FDA granted Orphan Drug Designation for MTG-201, a therapy targeting Dickkopf-3 gene defects in various cancers, for the treatment of malignant mesothelioma.
The Dickkopf-3 gene produces a protein called REIC (Reduced Expression in Immortalized Cells protein), which is a critical protein in the downstream mechanism of apoptosis and when absent cancer cells cannot die.
By expressing REIC protein from within cancer cells, MTG-201 induces selective apoptosis due to ER stress, directly killing the cancer and reducing cancer burden. MTG-201 also stimulates the production of activated T-cell lymphocytes that specifically target and destroy residual cancer cells.
MTG-201, developed by MTG Biotherapeutics, is currently in phase I clinical trials for the treatment of prostate cancer and mesothelioma. Preclinical programs are ongoing for the treatment of liver and bladder cancers. MTG-201 is also being evaluated for efficacy in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 antibodies.
