Recently, Henlius announced that the results of the phase 1 clinical trial of HLX22, an innovative anti-HER2 humanised monoclonal antibody (mAb) injection, were published in Investigational New Drugs. The results of this study demonstrated the safety and tolerability of HLX22, and laid the foundation to explore more therapies such as HLX22 combined with trastuzumab.
HLX22 is an innovative anti-HER2 mAb that was introduced from AbClon, Inc. and further researched and developed by Henlius. This first-in-human, phase 1 dose-escalation study aimed to evaluate the safety, tolerance, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HLX22 in patients with HER2 overexpressing advanced solid tumours who had failed or were intolerant to standard therapies. The primary endpoints were safety and the maximum tolerated dose (MTD). Secondary endpoints included pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy. 11 patients were enrolled to receive HLX22 once every 3 weeks at 3 (n = 5), 10 (n = 3), and 25 (n = 3) mg/kg doses. No serious adverse events or dose-limiting toxicities occurred during the treatment period, and the MTD was determined at 25 mg/kg once every 3 weeks. The disease control rate and median progression-free survival were 36.4% (95% confidence interval [CI], 7.9–64.8) and 44.0 days (95% CI, 41.0–170.0), respectively.
HLX22 can also bind to HER2 subdomain IV at a different binding site from trastuzumab, which allows the simultaneous binding of HLX22 and trastuzumab to HER2. Pre-clinical studies showed that the combination therapy of HLX22 and trastuzumab would inhibit the cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1) and enhance the antitumor activity in vitro and in vivo. The above phase I study showed that HLX22 was well tolerated in patients with advanced solid tumours overexpressing HER2 after failure of standard therapies, further supporting the investigation of HLX22 in combination of trastuzumab and chemotherapy. At present, the phase 2 clinical trial of HLX22 in combination with HANSIZHUANG (serplulimab) and HANQUYOU (trastuzumab, trade name in Europe: Zercepac®, trade names in Australia: Tuzucip® and Trastucip®) and chemotherapy as the first-line treatment for HER2-positive locally advanced/metastatic gastric cancer (GC) has been conducted.
Up to now, Henlius has a well-established product pipeline in the area of anti-HER2 treatment including HANQUYOU, HLX22 and HLX11 (pertuzumab biosimilar). With regards to antibody technology, the company has built a solid foundation for discovering and developing bispecific/innovative antibodies to develop more biologics to provide patients with more effective therapies.
About Investigational New Drugs
The development of new anticancer agents is one of the most rapidly changing aspects of cancer research. Investigational New Drugs (Impact Factor：3.651) provides a forum for the rapid dissemination of information on new anticancer agents. The papers published are of interest to the medical chemist, toxicologist, pharmacist, pharmacologist, biostatistician and clinical oncologist. Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of scientists developing anticancer agents.
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