Acepodia Gains FDA Clearance for ACE2016, Initiates Phase 1 Study on Solid Tumor Treatment

05 February 2024 | Monday | News

Acepodia (6976:TT), a leading clinical-stage biotechnology company specializing in novel cell therapies, announced today the U.S. Food and Drug Administration (FDA) has granted clearance for the Investigational New Drug (IND) application for ACE2016. ACE2016 is an innovative allogeneic gamma delta 2 (γδ2) T cell therapy designed to address epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors.
Image Source : Public Domain

Image Source : Public Domain

This clearance marks a significant milestone for Acepodia, allowing the initiation of a Phase 1, first-in-human clinical trial to assess the safety, tolerability, and pharmacodynamics of ACE2016 in adults with locally advanced or metastatic EGFR-expressing solid tumors. The company anticipates commencing the trial in the coming months, with the first patient expected to be treated in the second half of 2024.

Acepodia's unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms have shown promise in addressing critical gaps in cancer care. With a focus on solid tumors, which present persistent challenges in the field of cell therapy, Acepodia aims to deliver groundbreaking treatments for patients.

Sonny Hsiao, Ph.D., CEO of Acepodia, commented on the achievement, stating, "This milestone is a key step as we advance our pipeline of next-generation cell therapies and explore the potential of our novel Antibody-Cell Conjugation (ACC) technology in solid tumors, which remain unmet medical needs in the cell therapy field. The rapid progression of obtaining the third IND approval within 18 months highlights the team's remarkable efficiency and dedication to advancing innovative programs swiftly. With our third program in the clinic, we are proud to continue progressing the field of cell therapy with the goal of delivering powerful, accessible treatments for patients through a first-of-its-kind approach."

As the Phase 1 clinical trial unfolds, Acepodia remains committed to advancing the frontier of cell therapy, with the ultimate goal of offering transformative solutions for patients facing EGFR-expressing malignancies in solid tumors.


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