The US Food and Drug Administration (FDA) has approved the investigational new drug (IND) application for Shanghai Junshi Biosciences’ anti-CD112R monoclonal antibody (TAB009/JS009) to treat advanced solid tumours.
A recombinant humanized IgG4 monoclonal antibody, TAB009/JS009 is developed against human CD112R to treat advanced malignant tumours.
CD112R, also known as Poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG), is PVR family’s single-pass transmembrane protein, which is mainly expressed on NK cells and T cells.
The monoclonal antibody binds specifically to PVRIG and blocks the CD112R and its ligand CD112 interaction effectively.
This enables the activation and proliferation of T cells and NK cells that will enhance the ability of immune system to kill tumour cells.
Junshi Biosciences stated that the TAB009/JS009 and the anti-TIGIT monoclonal antibody (TAB006/JS006) combination showed significant synergistic anti-tumour effects in the pre-clinical in vivo pharmacodynamics.
The TAB006/JS006’s IND has already been approved by China’s National Medical Products Administration (NMPA).
The company said: “TAB009/JS009 in combination with TAB006/JS006 as well as the company’s commercialized product toripalimab, the anti-PD-1 monoclonal antibody, can further increase T-cell activation and improve the efficacy of clinical treatment.”
Furthermore, the company is planning to explore the drug combinations for maximising the potential of its products.
In November last year, China’s National Medical Products Administration (NMPA) approved the supplemental New Drug Application (sNDA) for Junshi’s toripalimab in combination with cisplatin and gemcitabine.
The combination therapy is intended to treat locally recurrent or metastatic nasopharyngeal carcinoma (NPC) patients.
The sNDA was based on the double-blind, randomised, placebo-controlled, international multi-centre Phase III JUPITER-02 clinical study.