TG ImmunoPharma Co., Ltd. (TGI), which is focused on developing new immuno-oncology therapeutics, said the FDA has granted approval for clinical trials of TGI-6, its bispecific antibody.
TGI-6 targets unique tumor-associated antigen (TAA) and CD3 molecules simultaneously, enabling a potent anti-tumor response. TGI says the antibody exhibits outstanding anti-tumor activity, a favorable safety profile and outstanding medicinal properties.
TGI-6 TAA is highly expressed in a variety of solid tumors, including colorectal cancer, breast cancer, hepatocellular carcinoma, gastric cancer, ovarian cancer, pancreatic cancer, and many others. This makes TGI-6 a promising candidate for the treatment of various solid tumors.
Preclinical studies have shown remarkable potential, with TGI-6 inducing complete tumor regression in animal models of colorectal cancer after a single administration. Importantly, TGI-6 was designed to maintain high cytotoxic activity while minimizing the risk of cytokine release syndrome (CRS).
“We are very pleased to receive FDA clearance for clinical trials of TGI-6,” said Zhigang Tian, founder of TGI.
“TGI-6 has demonstrated superior anti-tumor activity and safety in preclinical studies. We are very confident in its potential as a new therapy for solid tumors.”
TGI 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, accelerating the availability of TGI-6 to patients worldwide.
TGI says its mission is to revolutionize cancer treatment through innovative immunotherapies.