TianGang Immunotherapeutics Announces Phase I Clinical Trial Approval for Novel Immune Checkpoint Monoclonal Antibody TGI-5 with Potential Across Multiple Cancers

　　【Pharmaceutical Network Enterprise NewsRecently, the monoclonal antibody drug (project code TGI-5) independently developed by a Hefei company has been approved by the China National Medical Products Administration (NMPA) and will soon enter Phase I clinical trials in China.
 

It is reported that on March 22, Hefei TG ImmunoPharma Co., Ltd. (TGI) independently developed a monoclonal antibody drug (Project Code: TGI-5), which has been approved to commence Phase I clinical research. The product obtained the FDA's Investigational New Drug (IND) approval in the United States on November 30, 2023. Currently, no products targeting the same point have been approved for marketing in or outside of China.
 

Data shows that TGI is a biotechnology company founded by a research and development team led by Professor Tian Zhigang, an academician of both the Chinese Academy of Engineering and the European Academy of Sciences. The company is committed to the development of innovative immune drugs targeting specific sites. TGI currently has a professional R&D base covering nearly 8,000 square meters, including SPF-level animal laboratories, GMP-standard recombinant protein laboratories, BSL-2 biosafety laboratories, and NK cell detection and analysis platforms. It has a pipeline of more than 10 products, with over half having completed preclinical studies.
 

TGI-5 is a novel immunological checkpoint monoclonal antibody drug independently developed by TGI, with proprietary intellectual property rights, classified as a Class 1 biological new drug. Its proposed indications include the treatment of liver cancer, colorectal cancer, and lung cancer, demonstrating high anti-tumor activity and excellent drug-like properties. Relevant sources indicate that TGI-5, as one of TGI's core clinical pipeline products, holds the potential to treat various types of cancer.
 

It is reported that 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. Moreover, TGI-5 has a synergistic anti-cancer effect with PD-1 therapy.
 

Relevant sources also indicated that with the approval of TGI-5's new drug clinical trial application in China, the company now has three drugs in the clinical development stage.
 

According to reports, in addition to TGI-5, the clinical trial application (IND) for TGI's independently developed anti-PVRIG monoclonal antibody injection (project code TGI-2/NM1F) for the treatment of solid tumors was approved by China's National Medical Products Administration (NMPA) in April 2023. The product received implied permission from the U.S. FDA on December 17, 2022.
 

TGI-2 is a recombinant humanized IgG1 monoclonal antibody that can bind to PVRIG with high affinity and specificity, effectively blocking the binding of PVRIG to 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 has significant anti-cancer effects, and when used in combination with anti-PD-1 monoclonal antibodies, it can further enhance anti-cancer immunity.
 

In addition, in November 2023, the Phase I clinical study of TGI-6, a bispecific antibody independently developed by TGI, was approved by the National Medical Products Administration (NMPA) of China. Data shows that TGI-6 is a novel and highly potent bispecific antibody independently developed by TGI. As an antibody drug targeting a completely new drug target, TGI-6 exhibits high anti-tumor activity, good drug-like properties, and potential safety, and is mainly used for treating colorectal cancer and other solid tumors positive for tumor-associated antigens.
 

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