Adicet Announces FDA Clearance of IND Application for First-in-Class Allogeneic CAR Gamma-Delta T Cell Therapy
“The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR γδ T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of “off-the-shelf” γδ T cell products,” said
The Phase 1 study for ADI-001 will enroll up to 80 late-stage non-Hodgkin’s lymphoma patients at a number of cancer centers across the
ADI-001 is an investigational allogeneic gamma delta T cell therapy being developed as a treatment for B-cell non-Hodgkin’s lymphoma (NHL). ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated highly potent antitumor activity in preclinical models, leading to effective long-term control of tumor growth.
Adicet is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies 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.
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 including, but not limited to preclinical and clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 and potential therapeutic effects of ADI-001, the timing and outcome of discussions with FDA and other regulatory agencies, expectations regarding the design, implementation, timing, and success of its future clinical studies of ADI-001, including whether they are pivotal or would support registration, and expectations regarding its other CAR γδ T cell therapy development activities. 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 our business and financial results, including with respect to disruptions to our 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 our 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
Investor and Media Contacts
Stern Investor Relations, Inc.
Source: Adicet Bio, Inc.