Clearance for anti-tumor bispecific antibody trial

TG ImmunoPharma Co., Ltd. (TGI), which focuses on the development of novel immuno-oncology therapies, says the FDA has granted clearance for the clinical trial of TGI-6, its bispecific antibody. 

TGI-6 targets unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, enabling potent anti-tumor responses. TGI said the antibody demonstrates exceptional anti-tumor activity, favorable safety profiles, and remarkable druggability.

TGI-6’s TAA is highly expressed in various solid tumors, including colorectal cancer, breast cancer, hepatocellular carcinoma, gastric cancer, ovarian cancer, pancreatic cancer, and more. This makes TGI-6 a promising candidate for the treatment of a wide range of solid tumors. 

Preclinical studies have shown outstanding potential, with TGI-6 inducing complete tumor regression in animal models of colorectal cancer following a single administration. Importantly, TGI-6 is designed to maintain high cytotoxic activity while minimizing the risk of cytokine release syndrome (CRS).

“We are thrilled to receive FDA clearance for the clinical trial of TGI-6,” said Zhigang Tian, founder of TG ImmunoPharma. 

“TGI-6 has demonstrated superior anti-tumor activity and safety in preclinical studies. We have great confidence in its potential as a novel therapy for solid tumors.”

TG ImmunoPharma said it is actively seeking global partners to collaborate on the development, clinical trials, and eventual commercialization of TGI-6. By partnering with pharmaceutical and biotechnology companies, TGI aims to leverage its experience in clinical development and market access, expediting the availability of TGI-6 for patients worldwide.

TG ImmunoPharma said its mission is to revolutionize cancer treatment through innovative immunotherapies.