# US 2014/0193428 A1 · Human cytomegalovirus neutralizing antibodies and use thereof

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- Number: US 2014/0193428 A1
- Document ID: US20140193428A1
- Status: Published application
- Kind: A1
- Application number: 14/096,283
- Filed: 2013-12-04
- Published: 2014-07-10
- Earliest claimed: 2008-07-16
- Assignees: Institute for Research in Biomedicine
- Applicants: Institute for Research In Biomedicine
- Inventors: Antonio LANZAVECCHIA; Annalisa MACAGNO
- Web page: https://patentgrep.com/patent/US20140193428A1

## CPC

- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A01D 34/71: with means for discharging mown material (A01D57/26 - A01D57/30 take precedence; combined with means for gathering or loading mown material A01D43/06)
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/42: viral
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- A61P 31/20: for DNA viruses
- A61P 31/22: for herpes viruses
- C07K 14/005: from viruses
- C07K 16/089: {Cytomegalovirus}
- A01D 34/63: having cutters rotating about a vertical axis
- A01D 2101/00: Lawn-mowers
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- C07K 2317/21: from primates, e.g. man
- 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 2317/41: Glycosylation, sialylation, or fucosylation
- C07K 2317/54: F(ab')2
- C07K 2317/55: Fab or Fab'
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- 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 2710/16122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- 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)
- A01D: HARVESTING; MOWING
- 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)
- 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 relates to neutralizing antibodies, and antibody fragments thereof, having high potency in neutralizing hCMV, wherein said antibodies and antibody fragments are specific for one, or a combination of two or more, hCMV gene UL products. The invention also relates to immortalized B cells that produce, and to epitopes that bind to, such antibodies and antibody fragments. In addition, the invention relates to the use of the antibodies, antibody fragments, and epitopes in screening methods as well as in the diagnosis, prevention, and therapy of disease.

## Claims

### Claim at position 1

1-53. (canceled)

### Claim 54

An isolated antibody, or an antigen binding fragment thereof, comprising the CDR1, CDR2, and CDR3 sequences of the heavy and light chain variable region sequences set forth in SEQ ID NOs: 348 and 349, respectively.

### Claim 55

An isolated antibody, or an antigen binding fragment thereof, comprising heavy and light chain variable region CDR1, CDR2, and CDR3 sequences set forth in SEQ ID NOs: 336, 337, and 338, respectively, and SEQ ID NOs: 339, 340, and 341, respectively.

### Claim 56 (depends on 54)

The antibody or fragment of claim 54, comprising heavy and light chain variable region sequences set forth in SEQ ID NOs: 348 and 349, respectively.

### Claim 57

(canceled)

### Claim 58

An isolated antibody, or antigen binding fragment thereof, comprising heavy and light chain variable region sequences having at least 90% identity to the sequences set forth in SEQ ID NOs: 348 and 349, respectively.

### Claim 59 (depends on 54)

The antibody or fragment of claim 54, that is specific for human cytomegalovirus (hCMV) protein gB.

### Claim 60 (depends on 54)

The antibody or fragment of claim 54, which inhibits infection of epithelial cells, wherein the concentration of antibody required for 90% neutralisation of hCMV is 10 μg/ml or less.

### Claim 61 (depends on 60)

The antibody or fragment of claim 60, wherein the concentration of antibody required for 90% neutralisation of hCMV is 1.2 μg/ml or less.

### Claim 62 (depends on 54)

The antibody or fragment of claim 54, wherein the antibody is a human antibody, a monoclonal antibody, a single chain antibody, Fab, Fab′, F(ab′)2, Fv or scFv.

### Claim 63 (depends on 54)

A composition comprising the antibody or fragment of claim 54, and a diluent or carrier.

### Claim 64 (depends on 63)

The composition of claim 63, further comprising a second antibody, or an antigen binding fragment thereof, which inhibits hCMV infection.

### Claim 65

(canceled)

### Claim 66 (depends on 54)

A method of inhibiting hCMV infection in a subject, comprising administering an effective amount of the antibody or fragment of claim 54, wherein hCMV infection is inhibited.

### Claim 67 (depends on 66)

The method of claim 66, further comprising the step of administering a second antibody, or an antigen binding fragment thereof, which inhibits hCMV infection, wherein the antibodies or fragments are administered simultaneously or sequentially.

### Claim 68 (depends on 54)

A method of inhibiting hCMV infection in a cell, comprising contacting the cell with the antibody of claim 54, wherein hCMV infection is inhibited.

### Claim 69 (depends on 63)

A method of inhibiting hCMV infection in a subject, comprising administering an effective amount of the composition of claim 63, wherein hCMV infection is inhibited.

### Claim 70 (depends on 64)

A method of inhibiting hCMV infection in a subject, comprising administering an effective amount of the composition of claim 64, wherein hCMV infection is inhibited.

### Claim 71

(canceled)