Aceodia's ACE723 cleared for Phase 1 trial in HCC

Acepodia, a clinical-stage biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ACE723, a novel dual-payload antibody-drug conjugate (ADC) targeting GPC3-expressing tumor cells. The clearance paves the way for the company to initiate a Phase 1 clinical trial for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).

"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., CEO 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."

ACE723 is the first candidate generated through Acepodia’s proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform, which integrates expertise in antibody engineering, medicinal chemistry, and tumor biology. GPC3 is a tumor-associated antigen frequently expressed in HCC, making it a potential target for selective delivery of cytotoxic payloads to tumor cells.

Hepatocellular carcinoma (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 those whose disease progresses or becomes resistant to treatment. This underscores 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.

Additionally, Acepodia has submitted an IND application for ACE723 to China's National Medical Products Administration (NMPA) as part of the company’s global development strategy for the program.

Acepodia, which operates with the support of a modular platform combining antibodies with immune cells or therapeutic payloads, is advancing a pipeline based on its Antibody-Cell Conjugation (ACC) and AD2C platforms. These technologies are designed to enable flexible integration across antibodies, immune cells, and payload architectures, with the goal of enhancing targeted therapeutic activity while supporting broad applicability across hematologic malignancies, solid tumors, and autoimmune diseases.

By applying its conjugation technologies across multiple therapeutic modalities, Acepodia aims to develop scalable and differentiated therapies for patients with significant unmet medical needs.