IL-23p40 specific immunoglobulin derived proteins, compositions, methods and uses

• US 20050137385A1
• Filed: 05/06/2004
• Published: 06/23/2005
• Est. Priority Date: 05/09/2003
• Status: Active Grant

• Current Assignee: Centocor Incorporated (Johnson & Johnson)
• Original Assignee: Centocor Incorporated (Johnson & Johnson)
• Inventors: Cunningham, Mark, Benson, Jacqueline
• Granted Patent: US 7,247,711 B2
• Time in Patent Office: Days
• US Class Current: 530/388.230
• CPC Class Codes: A61K 2039/505 comprising antibodies
• 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 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• 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 37/02 Immunomodulators
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/244 Interleukins [IL]
• CPC Class Codes: C07K 2317/74 Inducing cell proliferation
• CPC Class Codes: C07K 2317/76 Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Abstract

Novel anti-IL-23p40 specific human Ig derived proteins, including, without limitation, antibodies, fusion proteins, and mimetibodies, isolated nucleic acids that encode the anti-IL-23p40 Ig derived proteins, vectors, host cells, transgenic animals or plants, and methods of making and using thereof, are useful for therapeutic compositions, methods and devices. Preferably, the anti-IL-23p40 specific human Ig derived proteins do not bind the p40 subunit of IL-12 and, thus, do not neutralize IL-12-related activity.

Claims

1. An isolated anti-IL-23p40 Ig derived protein, comprising at least one CDR, wherein said Ig derived protein binds at least one epitope of IL-23p40 and said IL-23p40 derived protein does not bind to the p40 subunit of IL-12.

2. The isolated anti-IL-23p40 Ig derived protein according to claim 1, wherein said Ig derived protein inhibits IL-23 activity in at least one of an antigen presenting cell (APC), lymphocyte, autoreactive T cell, nerve cell, and myelin cell.

3. The isolated anti-IL-23p40 Ig derived protein according to claim 2, wherein said APC or lymphocyte is in a tissue within the central nervous system.

4. The isolated anti-IL-23p40 Ig derived protein according to claim 2, wherein said APC or lymphocyte is in a tissue outside the central nervous system.

5. The isolated anti-IL-23p40 Ig derived protein according to claim 2, wherein said APC is selected from at least one of a macrophage, microglia, Langerhans cell, Kuppfer cell, dendritic cell, B cell, alveolar macrophage, blood monocyte, stem cell precursor, and synovial A cell.

6. The isolated anti-IL-23p40 Ig derived protein according to claim 1, wherein said epitope comprises at least 1-3 amino acids, selected from the group consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 amino acids of at least one of, amino acids 1-10, 10-20, 20-30, 30-40,40-50, 50-60, 60-70, 70-80, 80-90, 90-100, 100-110, 110-120, 120-130, 130-140, 140-150, 150-160, 160-170, 170-180, 180-190, 190-200, 200-210, 210-220, 220-230, 230-240, 240-250, 250-260, 260-270, 280-290, 290-300, 300-306, 1-7, 14-21, 29-52, 56-73, 83-93, 96-105, 156-175, 194-204, 208-246, 254-273, 279-281, and 289-300 of SEQ ID NO:

1.

7. The anti-IL-23p40 Ig derived protein according to claim 1, wherein said Ig derived protein binds IL-23p40 with an affinity of at least one 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.

8. The anti-IL-23p40 Ig derived protein according to claim 1, wherein said Ig derived protein substantially neutralizes at least one activity of an IL-23 protein.

9. An isolated nucleic acid molecule encoding the isolated anti-IL-23p40 Ig derived protein according to claim 1.

10. An isolated nucleic acid vector comprising the isolated nucleic acid molecule according to claim 9.

11. A prokaryotic or eukaryotic host cell comprising the isolated nucleic acid molecule according to claim 9.

12. The host cell according to claim 11, 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, and lymphoma cells, or any derivative, immortalized or transformed cell thereof.

13. A method for producing an anti-IL-23p40 Ig derived protein, comprising translating the nucleic acid molecule according to claim 9 under conditions in vitro, in vivo or in situ, wherein the anti-IL-23p40 Ig derived protein is expressed in detectable or recoverable amounts.

14. A composition comprising the anti-IL-23p40 Ig derived protein according to claim 1 and at least one pharmaceutically acceptable carrier or diluent.

15. The composition according to claim 14, further comprising an effective amount of at least one compound or protein selected from at least one of a detectable label or reporter, an immune therapeutic, 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 antineoplactic, an immunomodulation drug, an opthalmic, otic or nasal drug, a topical drug, a nutritional drug or the like, a TNF antagonist, an antirheumatic, a muscle relaxant, a narcotic, a non-steroid anti-inflammatory drug (NSAID), an analgesic, an anesthetic, a sedative, a local anesthetic, a neuromuscular blocker, an antimicrobial, an antipsoriatic, a corticosteriod, an anabolic steroid, an erythropoietin, an immunization, an immunoglobulin, an immunosuppressive, a growth hormone, a hormone replacement drug, a radiopharmaceutical, an antidepressant, an antipsychotic, a stimulant, an asthma medication, a beta agonist, an inhaled steroid, an epinephrine or analog, a cytokine, and a cytokine antagonist.

16. A method for diagnosing or treating an IL-23p40 related condition in a cell, tissue, organ or animal, comprising:

contacting or administering a composition comprising a modulating effective amount of the anti-IL-23p40 Ig derived protein according to claim 1, with, or to, said cell, tissue, organ or animal.

17. The method according to claim 16, wherein said effective amount is about 0.001-50 mg/kilogram of said cell, tissue, organ or animal.

18. The method according to claim 16, wherein said contacting or administering is 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, bolus, vaginal, rectal, buccal, sublingual, intranasal, or transdermal.

19. The method according to claim 16, further comprising administering, prior, concurrently or after said contacting or administering, at least one selected from an immune therapeutic, a TNF antagonist, an antirheumatic, a muscle relaxant, a narcotic, a non-steroid anti-inflammatory drug (NSAID), an analgesic, an anesthetic, a sedative, a local anesthetic, a neuromuscular blocker, an antimicrobial, an antipsoriatic, a corticosteriod, an anabolic steroid, an IL-23p40 agent, a mineral, a nutritional, a thyroid agent, a vitamin, a calcium related hormone, an antidiarrheal, an antitussive, an antiemetic, an antiulcer, a laxative, an anticoagulant, an erythropoietin, a filgrastim, a sargramostim, an immunization, an immunoglobulin, an immunosuppressive, a growth hormone, a hormone replacement drug, an estrogen receptor modulator, a mydriatic, a cycloplegic, an alkylating agent, an antimetabolite, a mitotic inhibitor, a radiopharmaceutical, an antidepressant, antimanic agent, an antipsychotic, an anxiolytic, a hypnotic, a sympathomimetic, a stimulant, donepezil, tacrine, an asthma medication, a beta agonist, an inhaled steroid, a leukotriene inhibitor, a methylxanthine, a cromolyn, an epinephrine or analog, domase alpha, a cytokine, and a cytokine antagonist.

20. The method according to claim 19, wherein said immune therapeutic is selected from at least one of beta-interferon 1a, beta-interferon 1b, glutiramer acetate, cyclophasphamide, azathioprine, glucocorticosteroids, methotrexate, paclitaxel, 2-chlorodeoxyadenosine, mitoxantrone, an IL-10, TGBbeta, CD4, CD52, antegren, CD11, CD18, TNFalpha, IL-1, IL-2, and/or CD4 antibody or antibody receptor fusion protein, interferon alpha, immunoglobulin, lismide, insulin-like growth factor-1 (IGF-1), elprodil, pirfenidone, and oral myelin.

21. The method according to claim 19, wherein said immune related therapeutic is selected from at least one compound or protein acting on at least one of autoimmune suppression of myelin destruction, immune regulation, activation, proliferation, migration and/or suppressor cell function of T-cells, inhibition of T cell receptor/peptide/MHC-II interaction, Induction of T cell anergy, deletion of autoreactive T cells, reduction of trafficking across the blood brain barrier, alteration of balance of pro-inflammatory (Th1) or immunomodulatory (Th2) cytokines, inhibition of matrix metalloprotease inhibitors, neuroprotection, reduction of gliosis, and promotion of re-myelination.

22. The method according to claim 16, wherein said IL-23p40 related condition is selected from at least one of psoriasis, multiple sclerosis, Crohn'"'"'s disease, psoriatic arthritis, sarcoidosis, Type I diabetes mellitus, systemic lupus erythematosus, and uveitis.

23. A medical device, comprising the anti-IL-23p40 Ig derived protein according to claim 1, wherein said device is suitable to contact or administer said anti-IL-23p40 Ig derived protein 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, bolus, vaginal, rectal, buccal, sublingual, intranasal, and transdermal.

24. An article of manufacture for human pharmaceutical use, comprising packaging material and a container comprising a solution or a lyophilized form of the anti-IL-23p40 Ig derived protein according to claim 1.

25. The article of manufacture of claim 24, 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, bolus, vaginal, rectal, buccal, sublingual, intranasal, or transdermal delivery device or system.

26. A method for producing the anti-IL-23p40 Ig derived protein according to claim 1, comprising providing a host cell, transgenic animal, transgenic plant or plant cell capable of expressing in recoverable amounts said Ig derived protein.

27. An anti-IL-23p40 Ig derived protein produced by the method according to claim 26.

28. An anti-idiotype antibody or fragment specifically binding to the Ig derived protein according to claim 1.

29. An Ig derived protein that competitively inhibits the binding of the Ig derived protein according to claim 1 to a ligand.

30. Any invention described herein.