19.04.2022 13:48:31
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Adicet Bio's Lead Candidate ADI-001 Gets FDA Fast Track Designation - Quick Facts
(RTTNews) - Adicet Bio, Inc. (ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor or CAR T cell therapies for cancer, Tuesday said the U.S. Food and Drug Administration has granted Fast Track Designation to its lead program ADI-001.
It is an investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma or 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 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.
Chen Schor, President and Chief Executive Officer of Adicet Bio, said, "Fast Track Designation represents an important milestone in the clinical development of ADI-001... 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."
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