China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its subsidiary, Shanghai Henlius Biotech (HKG: 2696), has completed a clinical trial filing for HLX301 in Australia. Henlius will conduct a Phase I clinical study in the country for the bispecific antibody (BsAb) targeting programmed-death-ligand 1 (PD-L1) and T cell immunoglobulin and ITIM domains (TIGIT) in locally advanced or metastatic solid tumors.
TIGIT Mechanism and Preclinical Trials
TIGIT is considered another immune checkpoint, found on NK cells and T cells. It binds to the highly expressed PVR receptors on tumor cells, mediating the inhibitory signal of the immune response. This binding directly inhibits the killing effect of NK cells and T cells, contributing to tumor cell immune evasion. Previous preclinical trials have shown that combining anti-TIGIT antibodies with anti-PD-1/PD-L1 antibodies can work synergistically, enhancing anti-tumor effects and improving outcomes compared to PD-1 therapy alone.
Market Landscape
Most TIGIT products currently in development are monoclonal antibodies (mAb), such as Roche’s tiragolumab, BeiGene’s BGB-A1217, Bristol Myers Squibb’s BMS-986207, OncoMed Pharmaceuticals’ OMP-313M32, Junshi Bio’s JS006, Huahai Pharma’s HB0030, Bio-Thera Solutions’ BAT6021, and Innovent Bio’s IBI939. Merck Sharp & Dohme is developing MK-7684A, a fixed-dose combination of anti-TIGIT and anti-PD-1/PD-L1 antibodies. Innovent/Lilly also have IBI321 under development. Currently, there is no PD-L1/TIGIT BsAb on the market globally.-Fineline Info & Tech
