Adicet Bio Granted FDA Fast Track Status for ADI-001 in Treatment of Refractory Systemic Lupus Erythematosus with Extrarenal Involvement
Thursday, February 06, 2025
Adicet Bio, Inc a clinical-stage biotechnology company focused on discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001. This designation applies to the potential treatment of adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement.
The Fast Track Designation process is designed to speed up the development and review of drugs aimed at treating serious conditions with unmet medical needs.
ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for autoimmune diseases. The FDA has granted ADI-001 Fast Track Designation for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN) and SLE with extrarenal involvement. The company is advancing ADI-001 across six autoimmune conditions, with ongoing patient enrolment in the Phase 1 study evaluating ADI-001 for the treatment of LN. Enrolment for SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM or myositis), and stiff person syndrome (SPS) is expected to begin in the first quarter of 2025, with enrolment for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) expected to start in the second half of 2025. In the Phase 1 GLEAN trial, ADI-001 was shown to target B-cells through an anti-CD20 CAR, demonstrating strong exposure and complete CD19+ B-cell depletion in both peripheral blood and secondary lymphoid tissue.
Source: adicetbio.com
