# US 2010/0166754 A1 · Methods and Compositions For Treating Autoimmune Diseases or Conditions

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- Number: US 2010/0166754 A1
- Document ID: US20100166754A1
- Status: Published application
- Kind: A1
- Application number: 12/649,938
- Filed: 2009-12-30
- Published: 2010-07-01
- Earliest claimed: 2003-04-22
- Assignees: Fred Hutchinson Cancer Research Center
- Inventors: Thomas Spies; Veronika Spies
- Web page: https://patentgrep.com/patent/US20100166754A1

## CPC

- C07K 16/2851: {against the lectin superfamily, e.g. CD23, CD72}
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/00: Drugs for immunological or allergic disorders
- G01N 33/577: involving monoclonal antibodies {binding reaction mechanisms characterised by the use of monoclonal antibodies (G01N33/5302 - G01N33/576 take precedence)}
- A61K 2039/505: {comprising antibodies}
- 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 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- G01N 2500/04: Screening involving studying the effect of compounds C directly on molecule A (e.g. C are potential ligands for a receptor A, or potential substrates for an enzyme A)
- G01N 2500/10: involving cells
- 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)
- 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 relates to methods of treating immune disorders, particularly autoimmune and inflammatory disorders such as rheumatoid arthritis, and methods of producing antibodies for use in therapeutic strategies for treating such disorders. Generally, the present methods involve the use of antibodies that specifically bind to NKG2D receptors present on the surface of cells underlying the disorders.

## Claims

### Claim 1

A method of treating a patient with an inflammatory or autoimmune disorder, said method comprising administering to said patient a pharmaceutical composition comprising an inhibitor of an NKG2D receptor, and a pharmaceutically acceptable carrier.

### Claim 2 (depends on 1)

The method of claim 1, wherein said inhibitor is a monoclonal antibody, or a fragment or derivative thereof.

### Claim 3 (depends on 2)

The method of claim 2, wherein said antibody is humanized, chimeric, or human.

### Claim 4 (depends on 2)

The method of claim 2, wherein said antibody is derived from a monoclonal antibody selected from the group consisting of 1D11.

### Claim 5 (depends on 1)

The method of claim 1, wherein said inhibitor interferes with the binding of an NKG2D ligand to the NKG2D receptor.

### Claim 6 (depends on 1)

The method of claim 1, wherein said inflammatory or autoimmune disorder is rheumatoid arthritis.

### Claim 7 (depends on 1)

The method of claim 1, wherein said inflammatory or autoimmune disorder is selected from the group consisting of Wegener's granulomatosis, Sjogren's syndrome, and insulin-dependent diabetes mellitus.

### Claim 8 (depends on 1)

The method of claim 1, wherein said method further comprises the administration of a pharmaceutical composition comprising a therapeutic compound selected from the group consisting of an inhibitor of TNF-alpha and an inhibitor of IL-15.

### Claim 9 (depends on 1)

The method of claim 1, wherein said patient has an elevated level of NKG2D-expressing T cells.

### Claim 10 (depends on 9)

The method of claim 9, wherein said T cells are CD4+.

### Claim 11 (depends on 10)

The method of claim 10, wherein said T cells are CD28−.

### Claim 12 (depends on 1)

The method of claim 1, wherein said method further comprises a diagnostic step in which, prior to the administration of said inhibitor, the prevalence of NKG2D-expressing CD4+CD28− T cells in said patient is assessed, wherein a detection of elevated levels of said cells in said patient indicates that the patient is suitable for the administration of said inhibitor.

### Claim 13 (depends on 12)

The method of claim 12, wherein said diagnostic step comprises an immunoassay to detect the presence of CD4, CD28, or NKG2D on T cells obtained from said patient.

### Claim 14 (depends on 2)

The method of claim 2, wherein said antibody is a cytotoxic antibody.

### Claim 15 (depends on 14)

The method of claim 14, wherein said cytotoxic antibody comprises an element selected from the group consisting of a toxic peptide and a toxic small molecule.

### Claim at position 16

-27. (canceled)