Human anti-IL-23 antibodies, compositions, methods and uses

• US 7,935,344 B2
• Filed: 12/28/2006
• Issued: 05/03/2011
• Est. Priority Date: 12/29/2005
• Status: Active Grant

• Current Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Original Assignee: Centocor Ortho Biotech Incorporated (Johnson & Johnson)
• Inventors: Carton, Jill, Rauchenberger, Robert, Cunningham, Mark, Orlovsky, Yevgeniya I., Benson, Jacqueline, Sweet, Raymond
• Primary Examiner(s): SKELDING, ZACHARY S
• Application Number:
  US11/617,503
• Publication Number:
  US 20070218064A1
• Time in Patent Office: 1,587 Days
• Field of Search: None
• US Class Current: 424/145.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• 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 17/08 Antiseborrheics
• 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 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 Immunomodulators
• 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 2317/21 : from primates, e.g. man
• 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 2317/52 : Constant or Fc region; Isotype
• CPC Class Codes: C07K 2317/55 : Fab or Fab'
• CPC Class Codes: C07K 2317/565 : Complementarity determining region [CDR]
• CPC Class Codes: C07K 2317/73 : Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
• 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 2319/00 : Fusion polypeptide
• CPC Class Codes: C07K 2319/30 : Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

A human anti-IL-23p19 antibody, including isolated nucleic acids that encode at least one anti-IL-23p19 antibody, vectors, host cells, 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, comprising a light chain variable region and a heavy chain variable region, said light chain variable region comprising:

a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO;

50;

a CDRL2 amino acid sequence of SEQ ID NO;

56; and

a CDRL3 amino acid sequence of SEQ ID NO;

73,

said heavy chain variable region comprising;

a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO;

5;

a CDRH2 amino acid sequence of SEQ ID NO;

20; and

a CDRH3 amino acid sequence of SEQ ID NO;

44.

2. The isolated IL-23p19 antibody of claim 1, further comprising at least one human framework region adjacent to a complementarity determining region.

8. An IL-23p19 antibody according to any of claims 1, 2, 3-5, 6 and 7 wherein said antibody binds IL-23p19 with at least one affinity selected from at least 10 M, at least 10⁻

10 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.

9. An IL-23p19 antibody according to any of claims 1, 2, 3-5, 6 and 7, wherein said antibody substantially modulates an activity of the IL-23 polypeptide, the activity selected from the group consisting of binding to the IL-23 receptor (IL-23R), induction of STAT3 phosphorylation, and IL-17 production.

10. A composition comprising the isolated IL-23p19 antibody according to claim 9 and at least one pharmaceutically acceptable carrier or diluent.

11. The composition according to claim 10, further comprising at least one compound or polypeptide selected from, 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 ophthalmic drug, an otic drug or nasal drug, a topical drug, a nutritional drug, and a cytokine antagonist.

12. An article of manufacture for human pharmaceutical or diagnostic use, comprising packaging material and a container comprising a solution or a lyophilized form of an IL-23p19 antibody according to any of claims 1, 2, 3-5, 6 and 7.

13. The article of manufacture of claim 12, 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.

23. The composition according to claim 10, wherein the antibody is conjugated to a detectable label or reporter.

3. An isolated IL-23p19 antibody, comprising a light chain variable region comprising the amino acid sequence of SEQ ID NO:

116.

4. An isolated IL-23p19 antibody, comprising a heavy chain variable region comprising e amino acid sequence of SEQ ID NO:

105.

5. An isolated IL-23p19 antibody, comprising a light chain variable region comprising the amino acid sequence of SEQ ID NO:

116 and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO;

105.

6. An isolated IL-23p19 antibody, comprising a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:

105 having up to three substitutions from residues 50-66 of the amino acid sequence of SEQ ID NO;

105.

7. An isolated IL-23p19 antibody, comprising a light chain variable region comprising the amino acid sequence of SEQ ID NO:

116 and the heavy chain variable region of claim 6.

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

142-144.

16. An isolated IL-23p19 antibody, comprising the light chain variable region sequence of claim 14 and a heavy chain variable region amino acid sequence encoded by the nucleotide sequence selected from the group consisting of SEQ ID NOS:

139-141.

17. The IL-23p19 antibody according to claim 16, 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.

18. The IL-23p19 antibody according to claim 16, wherein said antibody substantially modulates an activity of the IL-23 polypeptide, the activity selected from the group consisting of binding to the IL-23 receptor (IL-23R), induction of STAT3 phosphorylation, and IL-17 production.

19. A composition comprising the isolated IL-23p19 antibody according to claim 16 and at least one pharmaceutically acceptable carrier or diluent.

20. A composition according to claim 19, further comprising at least one compound or polypeptide selected from 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 (G1) tract drug, a hormonal drug, a drug for fluid or electrolyte balance, a hematologic drug, an antineoplastic, an immunomodulation drug, an ophthalmic drug, an otic drug or nasal drug, a topical drug, a nutritional drug, and a cytokine antagonist.

21. 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 according to claim 16.

22. The article of manufacture of claim 21, 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.

24. The composition according to claim 19, wherein the antibody is conjugated to a detectable label or reporter.

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

139-141.