# US 9,751,939 B2 · Anti-GM-CSF antibodies

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- Number: US 9,751,939 B2
- Document ID: US9751939B2
- Status: Granted
- Kind: B2
- Application number: 12/923,363
- Filed: 2010-09-16
- Published: 2011-02-24
- Granted: 2017-09-05
- Earliest claimed: 2005-05-18
- Assignees: Morphosys AG
- Applicants: Stefan Steidl; Elisabeth Thomassen-Wolf
- Inventors: Stefan Steidl; Elisabeth Thomassen-Wolf
- Web page: https://patentgrep.com/patent/US9751939B2

## CPC

- C07K 16/243: {Colony Stimulating Factors}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 11/06: Antiasthmatics
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 25/00: Drugs for disorders of the nervous system
- 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
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61K 2039/505: {comprising antibodies}
- C07K 2317/14: Specific host cells or culture conditions, e.g. components, pH or temperature
- C07K 2317/21: from primates, e.g. man
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/52: Constant or Fc region; Isotype
- 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 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- 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
- C07K 2319/00: Fusion polypeptide
- 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 provides recombinant antigen-binding regions, antibodies and functional fragments thereof that are specific for GM-CSF, which plays an integral role in various disorders or conditions. These antibodies, accordingly, can be used to treat, for example, inflammatory diseases such as rheumatoid arthritis. Antibodies of the invention also can be used in the diagnostics field, as well as for further investigating the role of GM-CSF in the progression of various disorders. The invention also provides nucleic acid sequences encoding the foregoing antibodies, vectors containing the same, pharmaceutical compositions and kits with instructions for use.

## Claims

### Claim 1

An isolated human or humanized antibody or functional fragment thereof that is specific for human GM-CSF, wherein said isolated human or humanized antibody or functional fragment thereof is able
(i) to block interaction of 0.5 μg/ml human GM-CSF with the alpha chain of human GM-CSF receptor expressed on about 2×105 CHO-K1 cells by at least 50% under the following conditions:
(a) the concentration of said human GM-CSF receptor alpha chain expressed on said CHO-K1 cells is similar to the concentration of human GM-CSF receptor alpha chain expressed on about 2×105 CHO-GMRa#11 cells, and
(b) the concentration of said isolated human or humanized antibody or functional fragment thereof is about 5 μg/ml; and
(ii) to neutralize 0.25 ng/ml human GM-CSF in a TF-1 proliferation assay with an at least five-fold lower IC50 value than reference antibodies MAB215 or BVD2-21C11.

### Claim 2 (depends on 1)

An isolated human or humanized antibody according to claim 1, which is an IgG.

### Claim 3 (depends on 1)

A pharmaceutical composition comprising an isolated humanized or human antibody or functional fragment thereof according to claim 1, and a pharmaceutically acceptable carrier or excipient therefor.

### Claim 4 (depends on 1)

The isolated human or humanized antibody or functional fragment thereof of claim 1, wherein said isolated human or humanized antibody or functional fragment thereof is able to neutralize 0.25 ng/ml human GM-CSF in a TF-1 proliferation assay with an at least 10-fold lower IC50 value than the reference antibody MAB215 or BVD2-21C11.

### Claim 5 (depends on 4)

The isolated human or humanized antibody or functional fragment thereof of claim 4, wherein said isolated human or humanized antibody or functional fragment thereof is able to neutralize 0.25 ng/ml human GM-CSF in a TF-1 proliferation assay with an at least 30-fold lower IC50 value than the reference antibody MAB215 or BVD2-21C11.