FDA Grants Fast Track to Adicet Bio's ADI-001 for Refractory SLE Treatment

REDWOOD CITY, Calif. & BOSTON—February 5, 2025—Adicet Bio, Inc. has announced a significant advancement in its work on therapies for autoimmune diseases and cancer. The company, known for its clinical-stage biotechnology innovations, revealed that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its ADI-001 therapy. This designation is particularly for its potential use in treating adults with refractory systemic lupus erythematosus (SLE) exhibiting extrarenal involvement.

Fast Track Designation is an FDA process aimed at expediting the development and review of drugs intended to address serious conditions and fill unmet medical needs. This recognition is pivotal for ADI-001, which is being investigated as an allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy, specifically targeting CD20 to treat autoimmune diseases. The therapy was also previously recognized with Fast Track Designation for managing relapsed or refractory lupus nephritis (LN) in classes III and IV, alongside its application for SLE with extrarenal manifestations.

The company has been actively advancing ADI-001 across six autoimmune indications. Currently, patient enrollment is underway for a Phase 1 study evaluating its efficacy in treating lupus nephritis. Additionally, the company plans to initiate patient enrollment for SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), commonly known as myositis, and stiff person syndrome (SPS) within the first quarter of 2025. Further, enrollment for patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) is anticipated to start in the latter half of 2025. The Phase 1 GLEAN trial has showcased ADI-001's ability to effectively target B-cells through an anti-CD20 CAR, demonstrating robust exposure and complete depletion of CD19+ B-cells in both peripheral blood and secondary lymphoid tissue.

Adicet Bio, Inc. has established itself as a leader in the discovery and development of allogeneic gamma delta T cell therapies. Their focus on "off-the-shelf" gamma delta T cells engineered with CARs is designed to provide durable activity in patients, marking a significant step forward in biotechnology and therapeutic development.