Anti-IL-23 antibodies, compositions, methods and uses

• US 20070009526A1
• Filed: 06/30/2006
• Published: 01/11/2007
• Est. Priority Date: 06/30/2005
• Status: Active Grant

• Current Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Original Assignee: Centocor Ortho Biotech Incorporated (Johnson & Johnson)
• Inventors: Luo, Jinquan, Giles-Komar, Jill, Cunningham, Mark, Duchala, Cynthia, Benson, Jacqueline, Rycyzyn, Michael, Raymond, Sweet
• Granted Patent: US 7,491,391 B2
• Time in Patent Office: Days
• US Class Current: 424/145.100
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/55527 Interleukins
• CPC Class Codes: A61K 2039/55544 Bacterial toxins
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: C07K 16/244 Interleukins [IL]
• CPC Class Codes: C07K 2317/30 characterized by aspects of specificity or valency
• CPC Class Codes: C07K 2317/33 : Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
• CPC Class Codes: C07K 2317/34 : Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
• CPC Class Codes: C07K 2317/56 : variable (Fv) region, i.e. VH and/or VL
• CPC Class Codes: C07K 2317/565 : Complementarity determining region [CDR]
• CPC Class Codes: C07K 2317/76 : Antagonist effect on antigen, e.g. neutralization or inhibition of binding
• CPC Class Codes: C07K 2317/92 : Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
• CPC Class Codes: C07K 2319/55 : containing a fusion with a toxin, e.g. diphteria toxin
• CPC Class Codes: G01N 2333/54 : Interleukins [IL]
• CPC Class Codes: G01N 33/6869 : Interleukin
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

An anti-IL-23p19 antibody, including isolated nucleic acids that encode at least one anti-IL-23p19 antibody, vectors, host cells, transgenic animals or plants, and methods of making and using thereof have applications in diagnostic and/or therapeutic compositions, methods and devices.

Claims

1. An isolated IL-23p19 antibody, wherein said antibody binds to human IL-23p19 or a fragment thereof at one or more of amino acid residues selected from the group consisting of residues 93-102, 93-110, and/or 127-137 of SEQ ID NO:

1.

2. The isolated antibody of claim 1, wherein said antibody binds to human IL-23p19 or a fragment thereof at amino acid residue 94 of SEQ ID NO:

1.

3. The isolated antibody of claim 1, wherein said antibody is selected from the group consisting of chimeric, humanized, engineered, and human.

18. An antibody that competitively binds to IL-23p19 with the isolated IL-23p19 antibody of claim 1.

21. The IL-23p19 antibody of claim 1, wherein said antibody binds IL-23p19 with at least one affinity selected from at least 10⁻

9 M, at least 10<sup>−

10</sup> M, at least 10<sup>−

11</sup> M, and at least 10<sup>−

12</sup> M, at least 10<sup>−

13</sup> M, at least 10<sup>−

14</sup> M, and at least 10<sup>−

15</sup> M, as determined by surface plasmon resonance or the Kinexa method.

22. The antibody of claim 21, wherein said antibody binds IL-23p19 with an affinity between about 3.38×

10<sup>−

10</sup> M and about 4.3×

10<sup>−

11</sup> M, as determined by surface plasmon resonance.

23. The IL-23p19 antibody of claim 21, wherein said antibody substantially modulates at least one activity of at least one IL-23 polypeptide.

24. An isolated nucleic acid molecule encoding the isolated IL-23p19 antibody of claim 21.

30. A composition comprising the isolated IL-23p19 antibody of any of claims 1, 18, 19, or 20 and at least one pharmaceutically acceptable carrier or diluent.

31. A composition of claim 30, further comprising at least one compound or polypeptide selected from a detectable label or reporter, a TNF antagonist, an anti-infective drug, a cardiovascular (CV) system drug, a central nervous system (CNS) drug, an autonomic nervous system (ANS) drug, a respiratory tract drug, a gastrointestinal (GI) tract drug, a hormonal drug, a drug for fluid or electrolyte balance, a hematologic drug, an antineoplastic, an immunomodulation drug, an opthalmic, otic or nasal drug, a topical drug, a nutritional drug, a cytokine, and a cytokine antagonist.

32. An anti-idiotype antibody or fragment that specifically binds the IL-23p19 antibody of claim 18.

33. A method for diagnosing or treating an IL-23 related condition in a cell, tissue, organ or animal, comprising

contacting or administering a composition comprising an effective amount of the antibody according to any of claims 1, 18, 19, or 20, with, or to, said cell, tissue, organ or animal.

34. The method of claim 33, wherein the IL-23 related condition is selected from the group consisting of psoriasis, psoriatic arthritis, Crohn'"'"'s disease, multiple sclerosis, optic neuritis, and clinically isolated syndrome.

35. The method of claim 34, wherein said effective amount is about 0.001-50 mg/kilogram of said cells, tissue, organ or animal.

36. The method of claim 34, wherein said contacting or said administering is by at least one mode selected from parenteral, subcutaneous, intramuscular, intravenous, intraarticular, intrabronchial, intraabdominal, intracapsular, intracartilaginous, intracavitary, intracelial, intracerebellar, intracerebroventricular, intracolic, intracervical, intragastric, intrahepatic, intramyocardial, intraosteal, intrapelvic, intrapericardiac, intraperitoneal, intrapleural, intraprostatic, intrapulmonary, intrarectal, intrarenal, intraretinal, intraspinal, intrasynovial, intrathoracic, intrauterine, intravesical, intralesional, bolus, vaginal, rectal, buccal, sublingual, intranasal, and transdermal.

37. The method of claim 34, further comprising administering, prior, concurrently or after said contacting or administering, at least one composition comprising an effective amount of at least one compound or polypeptide selected from a detectable label or reporter, an anti-infective drug, a cardiovascular (CV) system drug, a central nervous system (CNS) drug, an autonomic nervous system (ANS) drug, a respiratory tract drug, a gastrointestinal (GI) tract drug, a hormonal drug, a drug for fluid or electrolyte balance, a hematologic drug, an antineoplastic, an immunomodulation drug, an ophthalmic, otic or nasal drug, a topical drug, a nutritional drug, a cytokine, and a cytokine antagonist.

38. A medical device, comprising an IL-23p19 antibody according to any of claims 1, 18, 19, or 20, wherein said device is suitable for contacting or administering said IL-23p19 antibody by at least one mode selected from parenteral, subcutaneous, intramuscular, intravenous, intrarticular, intrabronchial, intraabdominal, intracapsular, intracartilaginous, intracavitary, intracelial, intracerebellar, intracerebroventricular, intracolic, intracervical, intragastric, intrahepatic, intramyocardial, intraosteal, intrapelvic, intrapericardiac, intraperitoneal, intrapleural, intraprostatic, intrapulmonary, intrarectal, intrarenal, intraretinal, intraspinal, intrasynovial, intrathoracic, intrauterine, intravesical, intralesional, bolus, vaginal, rectal, buccal, sublingual, intranasal, and transdermal.

39. An article of manufacture for human pharmaceutical or diagnostic use, comprising packaging material and a container comprising a solution or a lyophilized form of the IL-23p19 antibody of claim 38.

40. The article of manufacture of claim 39, wherein said container is a component of a parenteral, subcutaneous, intramuscular, intravenous, intrarticular, intrabronchial, intraabdominal, intracapsular, intracartilaginous, intracavitary, intracelial, intracerebellar, intracerebroventricular, intracolic, intracervical, intragastric, intrahepatic, intramyocardial, intraosteal, intrapelvic, intrapericardiac, intraperitoneal, intrapleural, intraprostatic, intrapulmonary, intrarectal, intrarenal, intraretinal, intraspinal, intrasynovial, intrathoracic, intrauterine, intravesical, intralesional, bolus, vaginal, rectal, buccal, sublingual, intranasal, or transdermal delivery device or system.

41. A method for producing the isolated IL-23p19 antibody of claim 38, comprising providing a host cell or transgenic animal or transgenic plant or plant cell capable of expressing in recoverable amounts said antibody.

42. An IL-23p19 antibody produced by the method of claim 41.

45. An isolated IL-23p19 antibody, comprising a light chain variable region encoded by the polynucleotide of claim 41 and a heavy chain variable amino acid sequence encoded by the nucleotide sequence selected from the group consisting of SEQ ID NOS:

2, 12, 22, and 32.

46. The isolated antibody of claim 45, wherein said antibody is selected from the group consisting of chimeric, humanized, CDR-grafted, and engineered.

4. An isolated IL-23p19 antibody, comprising at least one light chain variable region, said light chain variable region comprising at least one member from the group consisting of:

a complementarity determining region light chain 1 (CDRL1) amino acid sequence selected from the group consisting of SEQ ID NOS;

9, 19, 29, and 39;

a CDRL2 amino acid sequence selected from the group consisting of SEQ ID NOS;

10, 20, 30, and 40; and

a CDRL3 amino acid sequence selected from the group consisting of SEQ ID NOS;

11, 21, 31, and 41.

6. The isolated IL-23p19 antibody of claim 4, further comprising a heavy chain variable region comprising at least one member from the group consisting of:

a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence selected from the group consisting of SEQ ID NOS;

4, 14, 24, and 34;

a CDRH2 amino acid sequence selected from the group consisting of SEQ ID NOS;

5, 15, 25, and 35; and

a CDRH3 amino acid sequence selected from the group consisting of SEQ ID NOS;

6, 16, 26, and 36.

7. The isolated IL-23p19 antibody of claim 6, further comprising at least one human framework region adjacent to the at least one complementarity determining region.

5. An isolated IL-23p19 antibody, comprising at least one heavy chain variable region, said heavy chain variable region comprising at least one member from the group consisting of:

a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence selected from the group consisting of SEQ ID NOS;

4, 14, 24, and 34;

a CDRH2 amino acid sequence selected from the group consisting of SEQ ID NOS;

5, 15, 25, and 35; and

a CDRH3 amino acid sequence selected from the group consisting of SEQ ID NOS;

6, 16, 26, and 36.

8. An isolated IL-23p19 antibody, comprising at least one light chain variable region, said light chain variable region comprising:

a complementarity determining region light chain 1 (CDRL1) amino acid sequence selected from the group consisting of SEQ ID NOS;

9, 19, 29, and 39;

a CDRL2 amino acid sequence selected from the group consisting of SEQ ID NOS;

10, 20, 30, and 40; and

a CDRL3 amino acid sequence selected from the group consisting of SEQ ID NOS;

11, 21, 31, and 41.

10. The isolated antibody of claim 8, further comprising a heavy chain variable region comprising:

a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence selected from the group consisting of SEQ ID NOS;

4, 14, 24, and 34;

a CDRH2 amino acid sequence selected from the group consisting of SEQ ID NOS;

5, 15, 25, and 35; and

a CDRH3 amino acid sequence selected from the group consisting of SEQ ID NOS;

6, 16, 26, and 36.

9. An isolated IL-23p19 antibody, comprising at least one heavy chain variable region, said heavy chain variable region comprising:

a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence selected from the group consisting of SEQ ID NOS;

4, 14, 24, and 34;

a CDRH2 amino acid sequence selected from the group consisting of SEQ ID NOS;

5, 15, 25, and 35; and

a CDRH3 amino acid sequence selected from the group consisting of SEQ ID NOS;

6, 16, 26, and 36.

11. An isolated IL-23p19 antibody, comprising a light chain variable region amino acid sequence selected from the group consisting of SEQ ID NOS:

8, 18, 28, and 38.

13. An isolated IL-23p19 antibody, comprising the light chain variable region of claim 11 and a heavy chain variable amino acid sequence selected from the group consisting of SEQ ID NOS:

3, 13, 23, and 33.

14. The isolated antibody of claim 13, wherein said antibody light or heavy chain variable region is altered, the alteration selected from the group consisting of chimeric, humanized, CDR-grafted, and engineered.

19. An antibody that competitively binds to IL-23p19 with the isolated IL-23p19 antibody of claim 13.

12. An isolated IL-23p19 antibody, comprising a heavy chain variable region amino acid sequence selected from the group consisting of SEQ ID NOS:

3, 13, 23, and 33.

15. An isolated IL-23p19 antibody, comprising a light chain variable amino acid sequence having at least 90% identity to any of the amino acid sequences selected

17. An isolated IL-23p19 antibody, comprising the light chain variable region of claim 15 and a heavy chain variable amino acid sequence having at least 90% identity to any of the amino acid sequences selected from the group consisting of SEQ ID NOS:

3, 13, 23, and 33.

20. An antibody that competitively binds to IL-23p19 with the isolated IL-23p19 antibody of claim 17.

16. An isolated IL-23p19 antibody, comprising a heavy chain variable amino acid sequence having at least 90% identity to any of the amino acid sequences selected from the group consisting of SEQ ID NOS:

3, 13, 23, and 33.

25. An isolated nucleic acid molecule comprising at least one of:

a light chain nucleotide sequence selected from the group consisting of SEQ ID NOS;

7, 17, 27, and 37; and

a heavy chain nucleotide sequence selected from the group consisting of SEQ ID NOS;

2, 12, 22, and 32.

26. An isolated nucleic acid vector comprising the isolated nucleic acid molecule of claim 25.

27. A prokaryotic or eukaryotic host cell comprising the isolated nucleic acid molecule of claim 26.

28. The host cell of claim 27, wherein said host cell is at least one selected from COS-1, COS-7, HEK293, BHK21, CHO, BSC-1, Hep G2, 653, SP2/0, 293, HeLa, myeloma, or lymphoma cells, or any derivative, immortalized or transformed cell thereof.

29. A method for producing at least one IL-23p19 antibody, comprising translating the nucleic acid molecule of claim 25 under conditions in vitro, in vivo or in situ, such that the IL-23p19 antibody is expressed in detectable or recoverable amounts.

43. An isolated IL-23p19 antibody, comprising a light chain variable amino acid sequence encoded by the nucleotide sequence selected from the group consisting of SEQ ID NOS:

7, 17, 27, and 37.

44. An isolated IL-23p19 antibody, comprising a heavy chain variable amino acid sequence encoded by the nucleotide sequence selected from the group consisting of SEQ ID NOS:

2, 12, 22, and 32.

47. An isolated IL-23p19 antibody, comprising a light chain variable region encoding sequence having at least 90% identity to any of the nucleotide sequences selected from the group consisting of SEQ ID NOS:

7, 17, 27, and 37.

49. An isolated IL-23p19 antibody, comprising the light chain variable region encoding sequence of claim 47 and a heavy chain variable region encoding sequence having at least 90% identity to any of the nucleotide sequences selected from the group consisting of SEQ ID NOS:

2, 12, 22, and 32.

50. An antibody that competitively binds to IL-23p19 with the isolated IL-23p19 antibody of claim 49.

51. An isolated nucleic acid molecule encoding the isolated IL-23p19 antibody of claim 50.

52. An isolated nucleic acid vector comprising the isolated nucleic acid molecule of claim 51.

53. A prokaryotic or eukaryotic host cell comprising the isolated nucleic acid molecule of claim 51.

54. The host cell of claim 53, wherein said host cell is at least one selected from COS-1, COS-7, HEK293, BHK21, CHO, BSC-1, Hep G2, 653, SP2/0, 293, HeLa, myeloma, or lymphoma cells, or any derivative, immortalized or transformed cell thereof.

55. A method for producing at least one IL-23p19 antibody, comprising translating the nucleic acid molecule of claim 51 under conditions in vitro, in vivo or in situ, such that the IL-23p19 antibody is expressed in detectable or recoverable amounts.

56. A composition comprising the isolated IL-23p19 antibody of claim 50 and at least one pharmaceutically acceptable carrier or diluent.

57. The composition of claim 56, further comprising at least one compound or polypeptide selected from a detectable label or reporter, a TNF antagonist, an anti-infective drug, a cardiovascular (CV) system drug, a central nervous system (CNS) drug, an autonomic nervous system (ANS) drug, a respiratory tract drug, a gastrointestinal (GI) tract drug, a hormonal drug, a drug for fluid or electrolyte balance, a hematologic drug, an antineoplastic, an immunomodulation drug, an opthalmic, otic or nasal drug, a topical drug, a nutritional drug, a cytokine, and a cytokine antagonist.

58. An anti-idiotype antibody or fragment that specifically binds the IL-23p19 antibody of claim 50.

59. A method for diagnosing or treating an IL-23 related condition in a cell, tissue, organ or animal, comprising contacting or administering a composition comprising an effective amount of the antibody of claim 50, with, or to, said cell, tissue, organ or animal.

60. The method of claim 59, wherein the IL-23 related condition is selected from the group consisting of psoriasis, psoriatic arthritis, Crohn'"'"'s disease, multiple sclerosis, optic neuritis, and clinically isolated syndrome.

61. The method of claim 60, wherein said effective amount is about 0.001-50 mg/kilogram of said cells, tissue, organ or animal.

62. The method of claim 60, wherein said contacting or said administering is by at least one mode selected from parenteral, subcutaneous, intramuscular, intravenous, intraarticular, intrabronchial, intraabdominal, intracapsular, intracartilaginous, intracavitary, intracelial, intracerebellar, intracerebroventricular, intracolic, intracervical, intragastric, intrahepatic, intramyocardial, intraosteal, intrapelvic, intrapericardiac, intraperitoneal, intrapleural, intraprostatic, intrapulmonary, intrarectal, intrarenal, intraretinal, intraspinal, intrasynovial, intrathoracic, intrauterine, intravesical, intralesional, bolus, vaginal, rectal, buccal, sublingual, intranasal, and transdermal.

63. The method of claim 60, further comprising administering, prior, concurrently or after said contacting or administering, at least one composition comprising an effective amount of at least one compound or polypeptide selected from a detectable label or reporter, an anti-infective drug, a cardiovascular (CV) system drug, a central nervous system (CNS) drug, an autonomic nervous system (ANS) drug, a respiratory tract drug, a gastrointestinal (GI) tract drug, a hormonal drug, a drug for fluid or electrolyte balance, a hematologic drug, an antineoplastic, an immunomodulation drug, an ophthalmic, otic or nasal drug, a topical drug, a nutritional drug, a cytokine, and a cytokine antagonist.

64. A medical device, comprising the IL-23p19 antibody of claim 50, wherein said device is suitable for contacting or administering said IL-23p19 antibody by at least one mode selected from parenteral, subcutaneous, intramuscular, intravenous, intrarticular, intrabronchial, intraabdominal, intracapsular, intracartilaginous, intracavitary, intracelial, intracerebellar, intracerebroventricular, intracolic, intracervical, intragastric, intrahepatic, intramyocardial, intraosteal, intrapelvic, intrapericardiac, intraperitoneal, intrapleural, intraprostatic, intrapulmonary, intrarectal, intrarenal, intraretinal, intraspinal, intrasynovial, intrathoracic, intrauterine, intravesical, intralesional, bolus, vaginal, rectal, buccal, sublingual, intranasal, and transdermal.

65. An article of manufacture for human pharmaceutical or diagnostic use, comprising packaging material and a container comprising a solution or a lyophilized form of the IL-23p19 antibody of claim 50.

66. The article of manufacture of claim 64, wherein said container is a component of a parenteral, subcutaneous, intramuscular, intravenous, intrarticular, intrabronchial, intraabdominal, intracapsular, intracartilaginous, intracavitary, intracelial, intracerebellar, intracerebroventricular, intracolic, intracervical, intragastric, intrahepatic, intramyocardial, intraosteal, intrapelvic, intrapericardiac, intraperitoneal, intrapleural, intraprostatic, intrapulmonary, intrarectal, intrarenal, intraretinal, intraspinal, intrasynovial, intrathoracic, intrauterine, intravesical, intralesional, bolus, vaginal, rectal, buccal, sublingual, intranasal, or transdermal delivery device or system.

67. A method for producing the isolated IL-23p19 antibody of claim 50, comprising providing a host cell or transgenic animal or transgenic plant or plant cell capable of expressing in recoverable amounts said antibody.

68. An IL-23p19 antibody produced by the method of claim 67.

48. An isolated IL-23p19 antibody, comprising a heavy chain variable region encoding sequence having at least 90% identity to any of the nucleotide sequences selected from the group consisting of SEQ ID NOS:

2, 12, 22, and 32.

69. Any invention described herein.