Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal antibody (TAB009/JS009) for the treatment of advanced solid tumors.

Junshi Biosciences explained in its press release that the TAB009/JS009 is a recombinant humanized IgG4 monoclonal antibody against human CD112R developed independently by Junshi Biosciences, for the treatment of advanced malignant tumors. CD112R, also known as PVRIG (Poliovirus receptor-related immunoglobulin domain-containing protein), is a new immune checkpoint pathway discovered by the company. Dr. Sheng Yao, Senior Vice President of the company, is one of the discoverers of this novel pathway.

CD112R is a single-pass transmembrane protein of the PVR family, mainly 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 can inhibit the anti-tumor effect of T cells and NK cells after ligand engagement. TAB009/JS009 binds specifically to CD112R with high affinity and effectively blocks the interaction between CD112R and its ligand CD112, thereby facilitating the activation and proliferation of T cells and NK cells and enhancing the immune system’s ability to kill tumor cells. To date, no product targeting CD112R has been approved for marketing globally, the company noted.

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. TAB009/JS009 can work synergistically with TIGIT blocking antibodies to promote T cell activation. Pre-clinical in vivo pharmacodynamics has shown that TAB009/JS009 in combination with the anti-TIGIT monoclonal antibody (TAB006/JS006) developed independently by the company exhibits significant synergistic anti-tumor effects. The investigational new drug application for TAB006/JS006 has already been approved by both China’s National Medical Products Administration (NMPA) and the U.S. FDA, the company said.

In addition, 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. Junshi Biosciences said that it plans to actively explore drug combinations to maximize the synergistic anti-tumor potential of its self-developed products.