# US 2015/0147331 A1 · Neutralising Antibody Molecules having Specificity for Human IL-17

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- Number: US 2015/0147331 A1
- Document ID: US20150147331A1
- Status: Published application
- Kind: A1
- Application number: 14/489,837
- Filed: 2014-09-18
- Published: 2015-05-28
- Earliest claimed: 2004-11-19
- Assignees: UCB Pharma S.A.
- Applicants: Ucb Pharma S.A.
- Inventors: Ralph Adams; Andrew George Popplewell; Stephen Edward Rapecki; Simon Peter Tickle
- Web page: https://patentgrep.com/patent/US20150147331A1

## CPC

- C07K 16/244: {Interleukins [IL]}
- A61K 47/60: the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 11/06: Antiasthmatics
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/10: Antimycotics
- A61P 31/12: Antivirals
- A61P 33/00: Antiparasitic agents
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 41/00: Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/464: {Igs containing CDR-residues from one specie grafted between FR-residues from another}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/20: characterized by taxonomic origin
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/55: Fab or Fab'
- C07K 2317/565: Complementarity determining region [CDR]
- 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: 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to an antibody molecule having specificity for antigenic determinants of IL-17, therapeutic uses of the antibody molecule and methods for producing said antibody molecule.

## Claims

### Claim 1

(canceled)

### Claim 2

A method of treating an IL-17 mediated pathological condition in a mammal comprising the step of administering to the mammal a therapeutically effective amount of a pharmaceutical composition comprising a neutralising antibody having specificity for human IL-17, wherein a variable domain of a heavy chain comprises at least one CDR having a sequence selected from SEQ ID NO:5 for CDR-H1, SEQ ID NO:6 for CDR-H2, and SEQ ID NO:7 for CDR-H3 and wherein a light chain comprises SEQ ID NO:13.

### Claim 3 (depends on 2)

The method of claim 2, wherein the neutralising antibody comprises a light chain and a heavy chain, wherein a variable domain of the heavy chain comprises SEQ ID NO:5 for CDR-H1, SEQ ID NO:6 for CDR-H2, and SEQ ID NO:7 for CDR-H3, and a variable domain of the light chain comprises SEQ ID NO:8 for CDR-L1, SEQ ID NO:9 for CDR-L2, and SEQ ID NO:10 for CDR-L3 to human IL-17.

### Claim 4 (depends on 2)

The method of claim 2, wherein the neutralising antibody comprises a heavy chain and a light chain, wherein a variable domain of the heavy chain comprises the sequence gH11 (SEQ ID NO:11) and a variable domain of the light chain comprises the sequence gL3 (SEQ ID NO: 13).

### Claim 5 (depends on 2)

The method of claim 2, wherein the neutralising antibody comprises a heavy chain comprising sequence given in SEQ ID NO:16 and a light chain comprising sequence given in SEQ ID NO:18.

### Claim 6 (depends on 2)

The method of claim 2, wherein the neutralising antibody comprises a light chain and a heavy chain wherein the heavy chain comprises SEQ ID NO:11.

### Claim 7 (depends on 2)

The method of claim 2, wherein the neutralising antibody binds to the same epitope as an antibody in which a variable domain of a heavy chain comprises sequence gH11 (SEQ ID NO:11) and a variable domain of a light chain comprises the sequence gL3 (SEQ ID NO: 13).

### Claim 8 (depends on 2)

The method of claim 2, wherein the neutralising antibody binds to a same epitope as an antibody comprising a light chain and a heavy chain, wherein a variable domain of the heavy chain comprises SEQ ID NO:5 for CDR-H1, SEQ ID NO:6 for CDR-H2, and SEQ ID NO:7 for CDR-H3 and wherein a variable domain of the light chain comprises SEQ ID NO:8 for CDRL1, SEQ ID NO:9 for CDR-L2, and SEQ ID NO:10 for CDR-L3 to human IL-17.

### Claim 9 (depends on 2)

The method of claim 2, wherein the neutralising antibody cross-blocks binding of an antibody in which a variable domain of a heavy chain comprises sequence gH11 (SEQ ID NO: 11) and a variable domain of a light chain comprises sequence gL3 (SEQ ID NO: 13) to human IL-17.

### Claim 10 (depends on 2)

The method of claim 2, wherein the neutralising antibody cross-blocks binding of an antibody in which a variable domain of a heavy chain comprises SEQ ID NO:5 for CDR-H1, SEQ ID NO:6 for CDR-H2, and SEQ ID NO:7 for CDR-H3 and wherein a variable domain of a light chain comprises SEQ ID NO:8 for CDRL1, SEQ ID NO:9 for CDR-L2, and SEQ ID NO:10 for CDR-L3 to human IL-17.

### Claim 11 (depends on 2)

The method of claim 2, wherein the neutralising antibody is cross-blocked from binding human IL-17 by the antibody in which the variable domain of the heavy chain comprises the sequence gH11 (SEQ ID NO: 11) and the variable domain of the light chain comprises the sequence gL3 (SEQ ID NO: 13) to human IL-17.

### Claim 12 (depends on 2)

The method of claim 2, wherein the neutralising antibody affinity for human IL-17 is between 100 pM and 400 pM.

### Claim 13 (depends on 2)

The method of claim 2, wherein the neutralising antibody affinity for human IL-17 is less than 500 pM.

### Claim 14 (depends on 2)

The method of claim 2, wherein one or more effector or reporter molecules are attached to the neutralising antibody.

### Claim 15 (depends on 2)

The method of claim 2, wherein the pharmaceutical composition further comprises one or more of a pharmaceutically acceptable excipient, diluent or carrier.

### Claim 16 (depends on 2)

The method of claim 2, wherein the IL-17 mediated pathological condition is associated with an increased level of IL-17.

### Claim 17 (depends on 2)

The method of claim 2, wherein the IL-17 mediated pathological condition is an infection comprising viral, bacterial, fungal or parasitic infection, endotoxic shock associated with infection, arthritis, rheumatoid arthritis, asthma, pelvic inflammatory disease, Alzheimer's disease, Crohn' s disease, inflammatory bowel disease, ulcerative colitis, Peyronie's disease, coeliac disease, gallbladder disease, Pilonidal disease, peritonitis, psoriasis, vasculitis, surgical adhesions, stroke, Type I Diabetes, Lyme arthritis, meningoencephalitis, immune mediated inflammatory disorders of the central and peripheral nervous system such as multiple sclerosis and Guillain-Barr syndrome, other autoimmune disorders, pancreatitis, trauma, surgery, graft-versus-host disease, transplant rejection, cancer comprising solid tumours comprising melanomas, hepatoblastomas, sarcomas, squamous cell carcinomas, transitional cell cancers, ovarian cancers and hematologic malignancies and in particular acute myelogenous leukaemia, chronic myelogenous leukemia, gastric cancer and colon cancer, heart disease comprising ischaemic diseases, wherein the diseases comprise myocardial infarction or atherosclerosis, intravascular coagulation, bone resorption, osteoporosis, periodontitis, hypochlorhydia, pain, rheumatoid arthritis, multiple sclerosis, inflammatory disease, autoimmune disease or cancer.

### Claim 18 (depends on 2)

A kit comprising the pharmaceutical composition of claim 2 and instructions for use.

### Claim 19

A method of treating an IL-17 mediated pathological condition in a mammal comprising the step of administering to the mammal a therapeutically effective amount of a pharmaceutical composition comprising a neutralising antibody having specificity for human IL-17, wherein the neutralising antibody binds to a same epitope as an antibody in which a variable domain of a heavy chain comprises sequence gH11 (SEQ ID NO:11) and a variable domain of a light chain comprises sequence gL3 (SEQ ID NO: 13).