On June 16, 2023 TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company focused on the development of novel immuno-oncology therapies, reported that the FDA has granted clearance for the clinical trial of TGI-6, its groundbreaking bispecific antibody (Press release, TG Immunopharma, JUN 16, 2023, View Source [SID1234632757]). TGI-6 targets unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, enabling potent anti-tumor responses. The antibody demonstrates exceptional anti-tumor activity, favorable safety profiles, and remarkable druggability.
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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 Professor Zhigang Tian, founder of TGI and member of the Chinese Academy of Engineering and the Academia Europaea. "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."
With this significant milestone, TGI 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 their expertise in clinical development and market access, expediting the availability of TGI-6 for patients worldwide.
TGI remains steadfast in its mission to revolutionize cancer treatment through innovative immunotherapies. With FDA clearance for the clinical trial of TGI-6, the company is poised to advance the development of precise therapies for solid tumors. Interested parties are invited to explore partnership opportunities and join TGI in their pursuit of delivering novel treatment options that improve patient outcomes.