Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will evaluate the combination of HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, with Henlius’s programmed-death 1 (PD-1) inhibitor HaiSiZhuang (serplulimab) and chemotherapy for first-line advanced non-small cell lung cancer (NSCLC).
LAG-3: A Novel Approach to T Cell Activation and Tumor Immunity
LAG-3 is a complex-binding immunoassay receptor that stimulates effector T cell activity while inhibiting T reg activity, offering a mechanism of action similar to that of programmed death-1 (PD-1) inhibition. This inhibitor is predominantly expressed on activated T cells and some NK cells, exerting a negative regulatory effect on T cell proliferation, activation, and homeostasis. By inhibiting LAG-3, the immune system’s T cells can be reactivated, enhancing their ability to target and destroy tumor cells.
HaiSiZhuang: A PD-1 Inhibitor with Broad Clinical Applications
Serplulimab, known as HaiSiZhuang, was approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have not responded to standard therapy. The drug is currently under investigation in multiple clinical studies globally, including as part of eleven different combination therapies. Additionally, a market filing for serplulimab combined with cisplatin plus fluorouracil (5-FU) for first-line locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) has been accepted for review by the NMPA.-Fineline Info & Tech
