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Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis
Redwood City, Calif. and BOSTON, June 5, 2024 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 the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis.
The FDA's decision to grant ADI-001 Fast Track Designation for lupus nephritis underscores the urgent need for new therapies for this chronic disease, said Chen Schor, President and Chief Executive Officer of Adicet Bio. We plan to initiate our Phase 1 clinical study in lupus nephritis later this month. With clinical data for ADI-001 in non-Hodgkin's lymphoma demonstrating CD19+ B-cell depletion that mirrors data by autologous alpha-beta CAR T in academic clinical studies in several autoimmune diseases, we believe we are well positioned to expand our autoimmune program to address additional indications beyond lupus nephritis. We look forward to providing a comprehensive update on our autoimmune program to investors in the near term.
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 autoimmune diseases and cancer. Adicet is advancing a pipeline of off-the-shelf gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. 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-001; the expected progress, timing and success of the Phase 1 clinical study of ADI-001 in lupus nephritis; and the Company's expectations regarding ADI-001's potential to be effective in other indications
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