Adicet Bio gets FDA Fast Track for ADI-001 in lupus nephritis; Phase 1 starts this month

Adicet Bio, Inc.

FDA granted Fast Track Designation for ADI-001 in relapsed/refractory class III or IV lupus nephritis.
Company plans to initiate Phase 1 clinical study in lupus nephritis in June 2024.
ADI-001 previously showed CD19+ B-cell depletion in non-Hodgkin's lymphoma, similar to CAR T data in autoimmune diseases.
CEO Chen Schor cites urgent unmet need and plans to expand autoimmune program beyond lupus nephritis.

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