AbClon announced on the 6th that Henlius successfully held a face-to-face investigator meeting for clinical research in Japan on the AC101 (code name HLX22) combination therapy, which was licensed out to Henlius.  

The meeting focused on discussions regarding the global Phase 3 clinical trial (HLX22-GC-301) to evaluate the combination therapy consisting of HLX22, trastuzumab, and chemotherapy as a first-line treatment for HER2-positive advanced gastric cancer. Over 50 oncologists and researchers from more than 20 clinical institutions in Japan attended the meeting and intensively discussing the clinical advantages of HLX22 and its development strategy in Japan.  

Dr. Ken Kato of the National Cancer Center Japan stated, "This meeting was very productive, and we expect meaningful progress through collaboration among researchers." Dr. Hiroshi Imamura of Toyonaka Municipal Hospital said, "Through in-depth discussions on the clinical trial, we have increased the understanding of the research and will try to enroll the patients at our institution."  

Japan belongs to countries with the highest rates of gastric cancer incidence and mortality. HER2-positive patients account for approximately 12-23% of all gastric cancer patients. Currently, the standard first-line treatment for HER2-positive locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) cancer is trastuzumab combined with chemotherapy. While the addition of immunotherapy is recommended for PD-L1-positive (PD-L1 CPS ≥1) patients, there remains a need for improved long-term treatment efficacy and prognosis. In the global market, dual HER2-targeted therapies for HER2-positive gastric cancer have not yet been approved.

HLX22 is an innovative anti-HER2 monoclonal antibody (mAb) that binds to the HER2 extracellular domain IV, with a mechanism that promotes HER2 internalization and degradation by binding to a different site than trastuzumab. Clinical data have shown that adding HLX22 significantly improves survival and antitumor effects in HER2-positive gastric cancer patients, with a manageable safety profile.  

The HLX22-GC-301 study is a multinational Phase 3 clinical trial to evaluate the efficacy and safety of HLX22, trastuzumab, and chemotherapy combination therapy as a first-line treatment for HER2-positive metastatic gastric/gastroesophageal junction cancer patients. Japan is one of the key countries in this study. The meeting provided an in-depth discussion of patient characteristics, diagnostic and treatment criteria, and clinical trial protocols in Japan, which is expected to facilitate efficient study progress.  

An AbClon representative stated, "Our goal is to provide better treatment options to patients worldwide through the development of innovative antibody therapeutics. We hope that the successful progress of the HLX22 clinical trial will bring new hope to HER2-positive gastric cancer patients."

They further emphasized, "We will continue to develop innovative anticancer therapeutics through ongoing research and collaboration, and play a significant role in the global healthcare market."