TG ImmunoPharma (TGI) announces FDA clearance of IND application for TGI-2, a novel anti-PVRIG therapeutic antibody

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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 http://www.tgimmunopharma.com.

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.