# US 11,992,520 B2 · Human monoclonal antibodies to Staphylococcal aureus Isd proteins and uses thereof

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- Number: US 11,992,520 B2
- Document ID: US11992520B2
- Status: Granted
- Kind: B2
- Application number: 17/276,361
- Filed: 2019-09-06
- Published: 2022-03-17
- Granted: 2024-05-28
- Earliest claimed: 2018-09-18
- Assignees: Vanderbilt University
- Applicants: Vanderbilt University
- Inventors: James E. Crowe, Jr.; Eric Skaar
- Web page: https://patentgrep.com/patent/US11992520B2

## CPC

- A61K 39/085: Staphylococcus
- C07K 16/1271: Micrococcaceae (F); Staphylococcaceae (F), e.g. Staphylococcus (G)
- A61P 31/04: Antibacterial agents
- G01N 33/56938: {Staphylococcus}
- G01N 33/56944: {Streptococcus}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/575: {humoral response}
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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)
- 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)

## Abstract

The present disclosure is directed to antibodies binding to and inhibiting S. aureus and methods for use thereof.

## Claims

### Claim 1

A method of treating a subject infected with S. aureus, or reducing the likelihood of infection of a subject at risk of contracting S. aureus, comprising delivering to said subject an antibody or antibody fragment having heavy chain CDR1-3 sequences of SEQ ID NOS: 115, 116, and 117 and light chain CDR1-3 sequences of SEQ ID NOS: 178, 179 and 180.

### Claim 2 (depends on 1)

The method of claim 1, the antibody or antibody fragment is encoded by a heavy chain variable coding region comprising SEQ ID NO: 21 and a light chain variable coding region comprising SEQ ID NO: 22.

### Claim 3 (depends on 1)

The method of claim 1, the antibody or antibody fragment is encoded by a heavy chain variable region sequence having 95% identity to SEQ ID NO: 21 and a light chain variable region sequence having 95% identity to SEQ ID NO: 22, but retaining coding sequences for heavy chain CDR1-3 sequences of SEQ ID NOS: 115, 116, and 117 and for light chain CDR1-3 sequences of SEQ ID NOS: 178, 179 and 180.

### Claim 4 (depends on 1)

The method of claim 1, wherein said antibody or antibody fragment is encoded by a heavy chain variable region sequence having 70%, 80%, or 90% identity to SEQ ID NO: 21 and a light chain variable region sequence having 70%, 80%, or 90% identity to SEQ ID NO: 22, but retaining coding sequences for heavy chain CDR1-3 sequences of SEQ ID NOS: 115, 116, and 117 and for light chain CDR1-3 sequences of SEQ ID NOS: 178, 179 and 180.

### Claim 5 (depends on 1)

The method of claim 1, wherein said antibody or antibody fragment comprises a heavy chain variable sequence comprising SEQ ID NO: 63 and a light chain variable chain sequence comprising SEQ ID NO: 64.

### Claim 6 (depends on 1)

The method of claim 1, wherein said antibody or antibody fragment comprises a heavy chain variable region sequence having 70%, 80% or 90% identity to SEQ ID NO: 63 and a light chain variable region sequence having 70%, 80% or 90% identity to SEQ ID NO: 64, but retaining the heavy chain CDR1-3 sequences of SEQ ID NOS: 115, 116, and 117 and the light chain CDR1-3 sequences of SEQ ID NOS: 178, 179 and 180.

### Claim 7 (depends on 1)

The method of claim 1, wherein said antibody or antibody fragment comprises a heavy chain variable region sequence having 95% identity to SEQ ID NO: 63 and a light chain variable region sequence having 95% identity to SEQ ID NO: 64, but retaining the heavy chain CDR1-3 sequences of SEQ ID NOS: 115, 116, and 117 and the light chain CDR1-3 sequences of SEQ ID NOS: 178, 179 and 180.

### Claim 8 (depends on 1)

The method of claim 1, wherein the antibody fragment is a recombinant scFv (single chain fragment variable) antibody, Fab fragment, F(ab′)2 fragment, or Fv fragment.

### Claim 9 (depends on 1)

The method of claim 1, wherein said antibody is an IgG, or a recombinant IgG antibody or antibody fragment comprising an Fc portion mutated to alter FcR interactions, to increase half-life and/or increase therapeutic efficacy, or glycan modified to alter FcR interactions.

### Claim 10 (depends on 1)

The method of claim 1, wherein said antibody is a chimeric antibody or a bispecific antibody.

### Claim 11 (depends on 1)

The method of claim 1, wherein said antibody or antibody fragment is administered prior to infection or after infection.

### Claim 12 (depends on 1)

The method of claim 1, wherein said subject is a pregnant female, a sexually active female, or a female undergoing fertility treatments.

### Claim 13 (depends on 1)

The method of claim 1, wherein delivering comprises antibody or antibody fragment administration, or genetic delivery with an RNA or DNA sequence or vector encoding the antibody or antibody fragment.

### Claim 14 (depends on 1)

The method of claim 1, further comprising treating said subject with a second anti-Isd antigen antibody.

### Claim 15 (depends on 14)

The method of claim 14, wherein the second antibody recognizes IsdB.

### Claim 16 (depends on 9)

The method of claim 9, wherein the mutation to increase half-life and/or increase therapeutic efficacy is a LALA, N297, GASD/ALIE, YTE or LS mutation.

### Claim 17 (depends on 9)

The method of claim 9, wherein the glycan modification to alter FcR interactions is as enzymatic or chemical addition or removal of glycans or expression in a cell line engineered with a defined glycosylating pattern.

### Claim 18 (depends on 14)

The method of claim 14, wherein the second antibody recognizes IsdH.