TG ImmunoPharma Co., Ltd, based in China, has announced that it has received Investigational New Drug (IND) approval from the U.S. FDA for its proprietary monoclonal antibody (mAb), TGI-5. While the specific target of this molecule remains undisclosed, the company claims it could be a potential global first-in-class treatment.
TGI-5 is characterized as an innovative immune checkpoint antibody, demonstrating high anti-tumor activity and favorable medicinal properties. The drug is being developed for indications including liver cancer, colorectal cancer, and lung cancer, among others. Upon binding to its target, TGI-5 is designed to restore the anti-cancer immune functions of natural killer (NK) cells and T cells.
Preclinical studies have indicated that TGI-5 exhibits robust anti-tumor efficacy in animal models, outperforming PD-1 antibodies in conditions such as liver cancer, colorectal cancer, and melanoma. Additionally, TGI-5 has shown synergistic anti-cancer effects when combined with PD-1 therapy. The IND filing was supported by partners Caidya (formerly dMed-Clinipace) and GenScript ProBio, who provided pre-clinical CMC services.- Flcube.com
