# US 12,005,112 B2 · Vaccine molecules

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- Number: US 12,005,112 B2
- Document ID: US12005112B2
- Status: Granted
- Kind: B2
- Application number: 16/645,135
- Filed: 2018-09-07
- Published: 2021-03-11
- Granted: 2024-06-11
- Earliest claimed: 2017-09-07
- Assignees: University of Oslo
- Applicants: University of Oslo
- Inventors: Gunnveig Grødeland; Bjarne Bogen; Ane Marie Anderson
- Web page: https://patentgrep.com/patent/US12005112B2

## CPC

- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61P 31/16: for influenza or rhinoviruses
- C07K 14/005: from viruses
- C07K 14/11: Orthomyxoviridae, e.g. influenza virus
- C07K 16/2833: {against MHC-molecules, e.g. HLA-molecules}
- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/575: {humoral response}
- C07K 2317/526: CH3 domain
- C07K 2317/53: Hinge
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/64: comprising a combination of variable region and constant region components
- C07K 2319/33: fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
- C07K 2319/40: containing a tag for immunodetection, or an epitope for immunisation
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Provided herein is technology relating to vaccines and particularly, but not exclusively, to compositions, methods, and uses of a mixture of immunogenic vaccine molecules comprising components for targeting the dimeric vaccine molecules to antigen-presenting cells and components for eliciting an immunogenic response, wherein the components for eliciting an immunogenic response preferably comprise at least three variants of an immunogenic protein, such as variants of immunogenic proteins obtained from three or more different strains of a pathogenic organism.

## Claims

### Claim 1

A DNA vaccine comprising three or more different nucleic acid constructs, each of said constructs encoding a fusion protein comprising a targeting unit, a multimerization domain, and an antigenic unit in operable association, wherein said antigenic unit for each of said three or more different nucleic acid constructs differ by encoding different variant target antigenic proteins and wherein when said three or more different nucleic acid constructs are introduced into a cells a random mixture of multimeric protein molecules comprising the same and different variant target antigenic proteins are produced via association of said multimerization domains.

### Claim 2 (depends on 1)

The DNA vaccine of claim 1, wherein said multimeric protein molecule is a dimeric protein molecule and multimerization domain is a dimerization domain.

### Claim 3 (depends on 2)

The DNA vaccine of claim 2, wherein said multimerization domain is a hinge/CH3 dimerization domain.

### Claim 4 (depends on 1)

The DNA vaccine of claim 1, wherein said targeting unit is an antigen binding protein.

### Claim 5 (depends on 4)

The DNA vaccine of claim 4, wherein said antigen binding protein is an scFv.

### Claim 6 (depends on 1)

The DNA vaccine of claim 1, wherein said targeting unit is an Antigen Presenting Cell (APC) targeting unit.

### Claim 7 (depends on 6)

The DNA vaccine of claim 6, wherein said APC targeting unit binds to a target selected from the group consisting of MHC-II molecules, CD40, CD14, HLA-DP, Toll-like receptors, and chemokine receptors.

### Claim 8 (depends on 1)

The DNA vaccine of claim 1, wherein said different variant antigenic target proteins have greater than about 30%, 40%, 50%, 60%, 70%, 80%, 90% or 95% sequence identity.

### Claim 9 (depends on 1)

The DNA vaccine of claim 1, where said different variant antigenic target proteins are from different strains of an organism.

### Claim 10 (depends on 9)

The DNA vaccine of claim 9, wherein said organism is a pathogenic organism.

### Claim 11 (depends on 1)

The DNA vaccine of claim 1, wherein said different variant antigenic target proteins are variants of hemagglutinin (HA).

### Claim 12 (depends on 11)

The DNA vaccine of claim 11, wherein said vaccine comprises variants of HA from at least three, four, five or six strains of influenza viruses.

### Claim 13 (depends on 12)

The DNA vaccine of claim 12, wherein said influenza viruses are group 1 influenza viruses.

### Claim 14 (depends on 13)

The DNA vaccine of claim 13, wherein said group 1 influenza viruses are selected from the group consisting of H5, H6, H8, H9, H11, and H13.

### Claim 15 (depends on 1)

The DNA vaccine of claim 1, wherein said different variant antigenic target proteins are variants of a cancer antigen.

### Claim 16 (depends on 2)

The DNA vaccine of claim 2, wherein said random mixture of dimeric protein molecules comprises a defined number of different dimeric molecules, where said defined number of different dimeric molecules is calculated by the formula [n(n+1)]/2 where n is the number of different variant antigenic target proteins.

### Claim 17 (depends on 16)

The DNA vaccine of claim 16, wherein the number of different dimeric molecules is 6 when n is 3, 10 when n is 4, 15 when is n 5 and 21 when n is 6.

### Claim 18 (depends on 1)

The DNA vaccine of claim 1, wherein the sequence encoding the fusion protein is operably linked to a promoter.

### Claim 19 (depends on 1)

A method of immunizing or inducing an immune response to variant target antigenic proteins in a subject comprising administering to said subject a DNA vaccine according to claim 1 to a subject.