Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a global multi-center Phase III clinical study. The study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of HER2+ advanced gastric cancer. Currently, no HER2 dual-targeted therapy is available globally for the treatment of HER2+ gastric cancer.
HLX22 is a humanized IgG1 monoclonal antibody (mAb) that targets human epidermal growth factor receptor 2 (HER2). Henlius obtained the rights to HLX22 through an agreement with South Korea-based AbClon Inc., which was signed in October 2016. Both HLX22 and trastuzumab are anti-HER2 antibodies that bind to domain IV of the HER2 receptor, albeit at different epitopes. This distinct binding capability enables the simultaneous targeting of HER2 domain IV by both antibodies, leading to an enhanced blocking effect on the HER2 receptor. Pre-clinical studies have indicated that the combination of HLX22 and trastuzumab has synergistic effects and is superior to either drug when used as monotherapy in inhibiting tumor growth. Phase I data have demonstrated that HLX22 is safe and well-tolerated in patients with advanced solid tumors that overexpress HER2. Positive results from a Phase II study evaluating the combination of HLX22 with trastuzumab in HER2+ gastric cancer were reported in January this year.- Flcube.com
