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MDG1015 is a first-in-class, third-generation T cell receptor engineered T cell (TCR-T) therapy developed by Medigene. It targets the cancer-testis antigens New York esophageal squamous cell carcinoma 1 (NY-ESO-1) and L Antigen Family Member-1a (LAGE-1a) in the context of human leukocyte antigen HLA-A*02. The therapy uses a natural and optimal affinity "3S" TCR that is specific, sensitive, and safe. To enhance anti-tumor activity and persistence in the tumor microenvironment, these TCR-T cells are further armored with Medigene’s proprietary PD1-41BB costimulatory switch protein (CSP), which blocks the PD1/PD-L1 inhibitory axis while activating through the 4-1BB pathway. This design aims to overcome immunosuppressive signals from solid tumors and improve efficacy and durability of response while reducing adverse events. Manufacturing involves a short 6-day expansion period resulting in younger CD8+ cells with high stemness (~95%), potentially leading to better clinical outcomes. MDG1015 is being developed for multiple solid tumor indications including advanced cancers such as gastroesophageal junction adenocarcinoma, myxoid liposarcoma, ovarian epithelial carcinoma, soft tissue sarcoma, synovial sarcoma, advanced gastric carcinoma, and other solid tumors[1][2][3][4][5][7].
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