Appclon "AC101 Combination Clinical Trial Holds First In-Person Researcher Meeting in Japan... Accelerating Clinical Research"

Appclon announced on the 6th that it has successfully concluded an in-person investigator meeting for the clinical study of the AC101 (code name HLX22) combination therapy, which was licensed to Henlius, in Japan.

At this meeting, discussions were held regarding the international Phase 3 clinical trial (HLX22-GC-301) evaluating HLX22, trastuzumab, and chemotherapy combination therapy as a first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. More than 50 oncologists and researchers from over 20 clinical institutions in Japan participated. The clinical advantages of HLX22 and the development strategy within Japan were intensively discussed.

Dr. Ken Kato of the National Cancer Center Japan stated, "This meeting was very productive, and we expect meaningful progress through collaboration among researchers," and Dr. Hiroshi Imamura of Toyonaka Municipal Hospital said, "Through in-depth discussions on the clinical trial, we have enhanced our understanding of the study and will actively promote patient enrollment at our institution."

Japan has one of the highest incidence and mortality rates of gastric cancer worldwide, with HER2-positive patients accounting for approximately 12?23% of all gastric cancer cases. The current standard first-line treatment for HER2-positive locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) cancer is trastuzumab combined with chemotherapy. For PD-L1 positive (PD-L1 CPS ≥1) patients, the addition of immunotherapy is also recommended; however, long-term treatment efficacy and prognosis improvement remain unmet needs. Dual HER2-targeted therapies for HER2-positive gastric cancer have not yet been approved in the global market.

HLX22 is an innovative anti-HER2 monoclonal antibody (mAb) that binds to domain IV of the HER2 extracellular domain. It binds to a different epitope than trastuzumab and promotes HER2 internalization and degradation. Clinical data indicate 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 evaluating 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. Through this meeting, patient characteristics, diagnostic and treatment standards, and clinical trial protocols in Japan were discussed in depth, which is expected to facilitate efficient study progress.

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

They continued, "We will continue to develop innovative anticancer therapies through ongoing research and collaboration and play an important role in the global healthcare market."