Acepodia has secured the US Food and Drug Administration (FDA) clearance of an investigational new drug (IND) application for ACE723, allowing it to begin a Phase I clinical trial in patients with unresectable or metastatic hepatocellular carcinoma (HCC).
ACE723 is an investigational antibody-drug conjugate (ADC) that targets glypican-3 (GPC3).
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It was created using Acepodia’s Antibody-Dual-Drugs Conjugation (AD2C) platform, which combines antibody engineering, medicinal chemistry and tumour biology.
GPC3 is a tumour-associated antigen often found in HCC, making it a possible route for delivering cytotoxic payloads to tumour cells.
Acepodia CEO and chairman Sonny Hsiao said: “The FDA clearance of ACE723 marks an important milestone for our AD2C platform and brings our first AD2C-generated candidate into clinical development.
“ACE723 is designed to deliver two cytotoxic payloads to GPC3-expressing tumour cells, with the goal of addressing tumour heterogeneity and potential resistance to single-payload therapies.
“We look forward to evaluating its safety, pharmacokinetics and preliminary anti-tumour activity in patients with unresectable or metastatic HCC.”
The planned trial will also assess the tolerability and dose-limiting toxicities.
Acepodia expects the dose-escalation stage to characterise the safety profile and identify a recommended dose for later study, including possible expansion cohorts.
The company is also pursuing approval to study the candidate elsewhere.
It filed an IND application for ACE723 with China’s National Medical Products Administration (NMPA) last month, as part of a global development plan for the programme.
According to Acepodia, immunotherapy-based combinations have improved first-line care for patients with unresectable or metastatic disease, but needs remain unmet for those whose disease progresses or stops responding to treatment.
The company develops therapies for cancer and autoimmune diseases using conjugation technology platforms.
Alongside AD2C, the company runs an Antibody-Cell Conjugation (ACC) platform, which combines antibodies with immune cells or therapeutic payloads.
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