FDA Clears Acepodia's ACE2016 IND Application

Acepodia, a clinical biotechnology company, is developing best-in-class therapeutics with its unique antibody-cell conjugate (ACC) and allergenic gamma delta 2(d2) T cells to address cancer treatment areas, one of the US. The food. And Drug Administration (FDA) and the US. The Food and Drug Administration (FDA) signed a new drug (IND) with the company for ACE2016, an allergenic gamma delta 2 (δ2) T therapies for the treatment of malignant tumors showing epidermal growth. Factor receptor (EGFR). ) The request was accepted—patients with solid tumors.

This approval allows Acepodia to initiate a first-in-human Phase 1 clinical trial evaluating the safety, tolerability and efficacy of ACE2016 in adults with local or metastatic EGFR-expressing solid tumors. Acepodia plans to start clinical trials in the coming months and treat its first patients in the second half of 2024. Cell adhesion technology (ACC) in solid tumors, which continues to be a medical necessity in cell therapy," said Sonny Hsiao, Ph.D., CEO of Acepodia.

The rapid progress in obtaining the third IND approval in less than 18 months demonstrates the team's dedication and commitment to rapidly moving innovative projects forward. With the clinic's third mission, we are proud to continue advancing the field of cell therapy to provide robust and affordable treatments to patients through first-of-a-kind approaches.

ACE2016 is a standard Δd2 T cell therapy candidate developed on the ACC and Acepodia proprietary platform. ACE2016 targets EGFR-expressing solid tumors via βd2 T cells conjugated with antibodies targeting tumors driven by the EGFR oncogenic gene. Leveraging the strengths of Acepodia's ACC technology and βd2 T-cell base, ACE2016 has demonstrated cytotoxicity against several EGFR-expressing cancers in various preclinical research models. Trial 1 will evaluate the safety, tolerability and efficacy of ACE2016 in patients with local or metastatic EGFR-expressing solid tumors. The clinical trial will deliver the first patient in the second half of 2024.