TG ImmunoPharma (TGI) Announces FDA Approval of IND Application for TGI-2, a New Therapeutic Anti-PVRIG Antibody

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”.

About TGI

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.

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’, ‘plans’, ‘target’, ‘estimates’, ‘probable’, ‘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, as they are based on management’s current expectations and beliefs about future events as of this date. These statements are not guarantees of future performance and are subject to risks, uncertainties and other factors beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from those expressed or anticipated forward appearance statements. Factors that could cause actual results to differ materially 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 political, economic, legislative, regulatory or political changes.

Accordingly, neither the Company nor any employee will undertake any obligation to update these forward-looking statements or assume any obligation if actual results differ materially from those anticipated in the forward-looking statements.

SOURCE TG ImmunoPharma Co., Ltd.

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