TianGang Yinuo's Novel Anti-Cancer Monoclonal Antibody TGI-5 Receives FDA IND Clearance

HefeiNovember 30, 2023/PR Newswire/ --On November 30, 2023, the monoclonal antibody drug (project code TGI-5) independently developed by Hefei TG ImmunoPharma Co., Ltd. (TGI) received clinical trial (IND) approval from the U.S. Food and Drug Administration (FDA). Currently, no products targeting the same point have been approved for marketing in or outside of China.

TGI-5 is a novel immunological checkpoint monoclonal antibody drug independently developed by TGI. As an antibody drug targeting a completely new drug target, TGI-5 exhibits high anti-tumor activity and excellent druggability, and is mainly used for the treatment of indications such as liver cancer, colorectal cancer, and lung cancer.

TGI-5, after binding to its target, can simultaneously restore the anti-cancer immune functions of NK cells and T cells. Preclinical studies have shown that this antibody exhibits potent anti-tumor activity in animal models of liver cancer, colorectal cancer, and melanoma, surpassing that of PD-1 antibodies. Additionally, TGI-5 has a synergistic anti-cancer effect with PD-1 therapy. The product was provided with IND filing and submission services by two strategic partners of TGI, Caidya (formerly dMed-Clinipace), and preclinical CMC services by GenScript ProBio.

According to Professor Tian Zhigang, academician of both the Chinese Academy of Engineering and the European Academy of Sciences, and founder of TGI, "I am genuinely delighted and proud that the TGI-5 project has been granted clinical trial approval. Currently, the only global competing drug targeting the same site is undergoing Phase I clinical trials. Compared with the competing product, TGI-5 binds to different antigen epitopes and exhibits stronger biological activity. Meanwhile, there is still much for us to explore. The TGI team has already started more in-depth research on the next-stage projects. TGI adheres to an independent innovation route in the NK cell field, where we have over 10 product pipelines progressing as planned, hoping to bring more novel therapies to patients worldwide."