TG ImmunoPharma (TGI) announces FDA clearance of IND application for TGI-2, a novel anti-PVRIG therapeutic antibody
2022-12-17
免疫疗法临床申请
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 inhibitorPD-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
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