As reported on PharmaBiz, the US Food and Drug Administration (FDA) has authorized Acepodia to proceed with clinical testing of ACE723, an investigational antibody-drug conjugate (ADC) designed for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The regulatory clearance of the company’s Investigational New Drug (IND) application paves the way for a phase 1 study evaluating the novel therapy in advanced liver cancer.
ACE723 is a glypican-3 (GPC3)-directed ADC developed using Acepodia’s proprietary Antibody-Dual-Drugs Conjugation (AD2C) technology. Unlike conventional ADCs that carry a single cytotoxic agent, ACE723 incorporates two distinct anti-cancer payloads intended to improve tumour cell killing and potentially overcome challenges associated with tumour heterogeneity and treatment resistance.
According to Acepodia leadership, the FDA decision represents a key advancement for the company’s ADC platform, marking the first AD2C-derived candidate to enter human clinical evaluation. The company plans to investigate the agent’s safety profile, pharmacokinetics and early signs of anti-tumour activity in patients with advanced HCC.
GPC3, the molecular target of ACE723, is commonly expressed on hepatocellular carcinoma cells and has emerged as a promising biomarker for targeted drug delivery. By binding to GPC3-positive tumours, the ADC is designed to selectively transport its therapeutic payloads to malignant cells while limiting exposure to healthy tissues.
Hepatocellular carcinoma is the most common form of liver cancer, representing over 70% of cases globally. Although recent advances in immunotherapy-based combinations have improved outcomes for some patients with advanced disease, treatment options remain limited once tumours progress or become resistant to existing therapies. This ongoing unmet need has driven interest in novel therapeutic approaches with differentiated mechanisms of action.
The upcoming phase 1 trial will assess safety, tolerability, dose-limiting toxicities and pharmacokinetic characteristics of ACE723. Researchers will also evaluate preliminary evidence of anti-cancer activity. The dose-escalation portion of the study is expected to identify an appropriate dose and schedule for future clinical development, including potential expansion cohorts.
As part of its broader international development strategy, Acepodia also submitted an IND application for ACE723 to China’s National Medical Products Administration (NMPA) in August 2026.
Acepodia is a clinical-stage biotechnology company focused on developing therapies for cancer and autoimmune disorders. Its platform technologies are built upon bio-orthogonal click chemistry innovations originating from the laboratory of Nobel Prize-winning scientist Carolyn Bertozzi, enabling the creation of targeted treatment modalities that combine antibodies with therapeutic payloads or immune cells.
