Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. This marks a significant step forward in the development of innovative treatments for these challenging cancers.
HLX60: Mechanism and Development
HLX60 is an in-house developed glycoprotein A repetitions predominant (GARP)-targeted monoclonal antibody (mAb) designed to treat solid tumors and lymphomas. GARP is highly expressed on the surface of activated regulatory T cells (Treg), platelets, and some tumor cells. HLX60 can bind to GARP and specifically block the release of TGF-β1 mediated by GARP, thereby releasing the immunosuppression formed by TGF-β1 and improving the anti-tumor immune response. Pre-clinical studies have shown that the combination of HLX60 and Henlius’s programmed death-1 (PD-1) inhibitor HaiSiZhuang (serplulimab) was superior to either one as a monotherapy in terms of anti-tumor effect.
Clinical Study Approval
The combination of HLX60 and HaiSiZhuang (serplulimab) was approved for a Phase I clinical study in advanced/metastatic solid tumors in Australia in August this year. The approval from the NMPA now allows Henlius to expand its clinical studies to mainland China, further evaluating the safety and efficacy of HLX60 in treating solid tumors and lymphomas.
Future Outlook
The approval for the Phase I clinical study of HLX60 underscores Henlius Biotech’s commitment to advancing innovative cancer therapies. By targeting GARP, HLX60 aims to enhance the anti-tumor immune response and address significant unmet medical needs in oncology.-Fineline Info & Tech
