Shanghai, China, September 30, 2022 -Shanghai Henlius Biotech, Inc. (2696.HK) announced a phase 1 clinical trial of the company's HLX22, an anti-human epidermal growth factor receptor-2 (HER2) humanised monoclonal antibody(mAb) injection, has been completed in patients with HER2 overexpressing advanced solid tumours. The results of this study demonstrated the good safety and tolerability of HLX22.
This open-label, dose-escalation, phase 1 study aimed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of HLX22 in patients with HER2 overexpressing advanced solid tumours. Eligible patients were given different doses of HLX22 (3, 10, 25 mg/kg) intravenously every 3 weeks following 3+3 dose-escalation design. The primary endpoints of this study were the proportion of patients experiencing adverse events and the maximum tolerated dose (MTD) of HLX22. Secondary endpoints included pharmacokinetic parameters, immunogenicity, and preliminary efficacy. The results showed that HLX22 was safe and well tolerated. No dose-limiting toxicity (DLT) occurred during the study, and the MTD of HLX22 was 25 mg/kg.
HLX22 is an innovative anti-HER2 mAb introduced from AbClon, Inc. and further researched and developed by Henlius, potential indications including gastric cancer and breast cancer. HLX22 can also bind to HER2 subdomain at a different binding site from trastuzumab, which allows of simultaneous binding of HLX22 and trastuzumab to HER2. Up to now, Henlius has a well-established product pipeline in the area of anti-HER2 treatment. The company’s independently developed and manufactured trastuzumab biosimilar HANQUYOU, the first China-developed mAb biosimilar approved both in China and Europe, was approved in the EU, China, Australia, and many other countries and regions, providing a new standard treatment option for HER2 positive breast and gastric cancer patients worldwide. In addition, the first subject has been dosed in phase 3 clinical trial of the company’s pertuzumab biosimilar HLX11, a recombinant anti-HER2 subdomain II humanised mAb injection, for the neoadjuvant therapy in patients with HER2-positive, HR-negative early or locally advanced breast cancer, so as to further improving treatment outcomes for HER2 positive breast cancer patients. With the accumulated results and experience from extensive anti-HER2 research, the Company has also built a solid foundation for discovering and developing anti-HER2 Antibody X Molecule Conjugate. Recently, Henlius and Palleon have entered into a strategic collaboration to co-develop bifunctional HER2-sialidase, which will enhance Henlius' innovative pipeline.
Henlius will always place a high value on clinical data and will continue to diversify innovation by strengthening internal innovation capabilities and external collaboration, extending new drug forms, and processing more clinical trials to generate more effective treatments.