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Acepodia Receives FDA Approval for Investigational New Drug Application of ACE2016, a Pioneering Allogeneic Anti-EGFR Cell Therapy

Tuesday, February 06, 2024

Acepodia (6976:TT), a biotechnology company in the clinical stage, is pioneering novel cell therapies utilizing its Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms to tackle unmet needs in cancer care. Today, the company announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its investigational new drug (IND) application for ACE2016, an allogeneic gamma delta 2 (γδ2) T cell therapy designed for treating solid tumors expressing epidermal growth factor receptor (EGFR).

This regulatory clearance paves the way for Acepodia to commence a Phase 1 trial, marking the first-ever evaluation of the safety, tolerability, and pharmacodynamics of ACE2016 in adults with locally advanced or metastatic EGFR-expressing solid tumors. Acepodia anticipates commencing the trial in the forthcoming months and aims to administer the first dose to a patient in the latter half of 2024.

Dr. Sonny Hsiao, CEO of Acepodia, commented, "This achievement represents a significant advancement as we progress our pipeline of cutting-edge cell therapies, particularly exploring the potential of our innovative Antibody-Cell Conjugation (ACC) technology in addressing solid tumors, an area with substantial unmet medical needs in cell therapy. The rapid attainment of our third IND approval within 18 months underscores the remarkable efficiency and dedication of our team in advancing innovative programs expeditiously. With our third program entering clinical trials, we are dedicated to pushing the boundaries of cell therapy, with the aim of providing potent and accessible treatments for patients through a groundbreaking approach."

ACE2016, a candidate for off-the-shelf γδ2 T cell therapy, is developed utilizing Acepodia's proprietary ACC platform. Targeting EGFR-expressing solid tumors, ACE2016 employs antibody-conjugated γδ2 T cells to target tumors driven by the cancer-causing EGFR gene. Leveraging the advantages of ACC technology and Acepodia's proprietary γδ2 T cell platform, ACE2016 has exhibited promising cytotoxicity against various EGFR-expressing cancers in preclinical study models. The Phase 1 trial will assess the safety, tolerability, and pharmacodynamics of ACE2016 in patients with locally advanced or metastatic EGFR-expressing solid tumors, with the first patient expected to be dosed in the latter half of 2024.



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