Acepodia announces FDA clearance of IND application for ACE723, a novel dual-payload ADC

CAR-T Digest - August 2020

04 September 2026: Acepodia announces FDA clearance of IND application for ACE723, a novel dual-payload ADC

Acepodia announced that the U.S. FDA has cleared the IND application for ACE723, a GPC3-targeted dual-payload ADC, enabling the company to initiate a phase 1 clinical trial in patients with unresectable or metastatic hepatocellular carcinoma
The planned phase 1 study will evaluate ACE723 in patients with unresectable or metastatic HCC, assessing safety, tolerability, dose-limiting toxicities, pharmacokinetics and preliminary anti-tumor activity, with dose escalation intended to establish a recommended dose for further development
The clinical development addresses a major unmet need in advanced HCC, where although immunotherapy-based combinations have improved first-line treatment, many patients eventually experience disease progression or treatment resistance, underscoring the need for therapies with differentiated mechanisms of action
ACE723 is a GPC3-targeted dual-payload ADC developed using Acepodia’s proprietary Antibody-Dual-Drugs Conjugation platform, designed to deliver two cytotoxic payloads to GPC3-expressing tumor cells with the potential to address tumor heterogeneity and resistance associated with single-payload therapies
Strategically, the FDA clearance advances the first AD2C-generated candidate into clinical development, while Acepodia’s August 2026 IND submission to China’s NMPA supports parallel global development of ACE723 and further validates its dual-payload ADC platform