Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing of a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China.
Study Design and Objectives
The open, dose escalation, first-in-human Phase I study is designed to assess the safety and tolerability of the drug in advanced/metastatic solid tumors and lymphomas, with dose-limiting toxicity (DLT) and maximum tolerable dose (MTD) within 3 weeks after the first administration of HLX60 as the primary endpoints. Subjects will receive an intravenous infusion of different doses of HLX60 (once every three weeks: 0.5, 2, 5, 15, and 25 mg/kg).
HLX60: Mechanism and Development
HLX60 is an in-house developed glycoprotein A repetitions predominant (GARP)-targeted monoclonal antibody (mAb) being developed 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. A pre-clinical study showed that the combination of HLX60 and Henlius’s programmed death-1 (PD-1) inhibitor Hansizhuang (serplulimab) was superior to either one as a monotherapy in terms of anti-tumor effect. The said combo was approved for a Phase I clinical study in advanced/metastatic solid tumors in Australia in August this year. October saw the drug obtain approval for a Phase I study in solid tumors and lymphomas.-Fineline Info & Tech
