# US 2010/0166772 A1 · ANTIGEN-BINDING PROTEINS TARGETING S. AUREUS ORF0657n

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- Number: US 2010/0166772 A1
- Document ID: US20100166772A1
- Status: Published application
- Kind: A1
- Application number: 12/601,933
- Filed: 2008-05-29
- Published: 2010-07-01
- Earliest claimed: 2007-05-31
- Inventors: Annaliesa S. Anderson; Desmond J. Clark; Zhiqiang An; Fubao Wang; Susan L. Secore; Eberhard Durr; Leslie D. Cope; Tessie McNeely
- Web page: https://patentgrep.com/patent/US20100166772A1

## CPC

- C07K 16/1271: Micrococcaceae (F); Staphylococcaceae (F), e.g. Staphylococcus (G)
- A61P 31/04: Antibacterial agents
- C07K 14/4703: {Inhibitors; Suppressors}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/21: from primates, e.g. man
- 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 2317/77: Internalization into the cell
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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
- 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

The present invention features antigen binding proteins that bind to a region found to have an epitope that can be targeted to provide protection against S. aureus infection. The region is designated herein as the “CS-D7” target region. The CS-D7 target region provides an S. aureus ORF0657n epitope that can be targeted to reduce the likelihood or severity of an S. aureus infection.

## Claims

### Claim 1

An isolated antigen binding protein comprising a first variable region and a second variable region, wherein said first and second variable region binds to a CS-D7 target region.

### Claim 2 (depends on 1)

The binding protein of claim 1, wherein said first variable region is a heavy chain variable (Vh) region comprising at least one complementarity determining region (CDR) selected from the group consisting of:
a first Vh CDR comprising SEQ ID NO: 46 or a sequence differing from SEQ ID NO: 46 by one amino acid;
a second Vh CDR comprising either SEQ ID NO: 36, SEQ ID NO: 38, SEQ ID NO: 39,
SEQ ID NO: 41, SEQ ID NO: 43 or SEQ ID NO: 44, or a sequence differing from SEQ ID NOs: 36, 38, 39, 41, 43, or 44 by one amino acid; and,
a third Vh CDR comprising either SEQ ID NO: 37, SEQ ID NO: 42 or SEQ ID NO: 45, or a sequence differing from SEQ ID NOs: 37, 42, or 45 by one amino acid.

### Claim 3 (depends on 2)

The binding protein of claim 2, wherein said Vh region comprises said first Vh CDR, said second Vh CDR and said third Vh CDR.

### Claim 4 (depends on 3)

The binding protein of claim 3, wherein said first, second and third Vh CDRs, respectively, comprise the amino acid sequences selected from the group consisting of:
a) SEQ ID NO: 35, SEQ ID NO: 36 and SEQ ID NO: 37;
b) SEQ ID NO: 35, SEQ ID NO: 38 and SEQ ID NO: 37;
c) SEQ ID NO: 35, SEQ ID NO: 39 and SEQ ID NO: 37;
d) SEQ ID NO: 40, SEQ ID NO: 41 and SEQ ID NO: 42;
e) SEQ ID NO: 40, SEQ ID NO: 43 and SEQ ID NO: 45; and,
f) SEQ ID NO: 40, SEQ ID NO: 44 and SEQ ID NO: 42.

### Claim 5 (depends on 2)

The binding protein of claim 2, wherein said second variable region is a light chain variable (Vl) region comprising at least one complementarity determining region (CDR) selected from the group consisting of:
a first Vl CDR comprising either SEQ ID NO: 17, SEQ ID NO: 20, SEQ ID NO: 23, SEQ ID NO: 26, SEQ ID NO: 29 or SEQ ID NO: 32, or a sequence differing from SEQ ID NOs: 17, 20, 23, 26, 29, or 32 by one amino acid;
a second Vl CDR comprising either SEQ ID NO: 18, SEQ ID NO: 21, SEQ ID NO: 24, SEQ ID NO: 27, SEQ ID NO: 30 or SEQ ID NO: 33, or a sequence differing from SEQ ID NOs: 18, 21, 24, 27, 30 or 33 by one amino acid; and,
a third Vl CDR comprising either SEQ ID NO: 19, SEQ ID NO: 22, SEQ ID NO: 25,
SEQ ID NO: 28, SEQ ID NO: 31 or SEQ ID NO: 34, or a sequence differing from SEQ ID NOs: 19, 22, 25, 28, 31, or 34 by one amino acid.

### Claim 6 (depends on 5)

The binding protein of claim 5, wherein said Vl region comprises said first Vl CDR, said second Vl CDR and said third Vl CDR.

### Claim 7 (depends on 6)

The binding protein of claim 6, wherein said first, second and third Vl CDRs, respectively, comprise the amino acid sequences selected from the group consisting of:
a) SEQ ID NO: 17, SEQ ID NO: 18 and SEQ ID NO: 19;
b) SEQ ID NO: 20, SEQ ID NO: 21 and SEQ ID NO: 22;
c) SEQ ID NO: 23, SEQ ID NO: 24 and SEQ ID NO: 25;
d) SEQ ID NO: 26, SEQ ID NO: 27 and SEQ ID NO: 28;
e) SEQ ID NO: 29, SEQ ID NO: 30 and SEQ ID NO: 31; and,
f) SEQ ID NO: 32, SEQ ID NO: 33 and SEQ ID NO: 34.

### Claim 8 (depends on 7)

The binding protein of claim 7, wherein said binding protein is an antibody.

### Claim 9 (depends on 8)

The binding protein of claim 8, wherein said first Vh CDR, said second Vh CDR and said third Vh CDR, respectively, comprise SEQ ID NO: 35, SEQ ID NO: 36 and SEQ ID NO: 37; and, said first Vl CDR, said second Vl CDR, and said third Vl CDR, respectively, comprise SEQ ID NO: 17, SEQ ID NO: 18 and SEQ ID NO: 19.

### Claim 10 (depends on 8)

The binding protein of claim 8, wherein said Vh region comprises an amino acid sequence selected from the group consisting of amino acids 1-126 of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10, SEQ ID NO: 12, SEQ ID NO: 14 and SEQ ID NO: 16.

### Claim 11 (depends on 10)

The binding protein of claim 10, wherein said Vl region comprises an amino acid sequence selected from the group consisting of amino acids 1-108 of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 5, SEQ ID NO: 7, SEQ ID NO: 9, SEQ ID NO: 11, SEQ ID NO: 13 and SEQ ID NO: 15.

### Claim 12 (depends on 8)

The binding protein of claim 8, wherein said antibody comprises either:
a) a Vl region comprising amino acids 1-108 of SEQ ID NO: 1 and a Vh region comprising amino acids 1-126 SEQ ID NO: 2;
b) a Vl region comprising SEQ ID NO: 3 and a Vh region comprising SEQ ID NO: 4;
c) a Vl region comprising SEQ ID NO: 5 and a Vh region comprising SEQ ID NO: 6;
d) a Vl region comprising SEQ ID NO: 7 and a Vh region comprising SEQ ID NO: 8;
e) a Vl region comprising SEQ ID NO: 9 and a Vh region comprising SEQ ID NO: 10;
f) a Vl region comprising SEQ ID NO: 11 and a Vh region comprising SEQ ID NO: 12;
g) a Vl region comprising SEQ ID NO: 13 and a Vh region comprising SEQ ID NO: 14;
Or,
h) Vl region comprising SEQ ID NO: 15 and a Vh region comprising SEQ ID NO: 16.

### Claim 13 (depends on 12)

The binding protein of claim 12, wherein said Vh region comprises amino acids 1-126 of SEQ ID NO: 2 and said Vl region comprises amino acids 1-108 of SEQ ID NO: 1.

### Claim 14 (depends on 8)

The binding protein of claim 8, wherein said antibody comprises a heavy chain comprising a hinge, CH1, CH2, and CH3 regions from an IgG1, IgG2, IgG3 or IgG4 subtype; and a light chain comprising said Vl region, and either a human kappa Cl or human lambda Cl.

### Claim 15 (depends on 1)

The binding protein of claim 1, wherein said binding protein is an antibody comprising a light chain which comprises SEQ ID NO: 1 and a heavy chain which comprises SEQ ID NO: 2.

### Claim 16 (depends on 5)

A nucleic acid comprising at least one recombinant gene that encodes an antigen binding protein heavy chain variable (Vh) region or an antigen binding protein light chain variable (Vl) region as described in claim 5.

### Claim 17 (depends on 16)

A nucleic acid of claim 16, wherein said nucleic acid comprises two recombinant genes, a first recombinant gene encoding the antigen binding protein Vh region and a second recombinant gene encoding the antigen binding protein Vl region.

### Claim 18 (depends on 17)

A recombinant cell comprising the recombinant nucleic acid of claim 17.

### Claim 19 (depends on 18)

A method of producing a protein comprising an antibody variable region comprising the steps of:
a) growing the recombinant cell of claim 18 under conditions wherein said protein is expressed; and,
b) purifying said protein.

### Claim 20 (depends on 1)

A pharmaceutical composition comprising the binding protein of claim 1 and a pharmaceutically acceptable carrier.

### Claim 21 (depends on 1)

A method of protecting or treating against an S. aureus infection in a patient comprising the step of administering to said patient an effective amount of the binding protein of claim 1.

### Claim 22 (depends on 21)

The method of claim 21, wherein said patient is a human and said antigen binding protein is administered in conjunction with surgery or a foreign body implant.

### Claim 23 (depends on 21)

The method of claim 21, wherein said patient is a human infected with S. aureus.

### Claim 24

(canceled)

### Claim 25

A polypeptide comprising an amino acid sequence with at least a 95% sequence identity to amino acids 42-342 of SEQ ID NO: 47, wherein said polypeptide is up to 350 amino acids in length.