Alameda, California, USA, and Taipei, Taiwan, November 4, 2026
Acepodia, Inc., a clinical-stage biotechnology company developing next-generation cancer therapies and antibody-drug conjugates (ADCs), has announced that the first patient has been dosed in its Phase 1 clinical trial of ACE723, an investigational dual-payload antibody-drug conjugate designed to treat unresectable or metastatic hepatocellular carcinoma (HCC). The first patient received treatment at a clinical trial site in China, marking an important milestone in the company’s global clinical development strategy. ACE723 is the first clinical candidate developed using Acepodia’s proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform to enter human testing. The investigational therapy combines a glypican-3 (GPC3)-targeting antibody with two different cytotoxic drug payloads designed to attack cancer cells through distinct mechanisms. This innovative approach aims to address tumor heterogeneity and treatment resistance, which can limit the effectiveness of conventional single-payload ADC therapies. The clinical advancement represents an important step in Acepodia’s efforts to develop differentiated targeted cancer treatments for patients with significant unmet medical needs.
ACE723 Introduces a Novel Dual-Payload ADC Approach
ACE723 is a GPC3-targeted antibody-drug conjugate developed through Acepodia’s proprietary AD2C technology platform. Unlike conventional ADCs that typically deliver a single cytotoxic payload to cancer cells, ACE723 is designed to deliver two anticancer payloads with different mechanisms of action through one targeting antibody. The approach aims to improve tumor-cell killing while addressing biological differences among cancer cells that may contribute to drug resistance. GPC3 is a tumor-associated protein frequently expressed in hepatocellular carcinoma, making it an attractive molecular target for the selective delivery of anticancer agents. By binding to GPC3-expressing tumor cells, the antibody component is designed to direct the two therapeutic payloads toward cancer cells. The AD2C platform combines antibody engineering, medicinal chemistry and tumor biology to create differentiated antibody-drug conjugates. The company believes that this dual-payload architecture could offer advantages in addressing tumor heterogeneity, particularly in solid tumors where different cancer-cell populations may respond differently to conventional treatments. ACE723 represents the first clinical validation opportunity for Acepodia’s AD2C platform, as the Phase 1 study will generate initial human safety and pharmacological data.
Phase 1 Clinical Trial to Evaluate Safety and Antitumor Activity
The Phase 1 clinical trial will evaluate ACE723 in patients with unresectable or metastatic hepatocellular carcinoma, an advanced form of liver cancer. The study will initially focus on dose escalation to determine the safety and tolerability of the investigational therapy. Researchers will assess several important clinical parameters, including dose-limiting toxicities, pharmacokinetics, treatment-related adverse events and preliminary antitumor activity. The dose-escalation findings are expected to help establish a recommended dose for subsequent clinical development and potential dose-expansion cohorts. The study will also generate information about how the body absorbs, distributes and processes ACE723 following administration. These early clinical findings will be important in determining whether the dual-payload design can achieve an acceptable safety profile while demonstrating preliminary therapeutic activity. The Phase 1 trial is an early-stage investigation, and the efficacy of ACE723 has not yet been established in patients. Further clinical studies will be necessary to determine its potential benefits and risks compared with existing treatment approaches.
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Global Regulatory Clearances Support Clinical Development
Acepodia has secured regulatory authorizations supporting the clinical development of ACE723 across multiple markets. The investigational new drug (IND) application received clearance from the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) in September 2026. Subsequently, the Taiwan Food and Drug Administration (TFDA) approved the IND application in October 2026. These regulatory milestones establish a foundation for the company’s clinical development activities in the United States, China and Taiwan. The global development strategy is particularly relevant given the substantial unmet medical need associated with advanced hepatocellular carcinoma. HCC accounts for more than 70% of liver cancer cases worldwide. Although immunotherapy-based combination treatments have improved first-line management, many patients eventually experience disease progression or develop resistance, creating a need for additional therapeutic approaches. Acepodia Chief Executive Officer and Chairman Dr. Sonny Hsiao stated that the first-patient dosing represents an important achievement for the company and marks the first administration of an AD2C-generated molecule to a patient.
Overall, Acepodia’s advancement of ACE723 into Phase 1 clinical testing represents a significant milestone in next-generation antibody-drug conjugate development. The dual-payload strategy offers a differentiated approach to targeted cancer treatment, while the clinical trial will establish the initial evidence needed to evaluate its safety and therapeutic potential. Future clinical results will determine whether ACE723 can become a promising treatment candidate for patients with advanced hepatocellular carcinoma.
Source: Acepodia press release
