HEFEI, China, December 16, 2022 /PRNewswire/ — TG ImmunoPharma Co., Ltd. (Hefei, China), an innovative immunotherapy drug discovery biotech company and a global leader in NK cell research, 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 therapeutic anti-PVRIG 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 malignancies. 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 non-human primates. Treatment with TGI-2/NM1F as monotherapy demonstrates significant inhibition of tumor growth in human tumor xenograft mouse models, while further enhancing 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 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,” he said Zhigan Tian, PhD, Members of Chinese Academy of Engineering and Academia Europaea, Founder of TGI. “We are excited to initiate a multi-center Phase 1 clinical trial across the United States for patients with advanced solid tumors and for whom standard-of-care therapies are currently ineffective, requiring innovative medicines in the near future. Additionally, IND in China should be presented shortly”.
TGI is a biotech company founded by the R&D team led by Dr. Zhigan Tian, members of the Chinese Academy of Engineering and Academia Europaea, dedicated to the development of new immunotherapy drugs. As one of the leaders in NK cell research globally and aiming to strengthen the anti-tumor function of human NK cells and other lymphocytes, the team has been focused for years on discovering new targets for cancer immunotherapy. The company’s therapeutic pipeline consists of more than 10 products against newly discovered targets, including immune checkpoint inhibitors, bispecific antibodies, NK/T cell activators, and immunocytokines. For more information, visit TGI’s website at http://www.tgimmunopharma.com.
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SOURCE TG ImmunoPharma Co., Ltd.