Acepodia's GPC3-Targeted Dual-Payload ADC ACE723 Clears FDA IND for Hepatocellular Carcinoma
核心洞察
The U.S. FDA cleared Acepodia (搜索)'s Investigational New Drug (IND) application for ACE723 (搜索), enabling initiation of a Phase 1 clinical trial.
ACE723 (搜索) is a GPC3 (搜索)-targeted dual-payload antibody-drug conjugate (ADC) developed using the proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform.
The candidate is designed to deliver two cytotoxic payloads to GPC3 (搜索)-expressing tumor cells, aiming to address tumor heterogeneity and resistance to single-payload therapies.
Acepodia (搜索) (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 its Investigational New Drug (IND) application for ACE723 (搜索), a GPC3 (搜索)-targeted dual-payload antibody-drug conjugate (ADC) for the treatment of unresectable or metastatic hepatocellular carcinoma (搜索) (HCC). The clearance enables Acepodia to advance ACE723 into Phase 1 clinical development, marking the first AD2C-generated candidate to enter the clinic.
"The FDA clearance of ACE723 (搜索) 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 (搜索). "ACE723 is designed to deliver two cytotoxic payloads to GPC3 (搜索)-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."
A Dual-Payload Approach to a Difficult Target
ACE723 (搜索) is an investigational GPC3 (搜索)-targeted dual-payload ADC developed through Acepodia (搜索)'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, providing a potential target for selective delivery of cytotoxic payloads to tumor cells.
Unlike conventional single-payload ADCs, ACE723 (搜索) is engineered to deliver two cytotoxic payloads to GPC3 (搜索)-expressing tumor cells. This dual-payload design is intended to address tumor heterogeneity and potential resistance to single-payload therapies, a key limitation in the current ADC landscape.
Unmet Need in 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 patients whose disease progresses or becomes resistant to treatment. This underscores the need for therapies with differentiated mechanisms of action, a gap that ACE723 (搜索)'s dual-payload approach aims to address.
Phase 1 Study Design
The planned Phase 1 study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics, and preliminary anti-tumor activity of ACE723 (搜索) 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.
Global Development Strategy
Acepodia (搜索) also submitted an IND application for ACE723 (搜索) to China's National Medical Products Administration (NMPA) in August 2026 as part of the Company's global development strategy for the program.
Platform Background
Acepodia (搜索)'s conjugation technology platforms leverage a family of bio-orthogonal click chemistry approaches originating from Nobel Prize laureate Carolyn Bertozzi's laboratory. The Company is advancing a pipeline based on its Antibody-Cell Conjugation (ACC) and Antibody-Dual-Drugs Conjugation (AD2C) platforms, designed to enable flexible integration across antibodies, immune cells, and payload architectures. These technologies aim to enhance targeted therapeutic activity while supporting broad applicability across hematologic malignancies, solid tumors, and autoimmune diseases.