Acepodia , a clinical-stage biotechnology firm specializing in pioneering cell therapies, has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for ACE2016. ACE2016 is an allogeneic gamma delta 2 (γδ2) T cell therapy designed to target epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors. This milestone allows Acepodia to commence a Phase 1, first-in-human trial, examining the safety, tolerability, and pharmacodynamics of ACE2016 in adults with locally advanced or metastatic EGFR-expressing solid tumors. The trial is anticipated to begin in the coming months, with the first patient expected to be treated in the second half of 2024.
ACE2016, developed from Acepodia’s proprietary Antibody-Cell Conjugation (ACC) platform, utilizes off-the-shelf γδ2 T cells conjugated with antibodies to target EGFR-expressing solid tumors. The unique ACC technology enhances binding strength against tumors with low tumor antigen expression. Pre-clinical studies have demonstrated promising cytotoxicity against various EGFR-expressing cancers. Acepodia’s CEO, Sonny Hsiao, Ph.D., highlighted the significance of this achievement in advancing their pipeline of next-generation cell therapies, particularly in addressing unmet medical needs in solid tumors.
Acepodia’s ACC technology links tumor-targeting antibodies to proprietary immune cells, including natural killer and gamma delta T cells, creating novel ACE therapies. The company’s experienced leadership and scientific experts are dedicated to progressing a robust pipeline of ACE therapies with the potential to offer innovative, effective, and affordable cell therapies for a wide range of solid tumors and hematologic cancers. The rapid FDA clearance marks the third IND approval within 18 months, showcasing the company’s efficiency and commitment to advancing groundbreaking programs swiftly.