Alameda, Calif. – September 08, 2026 -- Acepodia (6976: TT) said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for ACE723, a GPC3-targeted dual-payload antibody-drug conjugate, clearing the way for a Phase 1 clinical trial in unresectable or metastatic hepatocellular carcinoma (HCC).
FDA clearance advances first candidate from Acepodia's AD2C platform into human trials
ACE723 is built on Acepodia's proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform, which combines antibody engineering, medicinal chemistry and tumor biology to deliver two cytotoxic payloads to a single tumor-targeting antibody. The compound targets GPC3, a tumor-associated antigen frequently expressed in HCC tumor cells.
Company cites unmet need as HCC drives more than 70% of global liver cancer cases
Acepodia noted that while immunotherapy combination regimens have improved first-line HCC treatment, patients who progress or develop resistance still lack effective options, creating demand for therapies with differentiated mechanisms.
CEO and Chairman Sonny Hsiao said ACE723 is designed to address tumor heterogeneity and resistance seen with single-payload ADCs, and that the company will evaluate its safety, pharmacokinetics and preliminary anti-tumor activity in HCC patients.
Phase 1 dose-escalation study to establish safety profile ahead of expansion cohorts
The planned Phase 1 trial will assess safety, tolerability, dose-limiting toxicities, pharmacokinetics and preliminary anti-tumor activity of ACE723 in patients with unresectable or metastatic HCC. The dose-escalation stage is intended to define a recommended dose for later-stage development and potential expansion cohorts.
Parallel NMPA filing in China extends ACE723's global development track
Acepodia submitted a separate IND application for ACE723 to China's National Medical Products Administration in August 2026, part of the company's global strategy for the program.