Appclon "First Patient Dosed in Multinational Phase 3 Trial for HER2-Positive Gastric Cancer"

Appclon announced on the 26th that ‘AC101 (Henryus codename HLX22)’ has completed the first patient dosing in the multinational Phase 3 clinical trial (HLX22-GC-301). The HLX22-GC-301 clinical trial, which evaluates the combination therapy of trastuzumab and chemotherapy, has received Phase 3 clinical approval in China, the United States, and Japan.

HLX22 is a global first-line treatment for HER2 (human epidermal growth factor receptor 2)-positive advanced gastric cancer and gastroesophageal junction cancer, based on AC101, which was licensed to Henryus Biotech (hereinafter Henryus) in 2016. To date, dual HER2 blockade therapy for HER2-positive gastric cancer has never received global commercialization approval.

A company representative stated, "HER2-positive gastric cancer and gastroesophageal junction cancer have emerged as major health issues worldwide, with approximately one million new cases reported globally," adding, "This disease is often diagnosed late, resulting in poor prognosis, with a 5-year survival rate of only 6%."

HER2-positive patients show worse prognosis compared to HER2-negative patients. Currently, the combination therapy of trastuzumab and chemotherapy is used as the standard treatment, but there is a need for improvement in treatment outcomes and prognosis.

HLX22 is an antibody that can bind to the HER2 protein simultaneously with trastuzumab, promoting HER2 internalization and degradation, thereby enhancing anti-tumor activity. Preclinical and Phase 1 trial results demonstrated that the combination of HLX22 and trastuzumab induces tumor suppression and cell apoptosis through a synergistic effect while ensuring safety. The ongoing clinical trial uses progression-free survival (PFS) and overall survival (OS) as the primary endpoints compared to existing therapies.

Meanwhile, Appclon received the ‘Global Excellent Partner Award’ in recognition of its partnership as a global outstanding partner at the 30th anniversary ceremony of China’s Fosun Pharma Group held in Shanghai on the 17th.