[by Lee, Young Sung] AbClon announced on March 27 the successful administration of its anticancer candidate, 'AC101,' to the first patient in Japan. This marks the initial step in the ongoing global Phase 3 clinical trial (HLX22-GC-301), which evaluates the combination of AC101 with 'trastuzumab' and 'chemotherapy'.
AC101 is an investigational drug candidate for which AbClon has transferred technology to Henlius. It is being developed under the code name HLX22 as a 안전한 바카라 사이트-line treatment for HER2-positive advanced gastric cancer and gastroesophageal junction (G∙GEJ) cancer.
The clinical trial is led by Principal Investigator Professor Lin Shen of Peking University Cancer Hospital. The 안전한 바카라 사이트 patient administration was successfully conducted in China, and a global Phase 3 clinical trial is currently in progress in the United States.
In Japan, 안전한 바카라 사이트 administration proceeded promptly following a recent researcher meeting, reflecting strong interest and active engagement in the clinical trial, according to the company. To date, no dual HER2-blocking therapy for HER2-positive gastric cancer has received regulatory approval worldwide.
Gastric cancer and gastroesophageal junction cancer continue to pose significant global health challenges. In 2022, approximately one million new cases were reported worldwide. In 안전한 바카라 사이트, gastric cancer ranked third among all cancers in both incidence and mortality, with approximately 127,000 newly diagnosed cases and 44,000 related deaths recorded that year.
Gastric cancer and gastroesophageal junction cancer are frequently diagnosed at advanced stages, resulting in poor prognosis, with a five-year relative survival rate of only 6%. Among patients with gastric cancer, HER2 positivity is observed in approximately 12-23% of cases and is associated with a worse prognosis compared to HER2-negative cases. Currently, the standard 안전한 바카라 사이트-line treatment for locally advanced or metastatic HER2 positive gastric cancer consists of a combination of trastuzumab and chemotherapy, with the addition of immunotherapy recommended based on PD-L1 expression (CPS (Critical Success Factor Score) 1). However, despite these treatment options, significant limitations remain in improving therapeutic efficacy and prognosis.
HLX22 is an innovative anti-HER2 monoclonal antibody developed by Apclone. It binds to the HER2 extracellular domain IV, a distinct site from the trastuzumab, and exerts its therapeutic effect by simultaneously inhibiting HER2 homodimerization and HER2-EGFR heterodimerization. This mechanism facilitates HER2 receptor internalization and dimer degradation, thereby enhancing the anticancer efficacy.
In Phase 2 clinical trials, HLX22 was administered as a 안전한 바카라 사이트-line treatment to patients with HER2-positive locally advanced or metastatic gastric cancer in combination with HLX02 (a trastuzumab biosimilar) and XELOX. The study demonstrated an improved treatment effect while confirming that the safety profile remained manageable. The findings were officially presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) this year.
The Phase 3 clinical trials are designed as double-blind, randomized, and controlled multi-center studies. The primary objective is to evaluate and compare the efficacy and safety of HLX22 + trastuzumab + chemotherapy versus trastuzumab + chemotherapy (±pembrolizumab) in 안전한 바카라 사이트s with HER2-positive locally advanced or metastatic gastric and gastroesophageal junction cancer.
Participants in the study will be randomly assigned in a 1:1 ratio to either the experimental group, receiving HLX22 (15 mg/kg IV) in combination with trastuzumab and chemotherapy, or the control group, receiving a placebo with trastuzumab and chemotherapy (±pembrolizumab). The primary endpoints of the trial include progression-free survival (PFS) and overall survival (OS), assessed by the Institutional Research Review Committee (IRRC) based on the latest version of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), quality of life, safety, immunogenicity, and pharmacokinetics.
“Along with the rapid advancement of this clinical trial, Henlius’ stock price is also rising, reflecting growing expectations for the recent HLX22 clinical trial results,” an 안전한 바카라 사이트 official stated. “The industry is increasingly focused on whether HLX22 can address the limitations of existing HER2 treatments and establish itself as a new treatment option.”
“Based on the results of this 안전한 바카라 사이트 3 clinical trial, the potential for future commercialization is also garnering significant attention,” the official further added.