The TGI-2 clinical trial application of Tiangang Innuo obtained implied approval from the US FDA

On December 17, 2022, the clinical trial of anti-PVRIG monoclonal antibody injection (project code TGI-2/NM1F) independently developed by Hefei Tiangang Immunological Drug Co.
, Ltd.
(Tiangang Yinuo) for the treatment of solid tumors received implied permission from the US Food and Drug Administration (FDA), and a phase I clinical study
will be carried out in the United States in the near future.
At present, no products targeting PVRIG have been approved for marketing
at home and abroad.

PVRIG, also known as CD112R, is an immunosuppressive receptor that is mainly expressed on the surface
of NK cells and T cells.
In the immunosuppressive microenvironment of tumor tissues, anti-cancer effector cells (such as NK cells and T cells) are "forced" to express PVRIG at ultra-high levels and appear inhibited and lose anti-cancer function
.
In short, tumor cells combine with the PVRIG of immune cells through high surface expression of PVRL2, thereby transmitting inhibitory signals to immune cells, weakening anti-cancer immunity, achieving immune escape, and promoting tumor development
.

NK cells are important killer cells and, together with T cells, form the core line of defense against tumor immunity
.
Academician Tian Zhigang, founder of Tiangang Yinuo, has been focusing on the basic and translational research of NK cells for more than 30 years, and found that targeting PVRIG can significantly restore the anti-cancer function of NK cells and mobilize the anti-cancer effect
of T cells.

TGI-2/NM1F is a recombinant humanized IgG1 monoclonal antibody targeting PVRIG for the treatment
of solid tumors.
The antibody binds to PVRIG with high affinity, blocks PVRIG/PVRL2 interaction, and restores the anti-tumor immune function
of NK cells and T cells.
Preclinical studies have shown that the antibody has a longer half-life and a highly tolerated dose
.
At the same time, in vivo efficacy experiments have shown that the antibody alone has significant anti-cancer function, and the combination with anti-PD-1 monoclonal antibody can further enhance anti-cancer immunity
.

According to Professor Tian Zhigang, a double academician of the Chinese Academy of Engineering and the European Academy of Sciences, and the founder of Tiangang Medical Nuo, "TGI-2 has significant anti-cancer function and good safety, and compared with competing products, the antibody has higher affinity and lower onset dose, which is very clinically promising
.
" We will conduct rigorous and prudent TGI-2 clinical studies
.
We are very pleased that TGI-2 will soon be approved for clinical trials in the United States and we are fully committed to advancing this Phase I clinical study
.
" At the same time, domestic clinical trials will also be submitted soon
.
”