Benzinga | Oct 22, 2020 07:05AM EDT

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

Phase 1 Clinical Study will Evaluate ADI-001 Safety and Efficacy in Patients with B-cell non-Hodgkin's lymphoma

MENLO PARK, Calif. and BOSTON, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Adicet Bio, Inc. (NASDAQ:ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, 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 (??) 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.

"The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR ?? T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of "off-the-shelf" ?? T cell products," said Chen Schor, President and Chief Executive Officer of Adicet. "We are particularly excited to advance on our goal to exploit the therapeutic potential of our first in class engineered CAR ?? 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.