FDA clearance enables initiation of a Phase 1 clinical trial and advances the first AD2C-generated candidate into clinical development

Acepodia (6976: TT), a clinical-stage biotechnology company developing next-generation cell therapies and antibody-drug conjugates, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ACE723, a GPC3-targeted dual-payload antibody-drug conjugate (ADC) developed using Acepodia's proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC). The clearance enables Acepodia to advance ACE723 into Phase 1 clinical development.

"The FDA clearance of ACE723 marks an important milestone for our AD2C platform and brings our first AD2C-generated candidate into clinical development," said Sonny Hsiao, Ph.D., Chief Executive Officer and Chairman of Acepodia. "ACE723 is designed to deliver two cytotoxic payloads to GPC3-expressing tumor cells, with the goal of addressing tumor heterogeneity and potential resistance to single-payload therapies. We look forward to evaluating its safety, pharmacokinetics and preliminary anti-tumor activity in patients with unresectable or metastatic HCC."

ACE723 is an investigational GPC3-targeted dual-payload ADC developed through Acepodia's proprietary AD2C platform, which integrates expertise in antibody engineering, medicinal chemistry and tumor biology. GPC3 is a tumor-associated antigen frequently expressed in HCC, providing a potential target for selective delivery of cytotoxic payloads to tumor cells.

HCC accounts for more than 70% of liver cancer cases worldwide. Although immunotherapy-based combination regimens have improved first-line treatment for patients with unresectable or metastatic disease, significant unmet medical need remains for patients whose disease progresses or becomes resistant to treatment, underscoring the need for therapies with differentiated mechanisms of action.

The planned Phase 1 study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics and preliminary anti-tumor activity of ACE723 in patients with unresectable or metastatic HCC. The dose-escalation portion of the study is expected to characterize the safety profile and establish a recommended dose for subsequent clinical development and potential expansion cohorts.

Acepodia also submitted an IND application for ACE723 to China's National Medical Products Administration (NMPA) in August 2026 as part of the Company's global development strategy for the program