Clinical Biomarker Data Show Strong Tissue Trafficking and Full B Cell Depletion in Secondary Lymphoid Tissue by ADI-001

Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company in the clinical stage of discovering and developing allogeneic gamma delta T cell therapies, has reported promising clinical biomarker data from its Phase 1 GLEAN trial of ADI-001. The data highlights the potential of ADI-001 as a superior allogeneic cell therapy for autoimmune diseases. The findings were presented by Dr. Blake Aftab, Chief Scientific Officer, at the 9th Annual CAR-TCR Summit in Boston.

The GLEAN trial results revealed that ADI-001 exhibits robust tissue trafficking, leading to significant levels of chimeric antigen receptor (CAR) T cell activation and complete depletion of CD19+ B cells in secondary lymphoid tissues. These results suggest that ADI-001 could outperform existing alpha-beta CAR T therapies in targeting B cells within tissues. Dr. Blake Aftab emphasized that the trial's data supports the potential of ADI-001 to extend B cell targeting into tissues and address a wide range of autoimmune diseases.

A detailed summary of the trial results includes the following key points:
- ADI-001 showed significant CAR T cell activation and tissue exposure in lymph node biopsies, with an average exposure of 236,701 CAR T cells per million across all dose levels. This exposure ranged from 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose level, surpassing levels reported for patients treated with autologous alpha-beta CAR T therapies. The CAR T cells in tissues also displayed a robust activation profile, evidenced by in situ detection of granzyme B.
- Published studies indicate that anti-CD20 antibodies can deplete CD19+ plasmablasts, memory B cells, and naïve B cells in peripheral blood, but fail to do so within secondary lymphoid tissues. In contrast, ADI-001 demonstrated complete depletion of CD19+ B cells in secondary lymphoid tissues.
- The data suggest that ADI-001 could achieve comprehensive B-cell depletion in both peripheral blood and tissues, underscoring its therapeutic potential.

Adicet Bio is progressing the ADI-001 clinical program to treat lupus nephritis, systemic lupus erythematosus, systemic sclerosis, and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV). The company anticipates reporting initial clinical data in the first half of 2025.

The Phase 1 GLEAN trial was an open-label, multi-center study that enrolled adults with B-cell malignancies who had relapsed or were refractory to at least two prior treatment regimens. The trial aims to establish the safety, tolerability, and preliminary efficacy of ADI-001 in these patients.

Adicet Bio, Inc. is at the forefront of developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Their innovative approach involves engineering gamma delta T cells with chimeric antigen receptors to provide durable therapeutic effects. The company continues to advance its pipeline of "off-the-shelf" gamma delta T cells, aiming to offer new treatment options for patients with challenging conditions.