Junshi Biosciences' Anti-CD112R Monoclonal Antibody, TAB009/JS009, Receives FDA IND Approval for Advanced Solid Tumors
核心洞察
Junshi Biosciences received FDA approval for its Investigational New Drug (IND) application for TAB009/JS009 (搜索), an anti-CD112R (搜索) monoclonal antibody, targeting advanced solid tumors (搜索).
TAB009/JS009 (搜索) is designed to block the interaction between CD112R (搜索) and CD112, enhancing the immune system's ability to kill tumor cells by activating T cells and NK cells.
Pre-clinical studies suggest TAB009/JS009 (搜索) may synergize with TIGIT blocking antibodies and anti-PD-1 antibodies like toripalimab to further enhance T-cell activation and improve clinical efficacy.
Shanghai Junshi Biosciences Co., Ltd announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for TAB009/JS009 (搜索), an anti-CD112R (搜索) monoclonal antibody, for the treatment of advanced solid tumors (搜索). This approval marks a significant step in Junshi Biosciences' efforts to develop innovative therapies for cancer.
Mechanism of Action
TAB009/JS009 (搜索) is a recombinant humanized IgG4 monoclonal antibody that targets human CD112R (搜索), also known as PVRIG (Poliovirus receptor-related immunoglobulin domain-containing protein). CD112R is an immune checkpoint pathway. CD112R is expressed on T cells and NK cells, and is significantly upregulated upon activation. CD112R and TIGIT share a common ligand, CD112, which is expressed on the surface of antigen-presenting cells and certain tumor cells. CD112R inhibits the anti-tumor effect of T cells and NK cells after ligand engagement. TAB009/JS009 binds specifically to CD112R with high affinity, blocking the interaction between CD112R and its ligand CD112. This blockade facilitates the activation and proliferation of T cells and NK cells, enhancing the immune system’s ability to target and kill tumor cells. To date, no product targeting CD112R has been approved for marketing globally.
Synergistic Potential with Other Immunotherapies
Junshi Biosciences is exploring the potential of TAB009/JS009 (搜索) in combination with other immunotherapies. TIGIT is another immunosuppressive target of the PVR family. Its ligands include PVR and CD112, and its binding site for CD112 is different from that of CD112R (搜索). Pre-clinical in vivo pharmacodynamics studies have indicated that TAB009/JS009, when combined with the anti-TIGIT monoclonal antibody (TAB006/JS006) developed by Junshi Biosciences, exhibits significant synergistic anti-tumor effects. The IND application for TAB006/JS006 has already been approved by both China’s National Medical Products Administration (NMPA) and the U.S. FDA. Furthermore, combining TAB009/JS009 with TAB006/JS006, as well as Junshi Biosciences’ commercialized anti-PD-1 monoclonal antibody, toripalimab, can further increase T-cell activation and improve the efficacy of clinical treatment. Junshi Biosciences plans to actively explore drug combinations to maximize the synergistic anti-tumor potential of its self-developed products.