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Last Updated: March 29, 2024

Claims for Patent: 9,447,183


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Summary for Patent: 9,447,183
Title:IL-1 binding proteins
Abstract: Proteins that bind IL-1.alpha. and IL-1.beta. are described along with their use in compositions and methods for treating, preventing, and diagnosing IL-1-related disorders and for detecting IL-1.alpha. and IL-1.beta. in cells, tissues, samples, and compositions.
Inventor(s): Wu; Chengbin (Shanghai, CN), Ambrosi; Dominic J. (Shrewsbury, MA), Hsieh; Chung-ming (Newton, MA), Ghayur; Tariq (Holliston, MA)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:14/107,988
Patent Claims:1. A method for reducing human IL-1 activity in a human subject in need thereof, comprising administering to the human subject a binding protein, wherein the binding protein comprises first and second polypeptide chains, wherein said first polypeptide chain comprises a first VD1-(X1)n-VD2-C-(X2)n, wherein: VD1 is a first heavy chain variable domain; VD2 is a second heavy chain variable domain; C is a heavy chain constant domain; X1 is a linker with the proviso that it is not CH1; X2 is an Fc region; and n is independently 0 or 1; and wherein said second polypeptide chain comprises a second VD1-(X1)n-VD2-C-(X2)n, wherein: VD1 is a first light chain variable domain; VD2 is a second light chain variable domain; C is a light chain constant domain; X1 is a linker with the proviso that it is not CH1; X2 does not comprise an Fc region; and n is independently 0 or 1; wherein, in said first polypeptide chain, VD1 comprises the amino acid sequence of SEQ ID NO: 204; and VD2 comprises the amino acid sequence of SEQ ID NO: 213; wherein, in said second polypeptide chain, VD1 comprises the amino acid sequence of SEQ ID NO: 238; and VD2 comprises the amino acid sequence of SEQ ID NO: 216; and wherein the binding protein binds human IL-1.beta. and human IL-la, such that the human IL-1 activity in the human subject is reduced.

2. The method according to claim 1, wherein administering to the subject is by at least one route selected from the group consisting of: parenteral, subcutaneous, intramuscular, intravenous, intra-articular, 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.

3. The method according to claim 1, further comprising administering at least one additional agent.

4. The method according to claim 3, wherein the at least one additional agent is a therapeutic agent.

5. The method according to claim 4, wherein the therapeutic agent comprises at least one selected from the group consisting of: an inhaled steroid; a beta-agonist; a short-acting beta-agonist; a long-acting beta-agonist; an antagonist of a leukotriene; an antagonist of a leukotriene receptor; salmetero/fluticasone; an IgE inhibitor; an anti-IgE antibody; omalizumab; a phosphodiesterase inhibitor; a PDE4 inhibitor; a xanthine; an anticholinergic drug; a mast cell-stabilizing agent; Cromolyn; an IL-4 inhibitor; an IL-5 inhibitor; an eotaxin/CCR3 inhibitor; an antagonist of histamine; an antagonist of histamine receptors including H1, H2, H3, and H4; an antagonists of prostaglandin D; an antagonist of prostaglandin D receptors DP1 and CRTH2; a TNF antagonist; a soluble fragment of a TNF receptor; etanercept; a TNF enzyme antagonist; a TNF converting enzyme (TACE) inhibitor; a muscarinic receptor antagonist; a TGF-beta antagonist; an interferon gamma; a perfenidone; a chemotherapeutic agent, a methotrexate; a leflunomide; a sirolimus (rapamycin) or an analog thereof; CCI-779; a COX2 inhibitor; a cPLA2 inhibitor; a NSAID; an immunomodulator; a p38 inhibitor; a TPL-2 inhibitor; a MK-2 inhibitor; a NFkB inhibitor; budenoside; an epidermal growth factor; a corticosteroid; cyclosporine; sulfasalazine; an aminosalicylate; 6-mercaptopurine; azathioprine; metronidazole; a lipoxygenase inhibitor; mesalamine; olsalazine; balsalazide; an antioxidant; a thromboxane inhibitor; a IL-1 receptor antagonist; an anti-IL-1.beta. antibody; an anti-IL-6 antibody; a growth factor; an elastase inhibitor; a pyridinyl-imidazole compound; an antibody or agonist of TNF, LT, IL-1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-11, IL-12, IL-14, IL-15, IL-16, IL-17, IL-18, IL-19, IL-20, IL-21, IL-22, IL-23, IL-24, IL-25, IL-26, IL-27, IL-28, IL-29, IL-30, IL-31, IL-32, IL-33, EMAP-II, GM-CSF, FGF, or PDGF; an antibody of CD2, CD3, CD4, CD8, CD25, CD28, CD30, CD40, CD45, CD69, CD90 or their ligands; FK506; rapamycin; mycophenolate mofetil; ibuprofen; prednisolone; a phosphodiesterase inhibitor; an adensosine agonist; an antithrombotic agent; a complement inhibitor; an adrenergic agent; an IRAK inhibitor; a NIK inhibitor; an IKK inhibitor; a p38 inhibitor; a MAP kinase inhibitor; an IL-1.beta. converting enzyme inhibitor; a TNF-.alpha. converting enzyme inhibitor; a T-cell signaling inhibitor; a metalloproteinase inhibitor; a 6-mercaptopurine; an angiotensin converting enzyme inhibitor; a soluble cytokine receptor; a soluble p55 TNF receptor; a soluble p75 TNF receptor; sIL-1RI; sIL-1RII; sIL-6R; an anti-inflammatory cytokine; IL-4; IL-10; IL-11; and TGF-.beta..

6. The method according to claim 4, wherein the therapeutic agent comprises at least one selected from the group consisting of: methotrexate; 6-MP; azathioprine sulphasalazine; mesalazine; olsalazine chloroquinine/hydroxychloroquine; pencillamine; aurothiomalate; azathioprine; colchicine; a corticosteroid; a beta-2 adrenoreceptor agonist; a xanthine; cromoglycate; nedocromil; ketotifen; ipratropium and oxitropium; cyclosporin; FK506; rapamycin; mycophenolate mofetil; leflunomide; a NSAID; a corticosteroid; a phosphodiesterase inhibitor; an adensosine agonist; an antithrombotic agent; a complement inhibitor; an adrenergic agent; an agent which interferes with IKK; p38 inhibitor; MAP kinase inhibitors; an IL-1.beta. converting enzyme inhibitor; a TNF-.alpha. converting enzyme (TACE) inhibitor; a T-cell signaling inhibitor; metalloproteinase inhibitors; sulfasalazine; azathioprine; a 6-mercaptopurine; an angiotensin converting enzyme inhibitor; a soluble cytokine receptor or derivative thereof; an antiinflammatory cytokine; celecoxib; folic acid; hydroxychloroquine sulfate; etanercept; infliximab; naproxen; valdecoxib; sulfasalazine; methylprednisolone; meloxicam; methylprednisolone acetate; gold sodium thiomalate; aspirin; triamcinolone acetonide; propoxyphene napsylate/apap; folate; nabumetone; diclofenac; piroxicam; etodolac; diclofenac sodium; oxaprozin; oxycodone HCl; hydrocodone bitartrate/apap; diclofenac sodium/misoprostol; fentanyl; anakinra; human recombinant; tramadol HCl; salsalate; sulindac; cyanocobalamin/fa/pyridoxine; acetaminophen; alendronate sodium; prednisolone; morphine sulfate; lidocaine hydrochloride; indomethacin; glucosamine sulf/chondroitin; amitriptyline HCl; sulfadiazine; oxycodone HCl/acetaminophen; olopatadine HCl; misoprostol; naproxen sodium; omeprazole; cyclophosphamide; rituximab; IL-1 TRAP; MRA; CTLA4-IG; IL-18 BP; anti-IL-18; anti-IL15; BIRB-796; SCIO-469; VX-702; AMG-548; VX-740; Roflumilast; IC-485; CDC-801; and Mesopram.

7. A method for reducing human IL-1 activity in a human subject in need thereof, comprising administering to the human subject a binding protein, wherein the binding protein comprises first and second polypeptide chains, wherein said first polypeptide chain comprises a first VD1-(X1)n-VD2-C-(X2)n, wherein: VD1 is a first heavy chain variable domain; VD2 is a second heavy chain variable domain; C is a heavy chain constant domain; X1 is a linker with the proviso that it is not CH1; X2 is an Fc region; and n is independently 0 or 1; and wherein said second polypeptide chain comprises a second VD1-(X1)n-VD2-C-(X2)n, wherein: VD1 is a first light chain variable domain; VD2 is a second light chain variable domain; C is a light chain constant domain; X1 is a linker with the proviso that it is not CH1; X2 does not comprise an Fc region; and n is independently 0 or 1; wherein said first polypeptide chain comprises the amino acid sequence of SEQ ID NO: 212; wherein said second polypeptide chain comprises the amino acid sequence of SEQ ID NO: 215; and wherein the binding protein binds human IL-1.beta. and human IL-la, such that the human IL-1 activity is reduced.

8. The method according to claim 7, wherein administering to the subject is by at least one route selected from the group consisting of: parenteral, subcutaneous, intramuscular, intravenous, intra-articular, 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.

9. The method according to claim 7, further comprising administering at least one additional agent.

10. The method according to claim 9, wherein the at least one additional agent is a therapeutic agent.

11. The method according to claim 10, wherein the therapeutic agent comprises at least one selected from the group consisting of: an inhaled steroid; a beta-agonist; a short-acting beta-agonist; a long-acting beta-agonist; an antagonist of a leukotriene; an antagonist of a leukotriene receptor; salmetero/fluticasone; an IgE inhibitor; an anti-IgE antibody; omalizumab; a phosphodiesterase inhibitor; a PDE4 inhibitor; a xanthine; an anticholinergic drug; a mast cell-stabilizing agent; Cromolyn; an IL-4 inhibitor; an IL-5 inhibitor; an eotaxin/CCR3 inhibitor; an antagonist of histamine; an antagonist of histamine receptors including H1, H2, H3, and H4; an antagonist of prostaglandin D; an antagonist of prostaglandin D receptors DP1 and CRTH2; a TNF antagonist; a soluble fragment of a TNF receptor; etanercept; a TNF enzyme antagonist; a TNF converting enzyme (TACE) inhibitor; a muscarinic receptor antagonist; a TGF-beta antagonist; an interferon gamma; a perfenidone; a chemotherapeutic agent, a methotrexate; a leflunomide; a sirolimus (rapamycin) or an analog thereof; CCI-779; a COX2 inhibitor; a cPLA2 inhibitor; a NSAID; an immunomodulator; a p38 inhibitor; a TPL-2 inhibitor; a MK-2 inhibitor; a NFkB inhibitor; budenoside; an epidermal growth factor; a corticosteroid; cyclosporine; sulfasalazine; an aminosalicylate; 6-mercaptopurine; azathioprine; metronidazole; a lipoxygenase inhibitor; mesalamine; olsalazine; balsalazide; an antioxidant; a thromboxane inhibitor; a IL-1 receptor antagonist; an anti-IL-1.beta. antibody; an anti-IL-6 antibody; a growth factor; an elastase inhibitor; a pyridinyl-imidazole compound; an antibody or agonist of TNF, LT, IL-1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-11, IL-12, IL-14, IL-15, IL-16, IL-17, IL-18, IL-19, IL-20, IL-21, IL-22, IL-23, IL-24, IL-25, IL-26, IL-27, IL-28, IL-29, IL-30, IL-31, IL-32, IL-33, EMAP-II, GM-CSF, FGF, or PDGF; an antibody of CD2, CD3, CD4, CD8, CD25, CD28, CD30, CD40, CD45, CD69, CD90 or their ligands; FK506; rapamycin; mycophenolate mofetil; ibuprofen; prednisolone; a phosphodiesterase inhibitor; an adensosine agonist; an antithrombotic agent; a complement inhibitor; an adrenergic agent; an IRAK inhibitor; a NIK inhibitor; an IKK inhibitor; a p38 inhibitor; a MAP kinase inhibitor; an IL-1.beta. converting enzyme inhibitor; a TNF-.alpha. converting enzyme inhibitor; a T-cell signaling inhibitor; a metalloproteinase inhibitor; a 6-mercaptopurine; an angiotensin converting enzyme inhibitor; a soluble cytokine receptor; a soluble p55 TNF receptor; a soluble p75 TNF receptor; sIL-1RI; sIL-1RII; sIL-6R; an anti-inflammatory cytokine; IL-4; IL-10; IL-11; and TGF-.beta..

12. The method according to claim 10, wherein the therapeutic agent comprises at least one selected from the group consisting of: methotrexate; 6-MP; azathioprine sulphasalazine; mesalazine; olsalazine chloroquinine/hydroxychloroquine; pencillamine; aurothiomalate; azathioprine; colchicine; a corticosteroid; a beta-2 adrenoreceptor agonist; a xanthine; cromoglycate; nedocromil; ketotifen; ipratropium and oxitropium; cyclosporin; FK506; rapamycin; mycophenolate mofetil; leflunomide; a NSAID; a corticosteroid; a phosphodiesterase inhibitor; an adensosine agonist; an antithrombotic agent; a complement inhibitor; an adrenergic agent; an agent which interferes with IKK; p38 inhibitor; MAP kinase inhibitors; an IL-10.beta. converting enzyme inhibitor; a TNF-.alpha. converting enzyme (TACE) inhibitor; a T-cell signaling inhibitor; metalloproteinase inhibitors; sulfasalazine; azathioprine; a 6-mercaptopurine; an angiotensin converting enzyme inhibitor; a soluble cytokine receptor or derivative thereof; an antiinflammatory cytokine; celecoxib; folic acid; hydroxychloroquine sulfate; etanercept; infliximab; naproxen; valdecoxib; sulfasalazine; methylprednisolone; meloxicam; methylprednisolone acetate; gold sodium thiomalate; aspirin; triamcinolone acetonide; propoxyphene napsylate/apap; folate; nabumetone; diclofenac; piroxicam; etodolac; diclofenac sodium; oxaprozin; oxycodone HCl; hydrocodone bitartrate/apap; diclofenac sodium/misoprostol; fentanyl; anakinra; human recombinant; tramadol HCl; salsalate; sulindac; cyanocobalamin/fa/pyridoxine; acetaminophen; alendronate sodium; prednisolone; morphine sulfate; lidocaine hydrochloride; indomethacin; glucosamine sulf/chondroitin; amitriptyline HCl; sulfadiazine; oxycodone HCl/acetaminophen; olopatadine HCl; misoprostol; naproxen sodium; omeprazole; cyclophosphamide; rituximab; IL-1 TRAP; MRA; CTLA4-IG; IL-18 BP; anti-IL-18; anti-IL15; BIRB-796; SC10-469; VX-702; AMG-548; VX-740; Roflumilast; IC-485; CDC-801; and Mesopram.

13. The method according to claim 1, wherein said first polypeptide chain comprises the amino acid sequence of SEQ ID NO: 212.

14. The method according to claim 1, wherein said second polypeptide chain comprises the amino acid sequence of SEQ ID NO: 215.

15. The method according to claim 1, wherein said first polypeptide chain comprises the amino acid sequence of SEQ ID NO: 212, and said second polypeptide chain comprises the amino acid sequence of SEQ ID NO: 215.

16. The method of claim 1, wherein the heavy chain constant domain comprises the amino acid sequence of SEQ ID NO: 214; and the light chain constant domain comprises the amino acid sequence of SEQ ID NO: 5.

17. The method of claim 7, wherein the heavy chain constant domain comprises the amino acid sequence of SEQ ID NO: 214; and the light chain constant domain comprises the amino acid sequence of SEQ ID NO: 5.

18. The method of claim 15, wherein the heavy chain constant domain comprises the amino acid sequence of SEQ ID NO: 214; and the light chain constant domain comprises the amino acid sequence of SEQ ID NO: 5.

Details for Patent 9,447,183

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2030-05-14
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 02/19/2002 ⤷  Try a Trial 2030-05-14
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2030-05-14
Immunex Corporation ENBREL etanercept For Injection 103795 11/02/1998 ⤷  Try a Trial 2030-05-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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