# US 7,608,277 B2 · Tuberculosis nucleic acids, polypeptides and immunogenic compositions

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- Number: US 7,608,277 B2
- Document ID: US7608277B2
- Status: Granted
- Kind: B2
- Application number: 11/291,616
- Filed: 2005-11-30
- Published: 2006-06-29
- Granted: 2009-10-27
- Earliest claimed: 2004-12-01
- Assignees: Gene Therapy Systems, Inc.
- Inventors: David Roth; Huaping He
- Web page: https://patentgrep.com/patent/US7608277B2

## CPC

- G01N 33/5695: {Mycobacteria}
- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61P 37/04: Immunostimulants
- C07K 14/35: from Mycobacteriaceae (F)
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 2039/53: {DNA (RNA) vaccination}
- G01N 2469/20: Detection of antibodies in sample from host which are directed against antigens from microorganisms
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- 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)

## Abstract

The present invention provides transcriptionally active Mtb polynucleotides, recombinant Mtb peptides and polypeptides, and immunogenic Mtb antigens. Immunogenic compositions are also provided that may be useful as recombinant, subunit and DNA vaccines. In addition, the invention provides diagnostic kits for Mtb.

## Claims

### Claim 1

An isolated Mtb peptide or polypeptide selected from the group consisting of SEQ ID NOS: 68, 70, 73, 74, 75, 77, 78, 83, 122, 123, 124, 125, 126, 128, 129, 130, 132, and 133, or an immunogenic fragment thereof.

### Claim 2 (depends on 1)

The peptide or polypeptide of claim 1, wherein said peptide or polypeptide reacts with polyclonal antibodies directed to Mtb bacteria.

### Claim 3 (depends on 1)

The peptide or polypeptide of claim 1, wherein said peptide or polypeptide is detected by either ELISA or Western blotting.

### Claim 4

A recombinant Mtb peptide or polypeptide, wherein the amino terminus of said peptide or polypeptide comprises a HA tag or a His tag, and the carboxy terminus of said peptide or polypeptide is selected from the group consisting of: SEQ ID NOS: 68, 70, 73, 74, 75, 77, 78, 83, 122 123, 124, 125, 126, 128, 129, 130, 132, and 133.

### Claim 5

A recombinant Mtb peptide or polypeptide, wherein the carboxy terminus of said peptide or polypeptide comprises a HA tag or a His tag, and the amino terminus of said peptide or polypeptide is selected from the group consisting of SEQ ID NOS: 68, 70, 73, 74, 75, 77, 78, 83, 122, 123, 124, 125, 126, 128, 129, 130, 132 and 133.

### Claim 6

A composition comprising at least one isolated Mtb peptide or polypeptide selected from the group consisting of: SEQ ID NOS: 68, 70, 73, 74, 75, 77, 78, 83, 122, 123, 124, 125, 126, 128, 129, 130, 132, and 133, or an immunogenic fragment thereof, and a pharmaceuticallv acceptable carrier.

### Claim 7 (depends on 6)

The composition of claim 6, further comprising an adjuvant.

### Claim 8 (depends on 1)

A method of generating an immune response in a mammalian host against Mtb comprising administering to said mammalian host at least one peptide, polypeptide or immunogenic fragment thereof of claim 1 or any combination thereof, whereby said immune response against Mtb is generated.

### Claim 9 (depends on 8)

The method according to claim 8, further comprising administering an adjuvant to said mammalian host.

### Claim 10 (depends on 1)

A kit comprising:
a) at least one peptide or polypeptide of claim 1; and
b) an adjuvant.

### Claim 11 (depends on 10)

The kit of claim 10 comprising at least two of said polypeptides or peptides.

### Claim 12 (depends on 6)

The composition of claim 6, wherein said peptide or polypeptide or immunogenic fragment thereof is a native protein.

### Claim 13 (depends on 6)

The composition of claim 6, wherein said peptide or polypeptide or immunogenic fragment thereof is conjugated to a molecule.

### Claim 14 (depends on 13)

The composition of claim 13, wherein said molecule is a polysaccharide.

### Claim 15 (depends on 6)

The composition of claim 6, wherein said peptide or polypeptide is part of a complex of multiple polypeptide chains.

### Claim 16 (depends on 6)

The composition of claim 6, wherein said peptide or polypeptide reacts with polyclonal antibodies directed to Mtb bacteria.

### Claim 17 (depends on 6)

The composition of claim 6, wherein said Mtb peptide or polypeptide further comprises a tag, wherein said tag is at the amino terminus or carboxy terminus of said Mtb polypeptide.

### Claim 18 (depends on 17)

The composition of claim 17, wherein said tag is a His tag or an HA tag.

### Claim 19 (depends on 6)

A kit comprising:
a) at least one composition of claim 6; and
b) an adjuvant.

### Claim 20 (depends on 19)

The kit of claim 19, comprising at least two of said immunogenic compositions.

### Claim 21 (depends on 6)

A method of generating an immune response in a mammalian host against Mtb comprising administering to said mammalian host at least one composition of claim 6, or combination thereof, whereby said immune response against Mtb is generated.
