US20260124285
2026-05-07
Human necessities
A61K39/0011
Personalized mRNA cancer vaccines are designed to target specific mutations found in an individual's tumor. These vaccines aim to induce an immune response against cancer cells by administering a tailored vaccine to the patient. The process involves the use of biomarkers to identify suitable candidates and predict their response to the vaccine, optimizing its efficacy in stimulating an immune response.
The method for inducing an immune response involves three main steps. First, an immune checkpoint inhibitor is administered to the patient. Second, biomarkers are measured from a biological sample collected from the patient, either before or on the day of administering the vaccine. Finally, a personalized cancer vaccine is given to the patient, containing mRNA encoding cancer antigen epitopes and delivered via a lipid vehicle, to provoke an immune response against the tumor.
Biomarkers play a crucial role in this method, as they help determine the patient's suitability for the vaccine. These include tumor mutational burden (TMB), T cell-inflamed gene expression profile (GEP) score, T cell cytotoxicity activity (CYT) score, PD-L1 expression, minimal residual disease (MRD) level, and γδ T cells. The levels of these biomarkers are compared to predetermined reference values to assess patient eligibility and potential response.
The personalized cancer vaccine uses a lipid delivery vehicle, which may include lipid nanoparticles, liposomes, or lipoplexes. These vehicles are composed of various lipids, such as ionizable cationic lipids, neutral lipids, cholesterol, and PEG-modified lipids, in specific molar ratios. This composition ensures efficient delivery of the mRNA to the target cells, enhancing the vaccine's effectiveness.
Checkpoint inhibitors are critical components of this method, as they help enhance the body's immune response to the vaccine. These inhibitors can be antibodies or fragments that specifically bind to molecules like PD-1, CTLA-4, and others. An example is the anti-PD-1 antibody pembrolizumab, which can be used alone or in combination with the personalized vaccine to improve patient outcomes.