On December 17, 2022 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, reported 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 (Press release, TG Immunopharma, DEC 17, 2022, View Source [SID1234625369]). Currently, no drugs targeting PVRIG have been approved globally.
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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.