Acepodia Submits IND Applications for ACE723 in the United States and China

Acepodia, Inc. (Acepodia) today announced that it has submitted Investigational New Drug (IND) applications for ACE723 to the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA). ACE723 is being developed for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC). Both applications remain subject to regulatory review for the clinical trial to commence.

ACE723 is a GPC3-targeted dual-payload antibody-drug conjugate (ADC) candidate developed by Acepodia. The submissions represent an important milestone in advancing a product candidate generated through the company's proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform toward clinical development. Acepodia established its AD2C platform by integrating expertise in antibody engineering, medicinal chemistry and tumor biology. ACE723 is designed to use a GPC3-targeting antibody to deliver two cytotoxic payloads with distinct mechanisms of action to GPC3-expressing tumor cells, with the aim of addressing tumor heterogeneity and potential resistance to single-payload therapies.

HCC accounts for more than 70% of all liver cancer cases and is a common and lethal cancer worldwide, with a five-year survival rate of only approximately 22%. For advanced patients with unresectable or metastatic disease, current first-line standard treatment relies primarily on immunotherapy-based combination regimens (immunotherapy combined with an anti-angiogenic agent, or dual immunotherapy). However, current treatments still face substantial limitations; after first-line therapy fails or resistance develops, many patients face disease progression and are left without viable options, owing to the serious clinical lack of standard, effective second-line therapies. HCC is more prevalent in Asia, and as the number of liver cancer patients worldwide continues to rise, the development of innovative therapies with entirely novel mechanisms of action has become an urgent medical need, with strong clinical and commercial potential. The IND submissions in the United States and China demonstrate Acepodia's continued progress in advancing product candidates from its AD2C platform and expanding its global development activities.