# US 8,465,751 B2 · Cna—B domain antigens in vaccines against gram positive bacteria

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- Number: US 8,465,751 B2
- Document ID: US8465751B2
- Status: Granted
- Kind: B2
- Application number: 13/144,149
- Filed: 2010-01-12
- Published: 2012-02-09
- Granted: 2013-06-18
- Earliest claimed: 2009-01-12
- Assignees: Novartis AG
- Applicants: Andrea Guido Oreste Manetti; Immaculada Margarit Y Ros; Guido Grandi
- Inventors: Andrea Guido Oreste Manetti; Immaculada Margarit Y Ros; Guido Grandi
- Web page: https://patentgrep.com/patent/US8465751B2

## CPC

- C07K 14/315: from Streptococcus (G), e.g. Enterococci
- A61K 39/085: Staphylococcus
- A61K 39/092: {Streptococcus}
- A61P 31/04: Antibacterial agents
- A61P 37/04: Immunostimulants
- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- C12N 15/03: Bacteria
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- 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)
- 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)

## Abstract

The invention provides protective antigens which are useful in vaccine compositions to induce protection against gram positive bacteria, particularly against S. agalactiae, S. pyogenes, S. pneumoniae, S. aureus, S. suis, and S. equi.

## Claims

### Claim 1

A Cna_B domain antigen selected from the group consisting of:
(a) a Cna_B domain antigen comprising the amino acid sequence SEQ ID NO:5, wherein amino acid 1 of SEQ ID NO:5 is not linked by a peptide bond to amino acid 311 of SEQ ID NO:21 and/or amino acid 70 of SEQ ID NO:5 is not linked by a peptide bond to amino acid 382 of SEQ ID NO:21;
(b) a Cna_B domain antigen which consists of the amino acid sequence SEQ ID NO:5 and 307, 308, 309, or 310 additional contiguous amino acids of SEQ ID NO:21 at the N terminus of SEQ ID NO:5; and
(c) a Cna_B domain antigen which consists of the amino acid sequence SEQ ID NO:5 and 307, 308, 309, or 310 additional contiguous amino acids of SEQ ID NO:21 at the N terminus of SEQ ID NO:5 and 0-380 additional contiguous amino acids of SEQ ID NO:21 at the C terminus of SEQ ID NO:5, and wherein the Cna B domain antigen is not a native gram positive bacterial protein, SEQ ID NO:21.

### Claim 2 (depends on 1)

The Cna_B domain antigen of claim 1 which consists of the amino acid sequence SEQ ID NO:5.

### Claim 3 (depends on 1)

The Cna_B domain antigen of claim 1 which is coupled to a carrier protein.

### Claim 4 (depends on 1)

The Cna_B domain antigen of claim 1 which is an isolated antigen.

### Claim 5 (depends on 1)

The Can_B domain antigen of claim 1, which comprises the amino acid sequence SEQ ID NO:5, wherein amino acid 1 of SEQ ID NO:5 is not linked by a peptide bond to amino acid 311 of SEQ ID NO:21 and/or amino acid 70 of SEQ ID NO:5 is not linked by a peptide bond to amino acid 382 of SEQ ID NO:21.

### Claim 6 (depends on 1)

The Cna_B domain antigen of claim 1, which consists of the amino acid sequence SEQ ID NO:5 and 307, 308, 309, or 310 additional contiguous amino acids of SEQ ID NO:21 at the N terminus of SEQ ID NO:5.

### Claim 7 (depends on 1)

The Cna_B domain antigen of claim 1, which consists of the amino acid sequence SEQ ID NO:5 and 307, 308, 309, or 310 additional contiguous amino acids of SEQ ID NO:21 at the N terminus of SEQ ID NO:5 and 0-380 additional contiguous amino acids of SEQ ID NO:21 at the C terminus of SEQ ID NO:5.

### Claim 8 (depends on 1)

The Cna_B domain antigen of claim 1, which is a recombinant antigen.

### Claim 9 (depends on 1)

A fusion polypeptide, comprising:
a Cna_B domain antigen of claim 1; and
a bacterial antigen.

### Claim 10 (depends on 9)

The fusion polypeptide of claim 9 which is coupled to a carrier protein.

### Claim 11 (depends on 1)

A composition comprising:
an active agent selected from the group consisting of the Cna_B domain antigen of claim 1; and a fusion polypeptide comprising the Cna_B domain antigen of claim 1; and
a pharmaceutically acceptable carrier.

### Claim 12 (depends on 11)

A kit comprising:
(a) a container comprising the composition of claim 11; and
(b) instructions for using the composition to raise an immune response against a gram positive bacterial protein comprising a Cna_B domain.

### Claim 13 (depends on 1)

A method of raising an immune response against the Cna B domain antigen of claim 1, comprising administering to an individual in need thereof an effective amount of a Cna_B domain antigen of claim 1 or a fusion polypeptide comprising the Cna_B domain antigen of claim 1.

### Claim 14 (depends on 13)

The method of claim 13, wherein the Cna_B domain antigen comprises the amino acid sequence SEQ ID NO:5, wherein amino acid 1 of SEQ ID NO:5 is not linked by a peptide bond to amino acid 311 of SEQ ID NO:21 and/or amino acid 70 of SEQ ID NO:5 is not linked by a peptide bond to amino acid 382 of SEQ ID NO:21.

### Claim 15 (depends on 1, 13)

The method of claim 13, wherein the Cna_B domain antigen of claim 1, which consists of the amino acid sequence SEQ ID NO:5 and 307, 308, 309, or 310 additional contiguous amino acids of SEQ ID NO:21 at the N terminus of SEQ ID NO:5.

### Claim 16 (depends on 1, 13)

The method of claim 13, wherein the Cna_B domain antigen of claim 1, which consists of the amino acid sequence SEQ ID NO:5 and 307, 308, 309, or 310 additional contiguous amino acids of SEQ ID NO:21 at the N terminus of SEQ ID NO:5 and 0-380 additional contiguous amino acids of SEQ ID NO:21 at the C terminus of SEQ ID NO:5.

### Claim 17 (depends on 13)

The method of claim 13, wherein the Cna_B domain antigen consists of the amino acid sequence SEQ ID NO:5.