Hefei, China, 16 June 2023 - TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company focused on the development of novel immuno-oncology therapies, is pleased to announce that the FDA has granted clearance for the clinical trial of TGI-6, its groundbreaking bispecific antibody. 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.

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.  

About TG ImmunoPharma Co., Ltd. (TGI)

TG ImmunoPharma Co., Ltd. (TGI) is a leading biotech company dedicated to the development of novel immunotherapeutic drugs. Focusing on innovation and research, TGI harnesses the power of the immune system to combat cancer and enhance patient outcomes. The company's diverse pipeline includes bispecific antibodies, immune checkpoint inhibitors, NK/T-cell engagers, and immunocytokines. TGI has successfully developed over 10 pipeline products, with more than half having completed pre-clinical studies. Notably, TGI-2, an anti-PVRIG therapeutic antibody, has initiated Phase 1 trials in the United States and is nearing completion of its first patient dosing. TGI envisions three innovative drugs entering Phase I trials by the end of next year, demonstrating its commitment to advancing immunotherapy and addressing unmet needs in cancer treatment worldwide. To learn more about TGI and its pipeline, please visit www.tgimmunopharma.com.

For further information or partnership inquiries, please contact:

Dr. SUN Haoyu,

Head of Operation, TG ImmunoPharma

haoyu.sun@tgimmunopharma.com