# US 11,897,922 B2 · Immunogenic compositions comprising Mycobacterium tuberculosis polypeptides and fusions thereof

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- Number: US 11,897,922 B2
- Document ID: US11897922B2
- Status: Granted
- Kind: B2
- Application number: 17/367,812
- Filed: 2021-07-06
- Published: 2022-01-20
- Granted: 2024-02-13
- Earliest claimed: 2007-04-04
- Assignees: Access To Advanced Health Institute
- Applicants: Access To Advanced Health Institute
- Inventors: Steven G. Reed; Rhea N. Coler; Gregory C. Ireton; Sylvie Bertholet
- Web page: https://patentgrep.com/patent/US11897922B2

## CPC

- C07K 14/35: from Mycobacteriaceae (F)
- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61P 31/04: Antibacterial agents
- A61P 31/06: for tuberculosis
- A61P 37/04: Immunostimulants
- C07K 14/285: from Pasteurellaceae (F), e.g. Haemophilus influenza
- G01N 33/5695: {Mycobacteria}
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- C07K 2319/00: Fusion polypeptide
- G01N 2469/20: Detection of antibodies in sample from host which are directed against antigens from microorganisms
- 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
- 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
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to compositions and fusion proteins containing at least two Mycobacterium sp.) antigens, and polynucleotides encoding such compositions and fusion proteins. The invention also relates to methods for their use in the treatment, prevention and/or diagnosis of tuberculosis infections.

## Claims

### Claim 1

A method for stimulating an immune response comprising administering to a subject an effective amount of a composition comprising two or more Mycobacterium tuberculosis antigens, wherein the two or more antigens comprise the antigen Rv3478 comprising the amino acid sequence set forth in SEQ ID NO: 41, the antigen Rv3619 comprising the amino acid sequence set forth in SEQ ID NO:46, the antigen Rv2389 comprising the amino acid sequence set forth in SEQ ID NO: 21, and the antigen Rv1886 comprising the amino acid sequence set forth in SEQ ID NO: 145 or an antigen comprising an amino acid sequence having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 41, an antigen comprising an amino acid sequence having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 46, an antigen comprising an amino acid sequence having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 21, and an antigen comprising an amino acid sequence having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 145; and wherein the two or more antigens are covalently linked in the form of a fusion polypeptide.

### Claim 2 (depends on 1)

The method of claim 1, wherein the two or more antigens comprise an antigen comprising an amino acid sequence having at least 99% sequence identity to the amino acid sequence set forth in SEQ ID NO: 41 and an antigen comprising an amino acid sequence having at least 99% sequence identity to the amino acid sequence set forth in SEQ ID NO: 46.

### Claim 3 (depends on 1)

The method of claim 1, wherein the two or more antigens are directly linked.

### Claim 4 (depends on 1)

The method of claim 1, wherein the two or more antigens are linked via an amino acid linker.

### Claim 5 (depends on 1)

The method of claim 1, wherein the composition further comprises an immunostimulant.

### Claim 6 (depends on 5)

The method of claim 5, wherein the immunostimulant is selected from the group consisting of glucopyranosyl lipid adjuvant (GLA), adjuvant system-2 (AS-2), monophosphoryl lipid A, 3-de-O-acylated monophosphoryl lipid A, incomplete Freund's adjuvant (IFA), Quillaja saponaria 21 (QS21), cell wall skeleton (CWS), trehalose dicorynomycolate (TDM), aminoalkyl glucosaminide phosphates (AGPs), CpG-containing oligonucleotides, Toll-like receptor agonists, LelF, saponins, saponin mimetics, biological and synthetic lipid A, imiquimod, gardiquimod, resiquimod, polyI:C, and flagellin, or a combination thereof.

### Claim 7 (depends on 6)

The method of claim 6, wherein the immunostimulant is GLA.

### Claim 8 (depends on 1)

The method of claim 1, wherein the two or more antigens further comprise an antigen comprising an amino acid sequence having at least 99% sequence identity to the amino acid sequence set forth in SEQ ID NO: 21.

### Claim 9 (depends on 1)

The method of claim 1, wherein the two or more antigens further comprise an antigen comprising an amino acid sequence having at least 99% sequence identity to the amino acid sequence set forth in SEQ ID NO: 145.

### Claim 10 (depends on 1)

The method of claim 1, wherein the two or more antigens further comprise an antigen comprising an amino acid sequence having at least 99% sequence identity to the amino acid sequence set forth in SEQ ID NO: 21 and an amino acid sequence having at least 99% sequence identity to the amino acid sequence set forth in SEQ ID NO: 145.

### Claim 11 (depends on 1)

The method of claim 1, wherein the fusion polypeptide is ID91 comprising the amino acid sequence set forth in SEQ ID NO: 236 or an amino acid sequence having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 236.

### Claim 12 (depends on 11)

The method of claim 11, wherein the fusion polypeptide comprises an amino acid sequence having at least 99% sequence identity to the amino acid sequence set forth in SEQ ID NO: 236.