Relations, Inc.
212-362-1200
janhavi.mohite@sternir.com

Adicet Bio, Inc.

NASDAQ:ACET

Release Versions

Contacts

Adicet Bio., Inc.
Investor and Media Contacts
Anne Bowdidge
abowdidge@adicetbio.com

Janhavi Mohite
Stern Investor Relations, Inc.
212-362-1200
janhavi.mohite@sternir.com

More News From Adicet Bio, Inc.

Adicet Bio Reports First Quarter 2025 Financial Results and Provides Business Updates

REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the first quarter ended March 31, 2025. “We are approaching an exciting inflection point for our pipeline, with significant data milestones on the horizon,” said Chen Schor, President and Chief Executive Officer...

Adicet Bio Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced it granted inducement awards on April 30, 2025. Three individuals were hired by Adicet in April 2025. In the aggregate, Adicet granted new hires non-qualified stock options to purchase 206,800 shares of Adicet’s common stock with an exercise price of $0.66 per...

Adicet Bio to Participate in a Fireside Chat at the Citizens JMP Life Sciences Conference

REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the 2025 Citizens JMP Life Sciences Conference being held from May 7-8, 2025 in New York. Details of the event are as follows: Date: Wednesday, May 7, 2025 Time: 1:3...
Back to Newsroom