# US 8,540,995 B2 · Monoclonal antibodies specific to the fusion peptide from hemagglutinin from influenza A viruses and uses thereof

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- Number: US 8,540,995 B2
- Document ID: US8540995B2
- Status: Granted
- Kind: B2
- Application number: 13/141,160
- Filed: 2008-12-24
- Published: 2011-10-20
- Granted: 2013-09-24
- Earliest claimed: 2008-12-24
- Assignees: Temasek Life Sciences Laboratory Limited
- Applicants: Prabakaran Mookkan; Nayana Prabhu Padubidhri; Sumathy Velumani; Hwei-Sing Jimmy Kwang
- Inventors: Prabakaran Mookkan; Nayana Prabhu Padubidhri; Sumathy Velumani; Hwei-Sing Jimmy Kwang
- Web page: https://patentgrep.com/patent/US8540995B2

## CPC

- G01N 33/56983: {Viruses}
- A61P 31/16: for influenza or rhinoviruses
- C07K 16/108: Orthomyxoviridae (F), e.g. influenza virus
- A61K 2039/505: {comprising antibodies}
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- G01N 2333/11: Orthomyxoviridae, e.g. influenza virus
- 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)
- 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)
- 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)

## Abstract

This invention relates to methods and products for the diagnosis, surveillance, prevention, and treatment of influenza A virus infections in animals and humans. More particularly, the invention relates to antibodies and related binding proteins for the detection, prevention and treatment of influenza A viruses. The monoclonal antibodies and related binding proteins of the invention are useful for the treatment of the highly pathogenic H5 subtypes of avian influenza virus (AIV).

## Claims

### Claim 1

An antibody that binds specifically to an epitope of a hemagglutinin of H5 subtype of avian influenza A virus and that has the immunological binding characteristics of monoclonal antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759, wherein said immunological binding characteristics comprise binding to an epitope that is bound by monoclonal antibody 1C9.

### Claim 2 (depends on 1)

The antibody of claim 1 which is a monoclonal antibody, a single chain antibody, an antibody fragment, a chimeric antibody or a humanized antibody.

### Claim 3 (depends on 1)

The antibody of claim 1 which is a monoclonal antibody.

### Claim 4

Monoclonal antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759.

### Claim 5

A method for detecting an influenza A virus in a biological specimen which comprises (a) contacting the specimen with an antibody that binds specifically to an epitope of hemagglutinin of H5 subtype of avian influenza A virus and that has the immunological binding characteristics of monoclonal antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759, wherein said immunological binding characteristics comprise binding to an epitope that is bound by monoclonal antibody 1C9 and (b) detecting the binding of said antibody.

### Claim 6 (depends on 5)

The method of claim 5 wherein the antibody is a monoclonal antibody, a single chain antibody, an antibody fragment, a chimeric antibody or a humanized antibody.

### Claim 7 (depends on 5)

The method of claim 5 wherein the antibody is a monoclonal antibody.

### Claim 8 (depends on 7)

The method of claim 7 wherein the monoclonal antibody is antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759.

### Claim 9 (depends on 5)

The method of claim 5 which further comprises contacting the specimen with a binding protein that specifically binds to an epitope of a glycoprotein of an influenza A virus, wherein said antibody is a capture antibody and the binding protein is a detector binding protein that contains or is conjugated to a detectable element.

### Claim 10 (depends on 9)

The method of claim 9 wherein at least one of the antibody and the binding proteins is a monoclonal antibody.

### Claim 11 (depends on 9)

The method of claim 9 wherein the antibody and the binding protein are monoclonal antibodies.

### Claim 12 (depends on 9)

The method of claim 9 wherein the antibody is immobilized onto a solid surface.

### Claim 13 (depends on 9)

The method of claim 9 wherein the binding protein contains a radioactive atom, is conjugated to a fluorescent molecule, or is conjugated to an enzyme.

### Claim 14

A kit for detecting an influenza A virus in a biological specimen which comprises an antibody that binds specifically to an epitope of hemagglutinin of an H5 subtype of avian influenza A virus and that has the immunological binding characteristics of monoclonal antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759, wherein said immunological binding characteristics comprise binding to an epitope that is bound by monoclonal antibody 1C9 together with reagents for the detection of binding of said antibody to said hemagglutinin.

### Claim 15 (depends on 14)

The kit of claim 14 which further comprises a binding protein that specifically binds to an epitope of a glycoprotein of an influenza A virus, wherein the antibody is a capture antibody and the binding protein is a detector binding protein that contains or is conjugated to a detectable element.

### Claim 16 (depends on 15)

The kit of claim 15 wherein at least one of the antibody and the binding protein is a monoclonal antibody.

### Claim 17 (depends on 15)

The kit of claim 15 wherein the antibody and the second binding protein are monoclonal antibodies.

### Claim 18 (depends on 15)

The kit of claim 15 wherein the antibody is immobilized onto a solid surface.

### Claim 19 (depends on 15)

The kit of claim 15 wherein the binding protein contains a radioactive atom, is conjugated to a fluorescent molecule, or is conjugated to an enzyme.

### Claim 20

A method of treating a subject infected with an influenza A virus which comprises administering to said subject a therapeutically effective amount of an antibody that binds specifically to an epitope of a hemagglutinin of an H5 subtype of avian influenza A virus and that has the immunological binding characteristics of monoclonal antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759, wherein said immunological binding characteristics comprise binding to an epitope that is bound by monoclonal antibody 1C9.

### Claim 21 (depends on 20)

The method of claim 20, wherein the antibody is a recombinant monoclonal antibody, single chain antibody, antibody fragment, chimeric antibody or humanized antibody.

### Claim 22 (depends on 20)

The method of claim 20, wherein the antibody is monoclonal antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759.

### Claim 23 (depends on 20)

The method of claim 20, wherein the influenza A virus that infected the subject is an H5 subtype of avian influenza virus.

### Claim 24 (depends on 23)

The method of claim 23, wherein the avian influenza virus is an H5N1 subtype.

### Claim 25

A method of protecting a subject from an influenza A virus infection comprising administering to said subject an antibody that binds specifically to an epitope of hemagglutinin of an influenza A virus and that has the immunological binding characteristics of monoclonal antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759, wherein said immunological binding characteristics comprise binding to an epitope that is bound by monoclonal antibody 1C9 in an amount effective to protect the subject from influenza A virus infection.

### Claim 26 (depends on 25)

The method of claim 25, wherein the antibody is a recombinant monoclonal antibody, single chain antibody, antibody fragment, chimeric antibody or humanized antibody.

### Claim 27 (depends on 25)

The method of claim 25, wherein the antibody is monoclonal antibody 1C9 as produced by hybridoma 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759.

### Claim 28 (depends on 25)

The method of claim 25, wherein the influenza A virus to protect the subject from is an H5 subtype of avian influenza virus.

### Claim 29 (depends on 28)

The method of claim 28, wherein the avian influenza virus is an H5N1 subtype.