Henlius’ OX40 Monoclonal Antibody HLX51 Gains NMPA Approval for Phase I Clinical Study

Shanghai Henlius Biotech, Inc (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in mainland China for its OX40 monoclonal antibody (mAb), HLX51. The study will focus on patients with advanced/metastatic solid tumors and lymphoma.

Mechanism of Action
OX40, also known as TNFRSF4 CD134, is a costimulatory molecule primarily expressed on activated T cells. The interaction between OX40 and its ligand, OX40L, releases costimulatory signals, inhibits activation-induced cell death (AICD), and promotes the survival of antigen-specific memory T cells. HLX51 competes with OX40L to bind with OX40, stimulating T cell proliferation and activation without reducing the OX40 signal. This enhances T cell killing ability and also inhibits the proliferation and activation of regulatory T cells (Treg), thereby improving the immunosuppressive effect in the tumor microenvironment and promoting cytokine release from T cells.

Pre-Clinical Findings
Pre-clinical studies have shown that HLX51 can significantly inhibit tumor growth and has demonstrated good tolerability and a safety profile. These findings support the potential of HLX51 as a promising treatment option for advanced tumors and lymphoma.-Fineline Info & Tech

Fineline Info & Tech