Definition

A personalized cancer vaccine consisting of patient-specific neoantigen-coding DNA plasmids, which are immunogenic and unique to the patient’s tumor, with potential immunomodulating and antineoplastic activities. Upon administration of GNOS-PV01, the patient-specific neoantigens are translated in cells and elicit a specific and potent cytotoxic T-lymphocyte (CTL) response against tumor cells expressing these neoantigens, resulting in tumor cell lysis. Each patient specific formulation may contain multiple DNA plasmids, and each plasmid may contain multiple neoantigen DNA sequences, allowing the delivery of multiple neoantigen DNA sequences simultaneously.