TianGang Yinuo Announces FDA Clearance of IND Application for TGI-6, a Novel Bispecific Antibody Targeting Solid Tumors

HefeiJune 16, 2023PR Newswire -- Hefei TG ImmunoPharma Co., Ltd. (TGI) today announced that its independently developed bispecific antibody (project code TGI-6) has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). A Phase I clinical study will be initiated in the United States soon. Currently, no products targeting the same site have been approved for marketing in China or globally.

TGI-6 is a novel, potent bispecific antibody independently developed by TGI. As an antibody drug targeting a completely new drug target,TGI-6 has the characteristics of high anti-tumor activity, good drugability, and good potential safety.Mainly used for the treatment of colorectal cancer and other solid tumors with positive tumor-associated antigens.

TGI-6 can simultaneously and specifically bind to tumor-associated antigens on the surface of tumor cells and CD3 molecules on the surface of T cells, strongly activating T cells and killing tumor cells. TGI-6 is designed with high-affinity binding to tumor targets and low-affinity binding to CD3, ensuring high killing activity while reducing the risk of cytokine storms. TGI-6 can target multiple solid tumors, including colorectal cancer, breast cancer, hepatocellular carcinoma, gastric cancer, ovarian cancer, and pancreatic cancer. Preclinical studies have shown that a single dose of this antibody has the ability to completely eliminate tumors in animal models of colorectal cancer, demonstrating potent anti-tumor activity. The product was provided with IND submission services by two strategic partners of TGI: Clinipace (formerly dMed-Clinipace) and GenScript ProBio, which also offered preclinical CMC services.

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 of TGI-6's IND approval. Currently, the only competing drug with the same target globally is undergoing Phase I clinical trials. Compared to the competitor, TGI-6 demonstrates stronger anti-tumor activity and potential clinical safety. Meanwhile, there is still much for us to explore. The TGI team has already begun more in-depth research on the next phase of the project. TGI adheres to an independent innovation route. In the NK cell field, we have over 10 product pipelines progressing as planned, hoping to bring more novel therapies to patients worldwide."