On April 19, 2022 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, reported 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) (Press release, Adicet Bio, APR 19, 2022, View Source [SID1234612507]).

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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.