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The personalized mRNA tumor vaccine is an investigational immunotherapy developed by Changhai Hospital (Naval Medical University, Shanghai) in collaboration with Stemirna Therapeutics for the treatment of advanced gastrointestinal cancers. Utilizing a patient-specific approach, the vaccine is designed based on whole exome sequencing (WES) and RNA sequencing of an individual's tumor to identify unique somatic mutations. It encodes up to 20 tumor-specific neoantigens, which are delivered via mRNA to stimulate a robust T-cell immune response against the cancer cells. The vaccine is administered subcutaneously and is currently being evaluated in Phase I/II clinical trials (notably NCT03468244) for patients with esophageal squamous cell carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, and colorectal adenocarcinoma who have progressed after standard first-line chemotherapy.
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