# US 12,036,277 B2 · Vaccination with mRNA-coded antigens

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- Number: US 12,036,277 B2
- Document ID: US12036277B2
- Status: Granted
- Kind: B2
- Application number: 18/596,451
- Filed: 2024-03-05
- Published: 2024-06-20
- Granted: 2024-07-16
- Earliest claimed: 2011-03-02
- Assignees: CureVac AG
- Applicants: CureVac SE
- Inventors: Karl-Josef Kallen; Thomas Kramps; Margit Schnee; Benjamin Petsch; Lothar Stitz
- Web page: https://patentgrep.com/patent/US12036277B2

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/0011: {Cancer antigens}
- A61K 39/12: Viral antigens
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/12: Antivirals
- A61P 33/02: Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/5555: {Muramyl dipeptides}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- A61K 2039/572: {cytotoxic response}
- A61K 2039/585: {wherein the target is cancer}
- A61K 2039/6031: {Proteins}
- A61K 2039/622: {non-covalent binding}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to vaccines comprising at least one mRNA encoding at least one antigen for use in the treatment of a disease in an elderly patient preferably exhibiting an age of at least 50 years, more preferably of at least 55 years, 60 years, 65 years, 70 years, or older, wherein the treatment comprises vaccination of the patient and eliciting an immune response in said patient. The present invention is furthermore directed to kits and kits of parts comprising such a vaccine and/or its components and to methods applying such a vaccine or kit.

## Claims

### Claim 1

A method for stimulating a protective anti-influenza immune response in a patient, the method comprising administering an effective amount of a composition comprising at least two RNA molecules, wherein the RNA molecules encode influenza haemagglutinin (HA) antigens from at least three different strains of influenza, wherein the RNA comprises a G/C content in the coding sequence that is elevated relative to wild type RNA encoding the HA antigen, wherein the method stimulates a protective immune response in the patient, wherein said protective immune response in the patient comprises an enhanced T cell-mediated immune response as compared to an inactivated influenza vaccine, and wherein the enhanced T cell-mediated immune response is a CD8+ T cell-mediated immune response.

### Claim 2 (depends on 1)

The method of claim 1, wherein the composition is administered by intradermal or intramuscular injection.

### Claim 3 (depends on 1)

The method of claim 1, wherein the HA antigens are each independently a H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14 or H15 subtype.

### Claim 4 (depends on 1)

The method of claim 1, wherein at least one of the HA antigens is a H1 subtype.

### Claim 5 (depends on 1)

The method of claim 1, further comprising administering an effective amount of a composition comprising an RNA encoding at least a second influenza antigen.

### Claim 6 (depends on 5)

The method of claim 5, wherein the at least a second influenza antigen is an influenza neuraminidase, matrix protein, or nucleoprotein antigen.

### Claim 7 (depends on 5)

The method of claim 5, comprising administering an RNA encoding an influenza haemagglutinin (HA) antigen and an RNA encoding an influenza neuraminidase (NA) antigen.

### Claim 8 (depends on 7)

The method of claim 7, comprising administering RNAs encoding HA antigens and NA antigens from at least one H1N1 strain, at least one H3N2 strain, and at least one Influenza B strain.

### Claim 9 (depends on 1)

The method of claim 1, wherein the RNA molecules each comprise at least one nucleotide substituted with an analog of the naturally occurring nucleotide.

### Claim 10 (depends on 8)

The method of claim 8, wherein the at least one nucleotide substituted with an analog of the naturally occurring nucleotide comprises a backbone modification, a sugar modification, or a base modification.

### Claim 11 (depends on 1)

The method of claim 1, wherein the RNA molecules are mRNA molecules and comprise a 5′ cap structure.

### Claim 12 (depends on 11)

The method of claim 11, wherein the mRNA molecules further comprise a poly-A sequence positioned 3′ of the coding region.

### Claim 13 (depends on 12)

The method of claim 12, wherein the mRNA molecules comprise a 5′ nontranslated region and/or a 3′ non-translated region.

### Claim 14 (depends on 12)

The method of claim 12, wherein the mRNA molecules comprise at least three of the following features:
(i) a 5′ cap structure;
(ii) a 5′ non-translated region;
(iii) a 3′ non-translated region;
(iv) a poly-A positioned 3′ of the coding region; and
(v) optionally, a poly-C sequence positioned 3′ of the coding region.

### Claim 15 (depends on 12)

The method of claim 12, wherein the HA antigens from at least four three different strains of influenza comprise an HA antigen from at least one H1N1 strain and an HA antigen from at least one H3N2 strain.

### Claim 16 (depends on 12)

The method of claim 12, wherein the HA antigens from at least four three different strains of influenza comprise an HA antigen from at least one Influenza A strain and an HA antigen from at least one Influenza B strain.

### Claim 17 (depends on 16)

The method of claim 16, wherein the HA antigens from at least four three different strains of influenza comprise HA antigens from at least one H1N1 strain, at least one H3N2 strain, and at least one Influenza B strain.

### Claim 18 (depends on 12)

The method of claim 12, wherein the mRNA molecules are associated with a vehicle, transfection, or complexation agent suitable for increasing the transfection efficiency of the mRNA molecules.

### Claim 19 (depends on 18)

The method of claim 18, wherein the vehicle, transfection, or complexation agent comprises cationic or polycationic compounds selected from cationic or polycationic peptides or polypeptides, cationic or polycationic polymers, or cationic or polycationic lipids.

### Claim 20 (depends on 18)

The method of claim 18, wherein the vehicle, transfection, or complexation agent are lipid particles.

### Claim 21 (depends on 18)

The method of claim 18, wherein the vehicle, transfection, or complexation agent is protamine.

### Claim 22 (depends on 1)

The method of claim 1, wherein the RNA molecules comprise a G/C content in the coding sequence that is increased at least 7% relative to a wild type mRNA encoding the HA antigen.

### Claim 23 (depends on 1)

The method of claim 1, further comprising administering the composition at least two times.

### Claim 24 (depends on 1)

The method of claim 1, wherein each of the influenza HA antigens is encoded on a separate RNA molecule.