Medigene's Next-Generation TCR-T Therapy MDG1015 Receives FDA IND Approval for Phase 1 Clinical Trial in Solid Tumors

RecentlyMedigene Announces FDA Approval of IND Application for Lead Candidate MDG1015, Phase 1 Clinical Trial to Commence in Patients with Advanced Gastric Cancer, Ovarian Cancer, Myxoid/Round Cell Liposarcoma, and Synovial Sarcoma

MDG1015 is a potential "first-in-class" third-generation T-cell receptor (TCR) engineered T-cell therapy targeting NY-ESO-1/LAGE-1a, with its TCR capable of specifically recognizing the target while demonstrating high safety and sensitivity.These TCR-T cells are further enhanced by the addition of a proprietary PD1-41BB co-stimulatory switch protein (CSP) technology, demonstrating significantly enhanced anti-tumor activity against tumor cells expressing varying levels of PD-L1.

Compared with the first generation of TCR-T therapy, the production process of MDG1015 is faster, requiring only 6 days to expand the cells needed for treatment. These cells are younger and healthier, potentially requiring fewer cells for treatment. The entire treatment process, from collecting the patient's cells to infusion, is shortened to approximately 20 days. Moreover, nearly all generated MDG1015 cells are CD8+ cells, with about 95% of them exhibiting stem cell-like characteristics, meaning they can survive longer in the body, providing more sustained therapeutic effects while potentially reducing adverse events.

Medigene AG is a biotechnology company focused on T-cell receptor (TCR) cancer immunotherapy. The company's end-to-end development platform can generate optimized TCRs with unique differentiation characteristics that combine sensitivity, specificity, and safety. These TCRs are suitable for various drug molecule formats, including T-cell receptor-engineered T-cell therapy (TCR-T), TCR-mediated T-cell engager (TCE) therapy, and TCR NK cell therapy, among others. They are widely applied in the company’s proprietary R&D pipeline as well as in collaborative drug molecule development.

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