# US 9,751,931 B2 · Hepatitis C virus neutralizing antibodies and methods

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- Number: US 9,751,931 B2
- Document ID: US9751931B2
- Status: Granted
- Kind: B2
- Application number: 14/437,593
- Filed: 2012-10-26
- Published: 2015-10-15
- Granted: 2017-09-05
- Earliest claimed: 2012-10-26
- Assignees: The United States of America, as represented by the Secretary, Department of Health and Human Services; Federal Budgetary Research Institution State Research Center of Virology and Biotechnology “Vector”
- Applicants: The United States of America, as represented by the Secretary, Department of Health and Human Services; Federal Budgetary Research Institution State Research Center of Virology and Biotechnology “Vector”
- Inventors: Marian Elaine Major; Alla Kachko; Galina Vadimovna Kochneva
- Web page: https://patentgrep.com/patent/US9751931B2

## CPC

- C07K 16/118: Hepatitis C virus; GB virus C [GBV-C]
- A61K 39/29: Hepatitis virus
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- C07K 14/005: from viruses
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- G01N 33/5767: {non-A, non-B hepatitis}
- A61K 2039/5256: {expressing foreign proteins}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- 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 2317/565: Complementarity determining region [CDR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C12N 2770/24222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2770/24234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12Q 1/04: Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor {(C12Q1/6897 takes precedence)}
- 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)
- 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)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

Novel epitope regions on hepatitis C virus E1E2 glycoprotein that induce a neutralizing antibody response in vivo are identified. Cross-neutralizing monoclonal antibodies that bind specifically to the epitopes are disclosed.

## Claims

### Claim 1

An isolated antibody, which binds specifically to an epitope of hepatitis C virus (HCV),
wherein the epitope is contained within amino acid residues 496-515 of the HCV polyprotein set forth in SEQ ID NO:1,
the antibody comprising
a heavy chain variable region comprising complementary determining region (CDR) 1 amino acid sequence of residues 27-34 (GFTFSSFG) of SEQ ID NO:3, CDR2 amino acid sequence of residues 52-59 (ISSGSSTL) of SEQ ID NO:3, and CDR3 amino acid sequence of residues 98-105 (DHGHRLLK) of SEQ ID NO:3, and
a light chain variable region comprising CDR1 amino acid sequence of residues 27-32 (QDVGTA) of SEQ ID NO:5, CDR2 amino acid sequence of residues 50-52 (WAS) of SEQ ID NO:5, and CDR3 amino acid sequence of residues 89-97 (QQYSNFPLT) of SEQ ID NO:5.

### Claim 2 (depends on 1)

The isolated antibody of claim 1, wherein the epitope is amino acid residues 504-507 of SEQ ID NO:1.

### Claim 3 (depends on 1)

The isolated antibody of claim 1, wherein the antibody is a monoclonal antibody, a polyclonal antibody, a chimeric antibody, a humanized antibody, a synthetic antibody, or an antigen-binding antibody fragment.

### Claim 4 (depends on 1)

The isolated antibody of claim 1 that is a humanized antibody.

### Claim 5 (depends on 1)

The isolated antibody of claim 1, comprising a heavy chain variable region comprising an amino acid sequence consisting of SEQ ID NO:3 or encoded by a polynucleotide comprising SEQ ID NO:2.

### Claim 6 (depends on 1)

The isolated antibody of claim 1, comprising a light chain variable region comprising an amino acid sequence consisting of SEQ ID NO:5 or encoded by a polynucleotide comprising SEQ ID NO:4.

### Claim 7 (depends on 1)

A composition comprising
the antibody of claim 1; and
a pharmaceutically acceptable carrier, a toxic material, a solid support, a carrier molecule, a chemotherapeutic agent, or a labeling material.

### Claim 8 (depends on 1)

A method of detecting a hepatitis C virus (HCV) epitope in a sample comprising
contacting the antibody of claim 1 with a sample under conditions such that the antibody binds an epitope of hepatitis C virus (HCV); and
detecting the HCV epitope in the sample by detecting antibody bound to the epitope.

### Claim 9 (depends on 1)

A method for treatment of or prophylaxis against Hepatitis C Virus (HCV) infection comprising
administering the antibody according to claim 1 to a subject prior to or after exposure to Hepatitis C Virus (HCV).

### Claim 10 (depends on 9)

The method of claim 9, wherein the subject is a liver transplant patient.

### Claim 11 (depends on 1)

The antibody of claim 1, wherein the antibody is a monoclonal antibody.

### Claim 12 (depends on 1)

The antibody of claim 1, wherein the antibody is a chimeric antibody.

### Claim 13 (depends on 1)

The antibody of claim 1, wherein the antibody is linked to a toxic material, a solid support, a carrier molecule, or a labeling material.