Appclon: "Partner Henlius Expands AC101 Clinical Trials to Three"

First Patient Dosed in Phase 2/3 Trial for First-Line Treatment of HER2-Positive Breast Cancer
Accelerating Parallel Development for HER2-Low Breast Cancer and Phase 3 Gastric Cancer Trials

Appclon announced on March 3 that its partner company, Henlius, has expanded the number of clinical trials for the HER2-targeting antibody AC101 (HLX22) to three.

Appclon company logo image. Appclon

According to Appclon, Henlius recently initiated the first patient dosing in a Phase 2/3 clinical trial combining AC101 with its own HER2 ADC, HLX87, targeting first-line treatment for HER2-positive breast cancer. The company has thus expanded its development strategy, which was previously focused on gastric cancer, into the area of first-line breast cancer treatment.

A Phase 2 clinical trial is also underway targeting patients with HER2-low, HR-positive, locally advanced or metastatic breast cancer. This trial involves combining AC101 with standard therapy or T-DXd. The clinical trial began last year, and patient enrollment has been completed in China.

In addition, a global Phase 3 trial (HLX22-GC-301) of AC101 for first-line treatment of gastric cancer is ongoing in the United States, China, Japan, Korea, Australia, and South America. At the JPM Conference in January this year, Henlius reported that the dosing rate had surpassed 40%.

This content was produced with the assistance of AI translation services.