AbClon announced on the 18th of April that the first patient in China has been dosed in a Phase 2 clinical trial evaluating 'AC101' in combination with Enhertu for the treatment of HER2-low, hormone receptor (HR)-positive, locally advanced or metastatic breast cancer.

The company stated that this trial shall expand the treatment scope of AC101 to the entire breast cancer area from the currently proved HER2-positive gastric cancer field, and provide new treatment options for a broader group of cancer patients.

According to GLOBOCAN, a cancer data research platform, breast cancer is the second most frequently diagnosed cancer worldwide, with approximate 2.3 million new cases diagnosed in 2022. HER2-low breast cancer accounts for 45-55% of all breast cancer cases, but currently lacks targeted therapies, relying mainly on endocrine therapy or chemotherapy. Although Enhertu has recently been approved, there is still a high demand for safe and effective treatments.

The Phase 3 clinical trial (AC101-GC-301) of AC101 in combination with trastuzumab and chemotherapy for gastric cancer patients has been approved in major countries including China, the United States, Japan, and Australia. The first patient has been dosed along with IND approvals in major countries, and the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the treatment of gastric cancer last month.

Based on the significant results in HER2-positive gastric cancer, AC101 is expanding its treatment area to various HER2-expressing solid tumors. Last year, Phase 2 clinical trials of AC101 in combination with trastuzumab and chemotherapy, or in combination with Enhertu, were approved in China and are currently underway.

An AbClon official said, "We expect Henlius continue to attempt to expand the treatment and market for anti-HER2 targeted therapies, and accelerate the global development of AC101. We will strive to provide more effective and economical treatment options."

Meanwhile, at the Henlius 2025 R&D Conference held in Shanghai on the 15th, CEO Jason Zhu cited AC101 as one of the key assets in Henlius for the future, expressing confidence in its success. Professor Lin Shen, who is conducting the clinical trials, predicted that AC101 will show great therapeutic effects in patients worldwide with various solid tumors, including HER2-positive gastric cancer and breast cancer.