TianGang Yinuo's TGI-2 Receives NMPA Approval for Clinical Trials in Solid Tumors

HefeiApril 18, 2023PR Newswire -- April 18, 2023, Hefei TG ImmunoPharma Co., Ltd. (TGI), independently developed the anti-PVRIG monoclonal antibody injection (Project Code: TGI-2/NM1F) for the treatment of solid tumors. Its Investigational New Drug application (IND) has been approved by the National Medical Products Administration (NMPA) of China and will soon commence Phase I clinical research in China. This product received the FDA's tacit approval on December 17, 2022.

PVRIG, also known as CD112R, is an inhibitory receptor primarily expressed on the surface of NK cells and T cells. Tumor cells highly express PVRL2 on their surface, which binds to PVRIG on immune cells, transmitting inhibitory signals to the immune cells, weakening anti-cancer immunity, enabling immune escape, and promoting tumor progression.

TGI-2 is a recombinant humanized IgG1 monoclonal antibody that can bind to PVRIG with high affinity and specificity, effectively blocking the interaction between PVRIG and its ligand PVRL2, thereby promoting the anti-tumor effector functions of NK cells and T cells. Preclinical in vivo efficacy studies have shown that TGI-2 alone exhibits significant anti-cancer effects, and when combined with anti-PD-1 monoclonal antibodies, it further enhances anti-tumor immunity. Compared with existing competitors, TGI-2 demonstrates higher affinity and a lower effective dose, showing great potential for clinical application. The product's IND submission service and preclinical CMC services were provided by two strategic partners of TGI: Clinipace (formerly dMed-Clinipace) and GenScript ProBio.

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

"Tumor immunotherapy is an important strategic direction for TGI. We are committed to developing antibody drugs based on NK cells, hoping to bring new treatment options for cancer patients," said Professor Tian Zhigang, academician of the Chinese Academy of Engineering and the European Academy of Sciences, and founder of TGI. "We are very pleased that TGI-2 has been approved for clinical trials in China, and we will fully advance this Phase I clinical study. Meanwhile, the clinical trial of TGI-2 in the United States will soon welcome the first patient enrollment."