Yusebio-KY antibody drug wins FDA clearance to enter human trials

Yusebio-KY has received U.S. clearance to take ACE723 into human testing, opening the way for the Taiwanese drug developer’s first clinical-stage development of the treatment.

The company said ACE723 is an antibody-drug conjugate designed to target GPC3, a tumor-associated antigen frequently expressed in hepatocellular carcinoma. It uses Yusebio-KY’s proprietary antibody dual-drug conjugation platform, known as AD2C, to deliver two chemotherapy payloads selectively to tumor cells.

Yusebio-KY Chairman and Chief Executive Hsiao Shih-chia said the approach could help address tumor heterogeneity and resistance that may arise when treatment relies on a single chemotherapy drug. “ACE723 uses an antibody-specific delivery mechanism to deliver two chemotherapy drugs to tumor cells expressing the GPC3 antigen,” he said. The company hopes the treatment will show good tolerability and potential to meet an unmet medical need in liver cancer trials.

The planned Phase 1 study will enroll patients with unresectable or metastatic hepatocellular carcinoma. Researchers will evaluate safety, tolerability, dose-limiting toxicity, pharmacokinetics and preliminary antitumor activity. A dose-escalation phase will further define the treatment’s safety profile and establish a recommended dose for later development and possible expansion stages.

Yusebio-KY said hepatocellular carcinoma accounts for more than 70% of liver cancer cases and has a five-year survival rate of about 22%. For patients with advanced disease that cannot be surgically removed or has spread, first-line treatment currently relies mainly on combination immunotherapy.

“

ACE723 uses an antibody-specific delivery mechanism to deliver two chemotherapy drugs to tumor cells expressing the GPC3 antigen, with the hope of overcoming tumor heterogeneity and the drug resistance that may arise with a single chemotherapy drug.