# US 2017/0283484 A1 · Anti-hepatitis c antibodies and antigen binding fragments thereof

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- Number: US 2017/0283484 A1
- Document ID: US20170283484A1
- Status: Published application
- Kind: A1
- Application number: 15/507,676
- Filed: 2015-09-04
- Published: 2017-10-05
- Earliest claimed: 2014-09-05
- Assignees: Medical Research Council
- Applicants: Medical Research Council
- Inventors: Arvind PATEL; Ania OWSIANKA
- Web page: https://patentgrep.com/patent/US20170283484A1

## CPC

- C07K 16/118: Hepatitis C virus; GB virus C [GBV-C]
- A61K 39/42: viral
- A61P 31/14: for RNA viruses
- C07K 16/4216: {against anti-viral Ig}
- C12Q 1/707: {non-A, non-B Hepatitis, excluding hepatitis D}
- G01N 33/5767: {non-A, non-B hepatitis}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 2039/505: {comprising antibodies}
- C07K 2319/02: containing a signal sequence
- C07K 2319/40: containing a tag for immunodetection, or an epitope for immunisation
- C12N 2770/24222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- 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
- 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
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The invention provides an antibody or antigen binding fragment thereof capable of binding to the antigen binding pocket of the AP33 antibody, wherein said antibody or antigen binding fragment thereof comprises VL CDR1 (L1), VL CDR2 (L2), and VL CDR3 (L3) consisting of the amino acid sequences of SEQ ID NO:1, SEQ ID NO:2 and SEQ ID NO:23 respectively, and comprises VH CDR1 (H1), VH CDR2 (H2), and VH CDR3 (H3) consisting of the amino acid sequences of SEQ ID NO:24, SEQ ID NO:25, and SEQ ID NO:26 respectively. The invention also provides compositions, methods, nucleic acids and uses.

## Claims

### Claim 1

An antibody or antigen binding fragment thereof capable of binding to the antigen binding pocket of the AP33 antibody, wherein said antibody or antigen binding fragment thereof comprises VL CDR1 (L1), VL CDR2 (L2), and VL CDR3 (L3) consisting of the amino acid sequences of SEQ ID NO: 1, SEQ ID NO:2 and SEQ ID NO:23 respectively, and comprises VH CDR1 (H1), VH CDR2 (H2), and VH CDR3 (H3) consisting of the amino acid sequences of SEQ ID NO:24, SEQ ID NO:25, and SEQ ID NO:26 respectively.

### Claim 2 (depends on 1)

The antibody or antigen binding fragment thereof according to claim 1 wherein said antibody or antigen binding fragment thereof comprises VL amino acid sequence consisting of the amino acid sequence of SEQ ID NO:20.

### Claim 3 (depends on 1)

The antibody or antigen binding fragment thereof according to claim 1 wherein said antibody or antigen binding fragment thereof comprises VH amino acid sequence consisting of the amino acid sequence of SEQ ID NO:22.

### Claim 4 (depends on 1)

The antibody or antigen binding fragment thereof according to claim 1 wherein said antibody or antigen binding fragment thereof comprises VL amino acid sequence consisting of the amino acid sequence of SEQ ID NO:20 and wherein said antibody or antigen binding fragment thereof comprises VH amino acid sequence consisting of the amino acid sequence of SEQ ID NO:22.

### Claim 5 (depends on 1)

The antibody or antigen binding fragment thereof according to claim 1, wherein the antigen binding fragment thereof is selected from the group consisting of a Fab fragment, a Fab′ fragment, a F(ab′)2 fragment, a scFv, a Fv, a rIgG, and a diabody.

### Claim 6 (depends on 5)

The antibody or antigen binding fragment thereof according to claim 5 wherein said antigen binding fragment is a scFv and wherein said scFv comprises the amino acid sequence of SEQ ID NO: 11 or SEQ ID NO:12 or SEQ ID NO:13.

### Claim 7 (depends on 1)

A nucleic acid comprising a nucleotide sequence encoding the variable heavy chain domain and/or the variable light chain domain of the antibody or antigen binding fragment according to claim 1 or a complement thereof.

### Claim 8 (depends on 7)

The nucleic acid of claim 7, wherein the nucleic acid comprises one or more nucleotide sequences selected from the group consisting of SEQ ID NO:19 and SEQ ID NO:21.

### Claim 9

(canceled)

### Claim 10 (depends on 7)

A vector comprising the nucleic acid of claim 7, and optionally an expression control sequence operatively linked to the nucleic acid of claim 7.

### Claim 11

(canceled)

### Claim 12 (depends on 10)

A host cell containing the vector of claim 10.

### Claim 13 (depends on 12)

The host cell of claim 12, wherein the cell is a eukaryotic cell, a Chinese Hamster Ovary (CHO) cell or a human embryonic kidney (HEK) cell.

### Claim 14

(canceled)

### Claim 15 (depends on 12)

A method of producing an antibody or antigen binding fragment thereof, comprising incubating a host cell according to claim 12 such that the encoded variable heavy chain domain and/or variable light chain domain is expressed by the cell; recovering the expressed the antibody or antigen binding fragment thereof; and optionally purifying the recovered antibody or antigen binding fragment thereof.

### Claim 16

(canceled)

### Claim 17 (depends on 1)

A composition comprising the antibody or antigen binding fragment thereof according to claim 1 and a pharmaceutically acceptable carrier or excipient and optionally one or both of a carrier protein and an adjuvant.

### Claim 18 (depends on 17)

The A composition according to claim 17, wherein the composition comprises the carrier protein, and the carrier protein is selected from the group consisting of tetanus toxoid and CRM 197 mutant diphtheria toxin.

### Claim 19

(canceled)

### Claim 20 (depends on 17)

The A composition according to claim 17 formulated for use in humans.

### Claim 21 (depends on 1)

The antibody or antigen binding fragment of claim 1, wherein said antibody or antigen binding fragment thereof is capable of inducing in a mammal an immune response against the hepatitis C virus E2 protein.

### Claim 22

(canceled)

### Claim 23 (depends on 1)

The antibody or antigen binding fragment thereof of claim 1, wherein said antibody or antigen binding fragment thereof exhibits binding to AP33 antibody mutants FL32A, NL91A, WL96A, YH33A, YH50A, YH58A, IH95A and YH100A of less than 50% of its binding to the AP33 antibody.

### Claim 24 (depends on 1)

An antibody that binds to an antibody or antigen binding fragment thereof according to claim 1, which is not an AP33 antibody or a fragment thereof.

### Claim 25 (depends on 1, 24)

An antibody according to claim 24 which is obtained by immunisation of a mammal with an antibody or antigen binding fragment thereof according to claim 1.

### Claim 26 (depends on 1, 7, 10, 17, 24)

A method of inducing in a mammal an immune response against the hepatitis C virus E2 protein, the method comprising administering to said mammal an antibody according to claim 1, an antibody according to claim 24, a nucleic acid according to claim 7, a vector according to claim 10, or a composition according to claim 17.

### Claim 27

(canceled)
