Tiangang Yinuo's TGI-2 Receives FDA Clearance for Phase I Clinical Trial in Solid Tumors

HefeiDecember 17, 2022PR Newswire -- On December 17, 2022, the clinical trial application for the anti-PVRIG monoclonal antibody injection (project code TGI-2/NM1F), independently developed by Hefei TG ImmunoPharma Co., Ltd. (TGI), received the FDA's tacit approval for the treatment of solid tumors and will soon commence Phase I clinical research in the United States. Currently, there are no PVRIG-targeting products approved for marketing in China or globally.

PVRIG, also known as CD112R, is an immunosuppressive receptor primarily expressed on the surface of NK cells and T cells. In the immunosuppressive microenvironment of tumor tissues, anti-cancer effector cells (such as NK cells and T cells) are "forced" to overexpress PVRIG, leading to functional suppression and loss of anti-cancer capabilities. In short, tumor cells highly expressPVRL2Binding to PVRIG on immune cells, thereby transmitting inhibitory signals to immune cells, weakening anti-cancer immunity, achieving immune escape, and promoting tumor development.

NK Cells Are Key Cytotoxic Cells That, Together With T Cells, Form the Core Defense of Anti-Tumor Immunity. Professor Zhigang Tian, Founder of TGI and Academician of the Chinese Academy of Engineering, Has Focused on NK Cell Basic and Translational Research for Over 30 Years. He Discovered That Targeting PVRIG Can Significantly Restore the Anti-Cancer Function of NK Cells While Simultaneously Activating the Anti-Tumor Effects of T Cells.

TGI-2/NM1F is a recombinant humanized IgG1 monoclonal antibody targeting PVRIG, used for the treatment of solid tumors. This antibody binds to PVRIG with high affinity, blocking PVRIG/PVRL2Interaction, restoring the anti-tumor immune function of NK cells and T cells. Preclinical studies show that this antibody has a longer half-life and high tolerable dose. Meanwhile, in vivo efficacy experiments demonstrate that this antibody alone exhibits significant anti-cancer effects, and when combined with anti-PD-1 monoclonal antibody, it can further enhance anti-cancer immunity.

According to Professor Zhigang Tian, academician of the Chinese Academy of Engineering and the European Academy of Sciences, and founder of TGI, "TGI-2 has demonstrated significant anti-cancer efficacy and favorable safety. Compared with competing products, this antibody exhibits higher affinity and a lower effective dose, showing great clinical potential. We will conduct rigorous and prudent clinical research on TGI-2. We are very pleased that TGI-2 has been quickly approved for clinical trials in the United States, and we will fully advance this Phase I clinical study. Meanwhile,Clinical trials in China will also submit applications soon.。”