TG ImmunoPharma Receives FDA Approval for Phase I Clinical Study of TGI-6 Bispecific Antibody

China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its bispecific antibody (BsAb), TGI-6. This development marks a significant step forward in the company’s efforts to bring innovative immunotherapies to patients with solid tumors.

TGI-6’s Mechanism of Action and Clinical Potential
TGI-6 is designed to specifically bind to both tumor-associated antigens on the surface of tumor cells and CD3 molecules on the surface of T cells, strongly activating T cells and inducing the killing of tumor cells. The drug’s unique design features high affinity binding to the tumor target and low affinity binding to CD3, which allows for high killing activity while reducing the risk of cytokine release syndrome (CRS), commonly known as cytokine storm.

Broad Application in Solid Tumor Treatments
TGI-6 has the potential to target a variety of solid tumors, including colorectal cancer, breast cancer, hepatocellular carcinoma, gastric cancer, ovarian cancer, and pancreatic cancer. Preclinical studies have demonstrated the antibody’s ability to completely eliminate tumors in a single dose in animal models of colorectal cancer, highlighting its strong anti-tumor activity.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry