Adicet Bio, Inc. (Nasdaq: ACET) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. This designation aims to expedite the development and review of ADI-001, an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20, for a serious condition with an unmet medical need.
ADI-001: Targeting Autoimmune Diseases
ADI-001 is currently being evaluated in a Phase 1 clinical trial across six autoimmune indications. This includes ongoing enrollment for lupus nephritis (LN) and planned initiation of enrollment in the first quarter of 2025 for SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS). Enrollment for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) is expected to begin in the second half of 2025.
In the Phase 1 GLEAN trial, ADI-001 demonstrated its ability to target B-cells via an anti-CD20 CAR, showing robust exposure and complete CD19+ B-cell depletion in both peripheral blood and secondary lymphoid tissue. These findings suggest ADI-001's potential as a transformative, off-the-shelf treatment option for various autoimmune diseases.
Francesco Galimi, MD, PhD, Senior Vice President and Chief Medical Officer of Adicet Bio, stated, "ADI-001 has the potential to be a transformative off-the-shelf treatment option for several autoimmune diseases. We look forward to initiating enrollment for SLE, SSc, IIM, and SPS patients in the first quarter of 2025 and for AAV patients in the second half of 2025."
Clinical Trial Design and Endpoints
The Phase 1 study is structured with four arms: one for LN and SLE patients, one for SSc patients, one for IIM and SPS patients, and one for AAV patients. Each participant will receive a single dose of ADI-001. The primary objectives are to assess the safety and tolerability of ADI-001. Secondary endpoints include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and disease activity scores specific to each condition.
ADI-270: Advancing Solid Tumor Therapy
Adicet Bio is also making strides in oncology with ADI-270, an armored allogeneic "off-the-shelf" gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. In December 2024, the first patient was dosed in the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC).
Chen Schor, President and Chief Executive Officer at Adicet Bio, noted, "Dosing the first patient in our Phase 1 trial of ADI-270 in metastatic/advanced ccRCC is a significant milestone for Adicet as we advance our first gamma delta 1 CAR T cell product candidate for the treatment of solid tumors, one of the highest unmet needs in oncology."
Preliminary clinical data from the ADI-270 Phase 1 trial in ccRCC are expected in the first half of 2025. Preclinical data presented at the American Society of Gene and Cell Therapy (ASGCT) in April 2024 demonstrated robust anti-tumor activity in an in vivo model of ccRCC, including tumor infiltration, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting.
About Adicet Bio
Adicet Bio, Inc. is a clinical-stage biotechnology company focused on discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The company is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients.
