# US 8,540,996 B2 · Monoclonal antibodies specific to hemagglutinin and neuraminidase from influenza virus H5-subtype or N1-subtype and uses thereof

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- Number: US 8,540,996 B2
- Document ID: US8540996B2
- Status: Granted
- Kind: B2
- Application number: 13/610,054
- Filed: 2012-09-11
- Published: 2013-01-03
- Granted: 2013-09-24
- Earliest claimed: 2007-09-13
- Assignees: Temasek Life Sciences Laboratory Limited
- Applicants: Hong Liang Qian; Fang He; Hwei-Sing Kwang
- Inventors: Hong Liang Qian; Fang He; Hwei-Sing Kwang
- Web page: https://patentgrep.com/patent/US8540996B2

## CPC

- C07K 16/108: Orthomyxoviridae (F), e.g. influenza virus
- A61P 31/12: Antivirals
- A61P 31/16: for influenza or rhinoviruses
- G01N 33/56983: {Viruses}
- 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
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12N 2760/16111: Influenzavirus A, i.e. influenza A virus
- G01N 2333/11: Orthomyxoviridae, e.g. influenza virus
- 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)
- 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)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Monoclonal antibodies and related binding proteins that bind specifically to the envelope glycoprotein of H5 subtypes or neuraminidase glycoprotein of N1 subtypes of avian influenza virus (AIV) are provided. The monoclonal antibodies and related binding proteins are useful for the detection of H5 and N1 subtypes of AIV, including H5N1 subtypes and provide means for the diagnosis, surveillance and treatment of dangerous viral infections.

## Claims

### Claim 1

A binding protein that binds specifically to a conformational epitope of the hemagglutinin envelope glycoprotein of an H5 subtype of avian influenza virus and that has the immunological binding characteristics of monoclonal antibody 3H11 as produced by hybridoma 3H11 which is deposited with the American Type Culture Collection with Accession Number PTA-9374, wherein the conformational epitope includes amino acid 155 (Gly).

### Claim 2 (depends on 1)

The binding protein 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 binding protein of claim 1 which is a monoclonal antibody.

### Claim 4

Monoclonal antibody 3H11 as produced by hybridoma 3H11 which is deposited with the American Type Culture Collection with Accession Number PTA-9374.

### Claim 5

A method for detecting H5 subtype avian influenza virus in a biological specimen which comprises contacting the specimen with a binding protein that binds specifically to a conformational epitope of the hemagglutinin envelope glycoprotein of an H5 subtype of avian influenza virus, said binding protein having the immunological binding characteristics of monoclonal antibody 3H11 as produced by hybridoma 3H11 which is deposited with the American Type Culture Collection with Accession Number PTA-9374, wherein the conformational epitope includes amino acid 155 (Gly).

### Claim 6 (depends on 5)

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

### Claim 8 (depends on 7)

The method of claim 7 wherein the monoclonal antibody is antibody 3H11 as produced by hybridoma 3H11 which is deposited with the American Type Culture Collection with Accession Number PTA-9374.

### Claim 9 (depends on 5)

The method of claim 5 which comprises contacting the specimen with a second binding protein that specifically binds to the envelope glycoprotein of an H5 subtype of avian influenza virus, wherein the first binding protein is a capture binding protein and the second 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 first and second binding proteins is a monoclonal antibody.

### Claim 11 (depends on 9)

The method of claim 9 wherein the first and second binding proteins are monoclonal antibodies.

### Claim 12 (depends on 9)

The method of claim 9 wherein the first binding protein is immobilized onto a solid surface.

### Claim 13 (depends on 9)

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

### Claim 14

A kit for detecting H5 subtype avian influenza virus in a biological specimen which comprises a binding protein that binds specifically to a conformational epitope of the hemagglutinin envelope glycoprotein of an H5 subtype of avian influenza virus, said binding protein having the immunological binding characteristics of monoclonal antibody 3H11 as produced by hybridoma 3H11 which is deposited with the American Type Culture Collection with Accession Number PTA-9374 wherein the conformational epitope includes amino acid 155 (Gly), together with at least one reagent for the detection of binding of said binding protein to said envelope glycoprotein.

### Claim 15 (depends on 14)

The kit of claim 14 which comprises a second binding protein that specifically binds to the envelope glycoprotein of an H5 subtype of avian influenza virus, wherein the first binding protein is a capture binding protein and the second 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 first and second binding proteins is a monoclonal antibody.

### Claim 17 (depends on 15)

The kit of claim 15 wherein the first and second binding proteins are monoclonal antibodies.

### Claim 18 (depends on 15)

The kit of claim 15 wherein the first binding protein is immobilized onto a solid surface.

### Claim 19 (depends on 15)

The kit of claim 15 wherein the second 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 H5 subtype avian influenza virus which comprises administering to said subject an effective amount of a binding protein that binds specifically to a conformational epitope of the hemagglutinin envelope glycoprotein of an H5 subtype of avian influenza virus and that has the immunological binding characteristics of monoclonal antibody 3H11 as produced by hybridoma 3H11 which is deposited with the American Type Culture Collection with Accession Number PTA-9374, wherein the conformational epitope includes amino acid 155 (Gly).

### Claim 21 (depends on 20)

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

### Claim 22 (depends on 20)

The method of claim 20, wherein the binding protein is a monoclonal antibody.

### Claim 23 (depends on 14)

The kit of claim 14, wherein the binding protein is monoclonal antibody 3H11 as produced by hybridoma 3H11 which is deposited with the American Type Culture Collection with Accession Number PTA-9374.

### Claim 24 (depends on 20)

The method of claim 20, wherein the binding protein is monoclonal antibody 3H11 as produced by hybridoma 3H11 which is deposited with the American Type Culture Collection with Accession Number PTA-9374.