Research & Development
Acepodia's ACE2016 IND application receives US FDA approval
5 February 2024 -

Acepodia (6976:TT), a California-based clinical stage biotechnology company, announced on Sunday that it has received approval from the US Food and Drug Administration for the company's investigational new drug (IND) application for ACE2016, an allogeneic gamma delta 2 T cell therapy, intended for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumours.

The approval allows the company to commence a Phase one, first-in-human trial assessing the safety, tolerability and pharmacodynamics of ACE2016, in adults with locally advanced or metastatic EGFR-expressing solid tumours. The company is expected to commence the trial in the coming months and treat the first subject in the second half of 2024.

The product is an off-the-shelf gamma delta 2 T cell therapy candidate developed from Acepodia's proprietary ACC platform.

Sonny Hsiao, Ph.D., Acepodia chief executive officer, said, '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 tumours, which remain to be 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.'