Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Systemic Sclerosis Treatment
Friday, February 28, 2025
Adicet Bio, Inc, a biotechnology company focused on developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for ADI-001 as a potential treatment for systemic sclerosis (SSc) in adults.
Fast Track Designation is intended to support the development and accelerate the regulatory review of therapies designed to address serious conditions and meet unmet medical needs.
ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy that targets CD20 for the treatment of autoimmune diseases. The FDA has granted Fast Track Designation to ADI-001 for the treatment of relapsed or refractory class III or class IV lupus nephritis (LN), systemic lupus erythematosus (SLE) with extrarenal involvement, and systemic sclerosis (SSc). Adicet Bio is progressing ADI-001 across six autoimmune indications.
Patient enrollment for a Phase 1 study assessing ADI-001 in LN treatment is underway. Enrollment for SLE, SSc, idiopathic inflammatory myopathy (IIM or myositis), and stiff person syndrome (SPS) is scheduled to begin in the second quarter of 2025. Enrollment for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) is expected in the latter half of 2025.
In the Phase 1 GLEAN trial, ADI-001 was observed to target B-cells using an anti-CD20 CAR, showing strong exposure and complete depletion of CD19+ B-cells in both blood and secondary lymphoid tissue.
Source: adicetbio.com
