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This investigational RNA tumor vaccine is an mRNA-based biologic developed by the First Affiliated Hospital of Bengbu Medical University for the treatment of advanced solid tumors harboring KRAS mutations. The vaccine encodes specific KRAS neoantigen peptides, specifically targeting the G12C, G12D, and G12V variants. These peptides are designed to be presented by specific human leukocyte antigen (HLA) types, namely HLA-A*11:01 or HLA-C*08:02, to stimulate a robust cytotoxic T lymphocyte (CTL) response against tumor cells expressing these oncogenic drivers. Currently in Phase 1 clinical development (NCT05202561), the vaccine is being evaluated as a monotherapy and in combination with PD-1 inhibitors such as nivolumab (referred to as Navuliumab in some contexts) or pembrolizumab to potentially enhance the anti-tumor immune response in patients with pancreatic, colorectal, and lung cancers.
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