# US 10,369,204 B2 · Molecular vaccines for infectious disease

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- Number: US 10,369,204 B2
- Document ID: US10369204B2
- Status: Granted
- Kind: B2
- Application number: 13/122,007
- Filed: 2009-10-02
- Published: 2012-10-11
- Granted: 2019-08-06
- Earliest claimed: 2008-10-02
- Assignees: Dako Denmark A/S
- Applicants: Jørgen Schøller; Henrik Pedersen; Liselotte Brix
- Inventors: Jørgen Schøller; Henrik Pedersen; Liselotte Brix
- Web page: https://patentgrep.com/patent/US10369204B2

## CPC

- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/12: Viral antigens
- A61K 39/21: Retroviridae, e.g. equine infectious anemia virus
- A61K 47/61: the organic macromolecular compound being a polysaccharide or a derivative thereof
- A61K 47/646: {the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines}
- A61P 31/04: Antibacterial agents
- A61P 31/18: for HIV
- C07K 14/70539: {MHC-molecules, e.g. HLA-molecules}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 2039/5154: {Antigen presenting cells [APCs], e.g. dendritic cells or macrophages}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55516: {Proteins; Peptides}
- A61K 2039/55583: {Polysaccharides}
- A61K 2039/6087: {Polysaccharides; Lipopolysaccharides [LPS]}
- A61K 2039/625: {binding through the biotin-streptavidin system or similar}
- C12N 2740/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2740/16234: 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
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to methods for construction of pharmamers i.e. vaccine components characterized by their multimerization domain and the attached biologically active molecules, and their use in preparation of vaccines that contains the pharmamers alone or in combination with other molecules. The individual molecules of the construct can be bound to each other or the multimerization domain(s) by covalent or non-covalent bonds, directly or via linkers. The invention further relates to the use of such preparations in vaccine settings aimed to function as preventive/prophylactic or therapeutic vaccines in humans and animals.

## Claims

### Claim 1

An immunogenic composition for producing an immune response against HIV infection comprising one or more biologically active molecules attached to one or more multimerization domains, which do not include membranes, selected from the group consisting of polymers and solid supports, wherein the one or more biologically active molecules comprise:
i) one or more MHC class I complexes and/or one or more MHC class II complexes attached to the one or more multimerization domains, each optionally loaded with a peptide epitope to form one or more MHC class I-peptide complexes and/or one or more MHC class II-peptide complexes; and, separately,
ii) one or more HIV-derived proteins attached to the one or more multimerization domains, wherein said HIV-derived proteins are each selected from the group consisting of gp41, gp120, gp140, gp27, and recombinant forms thereof.

### Claim 2 (depends on 1)

The immunogenic composition according to claim 1, wherein the one or more biologically active molecules further comprise
iii) one or more immunologically active molecules attached to the one or more multimerization domains.

### Claim 3 (depends on 1)

The immunogenic composition according to claim 1, wherein the one or more multimerization domain(s) comprise a soluble polysaccharide carrier molecule.

### Claim 4 (depends on 1)

The immunogenic composition according to claim 1, wherein the composition further comprises one or more immunological adjuvant(s), wherein said one or more immunological adjuvant(s) are able to enhance or facilitate an immune response.

### Claim 5 (depends on 1)

The immunogenic composition according to claim 1, wherein the composition further comprises one or more living virulent organism(s).

### Claim 6 (depends on 1)

A method for producing an immune response against HIV infection comprising administration to an individual in need thereof an effective amount of the immunogenic composition according to claim 1.

### Claim 7 (depends on 1)

A kit-of-parts comprising the immunogenic composition according to claim 1 and at least one additional component.

### Claim 8 (depends on 7)

A method for vaccination against HIV infection comprising administration to an individual in need thereof an effective amount of the immunogenic composition of the kit of parts according to claim 7.

### Claim 9 (depends on 1)

The immunogenic composition according to claim 1, wherein the one or more HIV-derived proteins selected from the group consisting of gp41, gp 120, gp 140, gp27, and recombinant forms thereof are selected from the group consisting of full length HIV proteins, truncated HIV proteins, and non-truncated but modified HIV proteins.

### Claim 10 (depends on 1)

The immunogenic composition according to claim 1, wherein the one or more HIV-derived proteins are selected from the group consisting of gp140 and gp27, and recombinant forms thereof.

### Claim 11 (depends on 2)

The immunogenic composition according to claim 2, wherein the one or more immunologically active molecules are selected from the group consisting of heat shock proteins, Hsp70, Hsp90, fragments of Hsp70, C-terminal fragments of Hsp70, recombinant HSP70pep3Bio fragment consisting of amino acid residues 359-609 of Hsp70 as shown in SEQ ID NO: 9582, MHC class I proteins, MHC class I-like peptides, MHC class II proteins and MHC class II-like peptides.

### Claim 12 (depends on 1)

The immunogenic composition according to claim 1, wherein the one or more MHC class I complexes and/or the MHC class II complexes further comprise antigenic peptide epitopes derived from HIV proteins selected from the group consisting of HIV-1 proteins and HIV-2 proteins.

### Claim 13 (depends on 1)

The immunogenic composition according to claim 1, wherein the one or more biologically active molecules comprise as component i) one or more human MHC class I complexes and one or more human MHC class II complexes, comprise as component ii) one or more recombinant HIV-1gp 140 trimers comprising three copies of the amino acid sequence shown in SEQ ID NO:9583, and comprise as component iii) one or more heat shock proteins or fragments of heat shock proteins; and wherein each said component is attached to a multimerization domain comprising a soluble polysaccharide carrier molecule.

### Claim 14 (depends on 1)

The immunogenic composition according to claim 1, wherein the one or more biologically active molecules comprise as component i) one or more human MHC class I complexes and one or more human MHC class II complexes, comprise as component ii) one or more recombinant HIV-1gp 140 trimers comprising three copies of the amino acid sequence shown in SEQ ID NO:9583 and one or more SIVp27 comprising the amino acid sequence shown in SEQ ID NO:9584), and comprise as component iii) one or more recombinant HSP70pep3Bio fragments comprising the amino acid sequence shown in SEQ ID NO 9582; and one or more MHC II-like peptides; wherein each said component is attached by biotin-streptavidin binding to a Dextran 270 multimerization domain, wherein the Dextran 270 has a molecular weight of about 270 kDa.

### Claim 15 (depends on 2)

The immunogenic composition according to claim 2, wherein the one or more immunologically active molecules comprise a fragment of Hsp70.

### Claim 16 (depends on 15)

The immunogenic composition according to claim 15, wherein the fragment of Hsp70 is a C-terminal fragment or a recombinant Hsp70pep3Bio fragment consisting of amino acid residues 359-609 of Hsp70 as shown in SEQ ID NO:9582.

### Claim 17 (depends on 1)

The immunogenic composition according to claim 1, wherein the one or more HIV-derived proteins are recombinant trimers comprising three copies of an HIV-derived protein selected from the group consisting of gp41, gp 120, gp 140, gp27, and recombinant forms thereof.

### Claim 18 (depends on 1)

The immunogenic composition according to claim 1, wherein the composition prevents HIV infection or decreases viral load when administered to a subject prior to exposure to HIV.