Acepodia, a clinical-stage biotechnology company developing cell therapies and Antibody-Drug Conjugates (ADCs), has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for ACE723, a GPC3-targeted dual-payload ADC being developed for the treatment of unresectable or metastatic Hepatocellular Carcinoma (HCC).

The FDA clearance enables Acepodia to advance ACE723 into Phase 1 clinical development. The investigational ADC was developed using the company’s proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform, which combines antibody engineering, medicinal chemistry and tumour biology.

ACE723 is designed to target glypican-3 (GPC3), a tumour-associated antigen frequently expressed in HCC, and deliver two cytotoxic payloads to GPC3-expressing tumour cells. According to the company, the dual-payload approach is intended to address tumour heterogeneity and potential resistance associated with single-payload therapies.

The planned Phase 1 study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics and preliminary anti-tumour activity of ACE723 in patients with unresectable or metastatic HCC. The dose-escalation stage is expected to help establish the safety profile and determine a recommended dose for further clinical development.

HCC represents more than 70 percent of liver cancer cases globally. While immunotherapy-based combinations have improved first-line treatment options for unresectable or metastatic disease, treatment resistance and disease progression continue to create a need for additional therapeutic approaches.

Acepodia also submitted an IND application for ACE723 to China’s National Medical Products Administration (NMPA) in August 2026, supporting the company’s plans for global development of the programme.

The FDA clearance represents the first ACE723 candidate generated through Acepodia’s AD2C platform to enter clinical development. Further clinical evaluation will determine the safety and potential therapeutic activity of the investigational ADC in patients with advanced HCC.