The GNTbm R&D team has independently developed a new structural epigenetic immunoactivator, named GNTbm-38, after years of R&D. It is a dual-function drug that has been screened for innovative, small-molecule, oral, and excellent epigenetic regulation and immune modulation activities. Studies on enzyme, cell, and animal test platforms have shown that GNTbm-38 has excellent epigenetic and immune modulation activities. When used in combination with TKIs that inhibit specific targets, it demonstrates very superior activity in remodeling the TME, significantly increasing the tumor response rate. GNTbm-38 can be used as a monotherapy or in combination with TKIs that inhibit specific targets for cancer immunotherapy. The chemical structure of GNTbm-38 falls under the category of benzamide-based, serving as a selective class I HDAC inhibitor. GNTbm has obtained multiple invention patents, including in the United States. GNTbm-38 is one of the essential components in cancer combination immunotherapy.
The GNTbm-38 pre-clinical studies have been successfully completed, and an IND will be applied to conduct a Phase 1 clinical trial, followed by a Phase 2 clinical trial, with R/R PTCL as the first indication. An application for orphan drug designation in the United States will be submitted. Once the R/R PTCL drug approval is obtained, new indications will be expanded, by using 'GNTbm-38 + Z’, where Z could be a TKI that inhibits unique targets or a anti-PD-1/VEGF bispecific antibody, for treatment of various advanced solid tumors.