# US 10,501,505 B2 · Polymer particles and uses thereof

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- Number: US 10,501,505 B2
- Document ID: US10501505B2
- Status: Granted
- Kind: B2
- Application number: 15/116,338
- Filed: 2015-02-04
- Published: 2017-01-12
- Granted: 2019-12-10
- Earliest claimed: 2014-02-04
- Applicants: Bernd Helmut Adam Rehm; Bryce Malcolm Buddle; David Neil Wedlock
- Inventors: Bernd Helmut Adam Rehm; Bryce Malcolm Buddle; David Neil Wedlock
- Web page: https://patentgrep.com/patent/US10501505B2

## CPC

- C07K 14/35: from Mycobacteriaceae (F)
- A61K 38/44: Oxidoreductases (1)
- A61K 38/45: Transferases (2)
- A61K 38/51: Lyases (4)
- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61K 49/0006: {Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity}
- A61P 31/06: for tuberculosis
- C12N 9/1025: {Acyltransferases (2.3)}
- G01N 33/6866: {Interferon}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- C07K 2319/00: Fusion polypeptide
- G01N 2333/35: from Mycobacteriaceae (F)
- G01N 2333/57: IFN-gamma
- G01N 2800/26: Infectious diseases, e.g. generalised sepsis
- 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)
- 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)

## Abstract

The present invention relates to polymer particles and uses thereof. In particular the present invention relates to functionalized polymer particles, processes of production and uses thereof in the diagnosis, treatment or prevention of tuberculosis.

## Claims

### Claim 1

A method of diagnosing tuberculosis in a subject, the method comprising administering to the subject an effective amount of at least one polymer particle comprising one or more fusion polypeptides, wherein one or more of the fusion polypeptides comprise a particle-forming protein and three or more selected from the group consisting of:
a. an ESAT6 antigen;
b. a CFP10 antigen,
c. an Rv3615c antigen,
d. an Rv3020c antigen, and
e. an Rv2346c antigen,
and detecting an immune response in the subject, wherein the presence of an immune response is indicative of tuberculosis.

### Claim 2 (depends on 1)

The method of claim 1, wherein the method is a method of detecting M. tuberculosis or M. bovis in a subject.

### Claim 3 (depends on 1)

The method of claim 1, wherein the administration is topical.

### Claim 4 (depends on 1)

The method of claim 1, wherein the administration is by skin prick.

### Claim 5 (depends on 1)

The method of claim 1, wherein the administration is of a diagnostic reagent, and the diagnostic reagent comprises less than 5 μg of each antigen present per dose.

### Claim 6 (depends on 5)

The method of claim 5, wherein the diagnostic reagent comprises less than 5 μg total antigen per dose.

### Claim 7 (depends on 5)

The method of claim 5, wherein the diagnostic reagent comprises less than 1 μg of each antigen present per dose.

### Claim 8

A method of detecting M. tuberculosis or M. bovis in a subject, the method comprising:
providing a sample from a subject,
contacting the sample with at least one polymer particle comprising one or more fusion polypeptides, wherein one or more of the fusion polypeptides comprise a particle-forming protein and three or more selected from the group consisting of:
a. an ESAT6 antigen;
b. a CFP10 antigen,
c. an Rv3615c antigen,
d. an Rv3020c antigen, and
e. an Rv2346c antigen, and
detecting a response indicative of exposure of the subject to one or more M. tuberculosis or M. bovis antigens,
wherein the response is indicative of M. tuberculosis or M. bovis in the subject.

### Claim 9 (depends on 8)

The method of claim 8, wherein the detection of the response is the detection of interferon-gamma.

### Claim 10 (depends on 8)

The method of claim 8, wherein the detection is by a cell proliferation assay, a cell sorting assay, fluorescence-activated cell sorting (FACS), an in situ hybridisation assay, an immunoassay, an enzyme-linked immunosorbent assay (ELISA), a radioimmunoassay, a Western Blot, or a cytokine assay.