Acepodia, a clinical-stage biotechnology company developing next-generation cell therapies and Antibody-Drug Conjugates (ADCs), has dosed the first patient in its Phase 1 clinical trial of ACE723 for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC). The patient was dosed at a clinical trial site in China.
ACE723 is a glypican-3 (GPC3)-targeted dual-payload ADC and the first clinical candidate developed using Acepodia's proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform.
The investigational therapy combines a GPC3-targeting antibody with two cytotoxic payloads that act through different mechanisms to kill tumour cells. The dual-payload approach is designed to address tumour heterogeneity and drug resistance that can limit the effectiveness of single-payload ADCs. GPC3 is frequently expressed in HCC, making it a potential target for delivering therapeutic payloads directly to tumour cells.
The Phase 1 study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics and preliminary anti-tumour activity of ACE723. Its dose-escalation phase is intended to establish a recommended dose for further clinical development and potential expansion cohorts.
ACE723 received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) in September 2026. The candidate subsequently received IND approval from the Taiwan Food and Drug Administration (TFDA) in October 2026, supporting its clinical development across the United States, China and Taiwan.
Commenting on the development, Sonny Hsiao, Ph.D., Chief Executive Officer and Chairman of Acepodia, said, "Dosing the first patient with ACE723 is an important moment for Acepodia. It is the first time a molecule from our AD2C platform has been given to a patient. We are grateful to the patients, investigators and site teams who made this possible, and we look forward to sharing updates as the study progresses."
HCC accounts for more than 70 percent of liver cancer cases worldwide. Although immunotherapy-based combinations have improved first-line treatment outcomes for advanced HCC, many patients eventually experience disease progression or develop treatment resistance, leaving limited subsequent treatment options. The development of therapies with alternative mechanisms of action remains an area of clinical research.
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