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This personalized neoantigen peptide-based vaccine is an investigational immunotherapy developed by the Mayo Clinic for the treatment of advanced solid tumors, including triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC). The vaccine is custom-tailored for each patient by identifying unique tumor-specific mutations (neoantigens) through DNA and mRNA sequencing of the patient's tumor tissue using the REAL-neo bioinformatics pipeline. The active pharmaceutical ingredient consists of a pool of up to 20 synthetic long peptides, manufactured by Pepscan, which are designed to elicit a robust T-cell mediated immune response against the tumor cells. In clinical trials (e.g., PNeoVCA, NCT05269381), the vaccine is administered subcutaneously in combination with the adjuvant sargramostim (GM-CSF) and the checkpoint inhibitor pembrolizumab to maximize therapeutic efficacy.
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