mRNA Immunomodulator Combination for Coordinated Vaccine Expression
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Solution Overview
Problem
Existing mRNA vaccines and gene therapy approaches face suboptimal adaptive immunity due to the detrimental effect of adjuvants on antigen expression, leading to reduced potency, quality, and longevity of the immune response.
Innovation Solution
Administering a combination of mRNA vaccines or therapeutic mRNA with one or more mRNA molecules having direct or indirect immunomodulating activity, either as a mixture of lipid nanoparticle formulations or co-formulated in a single particle, or encoded in a single mRNA molecule, to achieve spatially and temporally coordinated in vivo expression of therapeutic and immunomodulatory proteins.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If adjuvants are added to mRNA vaccines to enhance adaptive immunity, then immune response potency is improved, but antigen expression is detrimentally affected
Solution Approach 1:
The patent uses an mRNA-encoded immunomodulator as an intermediary substance that mediates between the antigen and the immune system. Instead of using traditional adjuvants that directly interact with the antigen and cause harmful effects, the immunomodulator is encoded by mRNA that is co-administered with the antigen mRNA, allowing it to be produced endogenously and modulate the immune response without the detrimental effects of exogenous adjuvants
Solution Approach 2:
The patent replaces the mechanical/chemical system of traditional adjuvants (aluminum salts, oil emulsions, CpG ODN) with a biological system where immunomodulatory proteins are expressed from mRNA. This substitution allows for more precise and controllable immune modulation through endogenous protein production rather than exogenous adjuvant administration
2Reliability
If traditional adjuvants are used with mRNA vaccines, then adaptive immunity is enhanced, but the quality and longevity of immune response are reduced
Solution Approach 1:
The patent applies preliminary action by co-administering mRNA that encodes immunomodulators along with the antigen mRNA. This allows the immunomodulatory proteins to be produced at the same time and location as the antigen, creating an optimal immune environment from the outset rather than relying on adjuvants that may have suboptimal timing or localization
Solution Approach 2:
The patent merges the antigen delivery and immune modulation functions into a single mRNA-based system. Both the antigen and the immunomodulator are encoded by mRNA molecules that are co-administered, ensuring they are produced in the same cells and locations, thereby enhancing the quality and longevity of the immune response through coordinated expression
3Productivity
If mRNA vaccines are administered without immunomodulators, then antigen expression is maintained, but immune response potency is suboptimal
Solution Approach 1:
The patent segments the immune response enhancement function from the antigen expression function by using separate mRNA molecules: one encoding the antigen and another encoding the immunomodulator. This segmentation allows each mRNA to be optimized for its specific function while both contribute to the overall immune response
Solution Approach 2:
The immunomodulator encoded by the second mRNA acts as an intermediary that bridges the antigen and the immune system. It is produced from the co-administered mRNA and modulates the immune response to the antigen, enhancing potency without interfering with antigen expression
Data Source
AI summary
The present invention pertains to a combination comprising two or more mRNA molecules, or a single mRNA molecule encoding a first molecule, which is a therapeutic or immunogenic protein or peptide, and a second molecule, which is a protein or a peptide having the ability to modulate an immune response against the first molecule and/or the translation product of the first molecule, wherein the combination comprises at least one first mRNA molecule encoding a first molecule, which is a therapeutic or immunogenic protein or peptide, and at least one second mRNA molecule encoding a second molecule, which is a protein or a peptide having the ability to modulate an immune response against the first molecule and/or the translation product of the first molecule. The invention also relates to a host cell comprising a combination or the single mRNA molecule according to the present invention, a pharmaceutical composition comprising the combination, the single mRNA molecule, or the host cell of the present invention, and a vaccine comprising the combination, the single mRNA molecule, the host cell, or the pharmaceutical composition according to the present invention. Further provided is a kit comprising the combination, the single mRNA molecule, the host cell, the pharmaceutical composition, or the vaccine according to the present invention. The invention also pertains to the combination, the single mRNA molecule, the host cell, the pharmaceutical composition, the vaccine, or the kit according to the present invention, for use in medicine. Finally, the invention also relates to the combination, the single mRNA molecule, the host cell, the pharmaceutical composition, the vaccine, or the kit according to the present invention, for use in a method of prevention, and/or treatment of an infectious, a genetic, or a proliferative disease.