Adicet Bio receives FDA fast track designation for ADI-001 in Lupus Nephritis

Adicet Bio nnounced 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.