Adicet Announces FDA Clearance of IND Application for First-in-Class Allogeneic CAR Gamma-Delta T Cell Therapy

Adicet Bio today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-001, an allogeneic gamma delta (γδ) T cell therapy expressing a chimeric antigen receptor (CAR) targeting CD20 for treatment of non-Hodgkin’s lymphoma (NHL). The active IND enables the Company to initiate the first-in-human clinical trial to assess safety and efficacy of ADI-001 in NHL patients.

Chen Schor, President and Chief Executive Officer of Adicet Said: “The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR γδ T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of “off-the-shelf” γδ T cell products, We are particularly excited to advance on our goal to exploit the therapeutic potential of our first in class engineered CAR γδ T cell therapy in NHL patients. We believe that ADI-001 offers the opportunity for on demand treatment, selective tumor targeting, innate and adaptive anti-tumor immune response, and durable activity in patients. We look forward to advancing our product pipeline to address additional solid and hematologic tumors.”

The Phase 1 study for ADI-001 will enroll up to 80 late-stage non-Hodgkin’s lymphoma patients at a number of cancer centers across the U.S. The study includes a dose finding portion followed by dose expansion cohorts to explore the activity of ADI-001 in multiple subtypes of NHL. Site initiation activities are underway and interim clinical data from this study are expected in 2021.

About ADI-001         

ADI-001 is an investigational allogeneic gamma delta T cell therapy being developed as a treatment for B-cell non-Hodgkin’s lymphoma (NHL). ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated highly potent antitumor activity in preclinical models, leading to effective long-term control of tumor growth.

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