Adicet Bio, Inc. (Nasdaq: ACET), a clinical-stage biotechnology company focused on developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced that clinical biomarker data from the ADI-001 Phase 1 GLEAN trial will be presented in an oral session at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C. The data demonstrate robust tissue homing, significant CAR T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue, supporting the potential of ADI-001 as a treatment for autoimmune diseases.
Key Findings:
- Strong Tissue Homing & Activation: ADI-001 showed significant activation and tissue exposure in lymph node biopsies. At the 1E9 dose, CAR T cells accounted for 27-64% of total cellular material detected by ddPCR. This exceeds the levels previously reported for autologous alpha-beta CAR T therapies.
- Complete CD19+ B Cell Depletion: Along with CAR T cell activation, complete depletion of CD19+ B cells was observed in lymph node tissue, further supporting ADI-001’s potential for achieving B-cell depletion both in peripheral blood and in tissue, a limitation seen in other B-cell targeting therapies.
- Granzyme B Activation: CAR T cells demonstrated a strong activation profile, indicated by high in situ levels of granzyme B, a marker of T cell activity.
“We believe that the key to improving treatment for autoimmune diseases lies in achieving robust tissue homing, complete CD19+ B cell depletion, and superior drug exposure in secondary lymphoid tissue, all while maintaining a positive safety profile,” said Francesco Galimi, M.D., Ph.D., Chief Medical Officer at Adicet Bio. “The clinical biomarker data we are presenting at ACR Convergence 2024 supports the potential of ADI-001 to address critical unmet needs in autoimmune diseases. We are excited to move forward with a basket study of ADI-001 across six autoimmune indications, including lupus nephritis and systemic lupus erythematosus, as part of our commitment to advancing innovative therapies for patients.”
Oral Presentation Details:
- Title: ADI-001: An Allogeneic CD20-targeted γδ CAR T Cell Therapy with Potential for Improved Tissue Homing in Autoimmune Indications
- Session: Abstracts: Miscellaneous Rheumatic & Inflammatory Diseases II
- Abstract Number: 1866169
- Presenting Author: Monica Moreno, Ph.D.
- Date & Time: November 19, 2024; 12:00 p.m. – 12:15 p.m. ET
About ADI-001:
ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy targeting CD20+ B cells for the treatment of autoimmune diseases. It has received FDA Fast Track Designation for relapsed/refractory class III or class IV lupus nephritis (LN). Adicet is exploring the potential of ADI-001 in a basket study across six autoimmune indications, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), and ANCA-associated vasculitis (AAV).
About the Phase 1 GLEAN Trial:
The Phase 1 trial is designed to evaluate the safety and efficacy of ADI-001 across multiple autoimmune indications. The study has four arms: one for LN and SLE, one for SSc, one for IIM and SPS, and one for AAV. Patients in each arm will receive a single dose of ADI-001. The primary endpoints of the study include safety and tolerability, while secondary endpoints include cellular kinetics, pharmacodynamics, changes in autoantibody titers, and disease activity scores.
About Adicet Bio:
Adicet Bio, Inc. is a clinical-stage biotechnology company pioneering the development of allogeneic gamma delta T cell therapies for the treatment of cancer and autoimmune diseases. The company’s proprietary platform leverages off-the-shelf engineered gamma delta T cells to facilitate durable therapeutic activity in patients. Adicet’s pipeline includes therapies targeting B-cell malignancies, solid tumors, and autoimmune diseases.
