Hefei TG ImmunoPharma Co., Ltd

HEFEI, China, June 16, 2023 /PRNewswire/ -- 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 . For further information or partnership inquiries, please contact: Dr. SUN Haoyu, Head of Operation, TG ImmunoPharma [email protected] SOURCE TG ImmunoPharma Co., Ltd.

HEFEI, China, Dec. 17, 2022 /PRNewswire/ -- TG ImmunoPharma Co., Ltd. (Hefei, China), an innovative biotech company dedicated to the discovery of novel immunotherapeutic drugs and a leader in NK cell research globally, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TGI-2/NM1F, a novel anti-PVRIG therapeutic antibody used in patients with advanced solid tumors. Currently, no drugs targeting PVRIG have been approved globally. TGI-2/NM1F is a humanized IgG1 monoclonal antibody targeting PVRIG for the treatment of malignant cancers. The antibody binds to PVRIG with high affinity to block the PVRIG/PVRL2 interaction and restore the antitumor immune functions of both NK cells and T cells. Preclinical data suggest that TGI-2/NM1F has a long half-life and is well tolerated at very high doses in nonhuman primates. Treatment with TGI-2/NM1F as a monotherapy demonstrates significant inhibition of tumor growth in human tumor xenograft mouse models, while it further enhances the antitumor effect in combination with a PD-1 inhibitor. "It is a significant milestone for TGI, having received clearance from the FDA to advance TGI-2 into the clinical trials. TGI-2 offers remarkable antitumor function and good safety, with higher affinity and lower onset dose than its competitors, making it highly promising for clinical use," stated Zhigang Tian, PhD, members of Chinese Academy of Engineering and Academia Europaea, Founder of TGI. "We are excited to initiate a phase 1 clinical trial in multiple centers in the U.S. for patients with advanced solid tumors and for whom standard of care therapies are currently ineffective, which demand innovative drugs in the near future. In addition, IND in China is expected to be submitted soon." About TGI TGI is a biotech company founded by the R&D team led by Dr. Zhigang Tian, members of the Chinese Academy of Engineering and Academia Europaea, dedicated to the development of novel immunotherapeutic drugs. As one of the leaders in NK cell research globally and with the goal of strengthening the antitumor function of human NK cells and other lymphocytes, the team has focused on the discovery of novel targets for cancer immunotherapy for years. The company's therapeutic pipeline consists of more than 10 products against novel targets it has discovered, including immune checkpoint inhibitors, bispecific antibodies, NK/T-cell engagers, and immunocytokines. For additional information, please visit TGI's website at . Forward-looking statement： This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," (collectively referred to as "forward-looking statements") and describe opinions about possible future events. These statements are subject to significant risks and uncertainties. The reader is cautioned not to rely on these forward-looking statements, for they are based on management's current expectations and beliefs of future events as of this date. These statements are not guarantees of future performance and are subject to risks, uncertainties and other factors which are beyond the Company's control and which may cause the actual results, performance or achievements of the Company to be materially different from those expressed or forecast in the forward-looking statements. Factors that could cause actual results to be materially different from those reflected in the forward-looking statements include but are not limited to (i) risks associated with our business or market competition; (ii) effects of changes in politics, economies, laws, regulations or policies. Therefore, neither the Company nor any employee shall assume obligation to update these forward-looking statements, or undertake any obligation if actual results differ materially from those anticipated in the forward-looking statements. SOURCE TG ImmunoPharma Co., Ltd.

HEFEI, China I Decemer 16, 2022 I TG ImmunoPharma Co., Ltd. (Hefei, China), an innovative biotech company dedicated to the discovery of novel immunotherapeutic drugs and a leader in NK cell research globally, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TGI-2/NM1F, a novel anti-PVRIG therapeutic antibody used in patients with advanced solid tumors. Currently, no drugs targeting PVRIG have been approved globally. TGI-2/NM1F is a humanized IgG1 monoclonal antibody targeting PVRIG for the treatment of malignant cancers. The antibody binds to PVRIG with high affinity to block the PVRIG/PVRL2 interaction and restore the antitumor immune functions of both NK cells and T cells. Preclinical data suggest that TGI-2/NM1F has a long half-life and is well tolerated at very high doses in nonhuman primates. Treatment with TGI-2/NM1F as a monotherapy demonstrates significant inhibition of tumor growth in human tumor xenograft mouse models, while it further enhances the antitumor effect in combination with a PD-1 inhibitor. "It is a significant milestone for TGI, having received clearance from the FDA to advance TGI-2 into the clinical trials. TGI-2 offers remarkable antitumor function and good safety, with higher affinity and lower onset dose than its competitors, making it highly promising for clinical use," stated Zhigang Tian, PhD, members of Chinese Academy of Engineering and Academia Europaea, Founder of TGI. "We are excited to initiate a phase 1 clinical trial in multiple centers in the U.S. for patients with advanced solid tumors and for whom standard of care therapies are currently ineffective, which demand innovative drugs in the near future. In addition, IND in China is expected to be submitted soon." About TGI TGI is a biotech company founded by the R&D team led by Dr. Zhigang Tian, members of the Chinese Academy of Engineering and Academia Europaea, dedicated to the development of novel immunotherapeutic drugs. As one of the leaders in NK cell research globally and with the goal of strengthening the antitumor function of human NK cells and other lymphocytes, the team has focused on the discovery of novel targets for cancer immunotherapy for years. The company's therapeutic pipeline consists of more than 10 products against novel targets it has discovered, including immune checkpoint inhibitors, bispecific antibodies, NK/T-cell engagers, and immunocytokines. For additional information, please visit TGI's website at http://www.tgimmunopharma.com . SOURCE: TGI