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Dubodencel (DOC1021) is an autologous, first-in-class, double-loaded dendritic cell (DC) immunotherapy developed by Diakonos Oncology. The therapy is manufactured from a patient's peripheral blood mononuclear cells (PBMCs) and uniquely loaded with both autologous tumor lysate and amplified tumor-derived mRNA. This "double-loading" approach is designed to mimic a viral infection, activating the p38MAPK and mTORC1 signaling cascades to initiate a potent Th1 immune response and the development of CD8+ cytolytic effector memory T cells. Dubodencel targets the complete cancer antigen pool without requiring genetic modification of the immune cells or preconditioning regimens like myeloablative chemotherapy. It is primarily being investigated for the treatment of aggressive solid tumors, including glioblastoma, pancreatic ductal adenocarcinoma, and refractory melanoma, and has received Fast Track and Orphan Drug designations from the FDA for glioblastoma.
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