US2004208874A1PendingUtilityA1

Combination therapy with co-stimulatory factors

50
Priority: Dec 30, 2002Filed: Dec 29, 2003Published: Oct 21, 2004
Est. expiryDec 30, 2022(expired)· nominal 20-yr term from priority
Inventors:Sanjay Khare
A61P 31/18A61P 37/02A61P 3/10A61P 9/04A61P 37/00A61P 37/08A61P 35/02A61P 7/00A61P 9/10A61P 37/06A61P 35/04A61P 43/00A61P 35/00A61P 27/16A61P 25/00A61P 3/00A61P 29/00A61P 25/28A61P 25/20A61P 25/16A61P 25/02C07K 16/2818A61P 11/06A61P 1/02A61P 11/00C07K 16/241A61K 39/395A61P 21/02A61P 19/02A61P 19/10A61K 45/06A61P 13/12A61P 15/06A61P 15/08A61P 21/04A61K 38/02A61P 1/18A61K 39/3955A61P 17/06A61P 1/04
50
PatentIndex Score
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Claims

Abstract

Methods for treating an inflammatory or an immune condition are described. Methods for treating an inflammatory or an immune condition with IL-1 inhibitors and an inhibitor of B cell or T cell activation are described. Methods for treating an inflammatory or an immune condition with TNF inhibitors and an inhibitor of B cell or T cell activation are described.

Claims

exact text as granted — not AI-modified
1 . to  15 . (canceled)  
     
     
         16 . A method for treating a TNF-α mediated disease, which comprises administering a therapeutically effective amount of a TNF-α inhibitor and at least one of a B7 inhibitor and a CD28 inhibitor.  
     
     
         17 . The method of  claim 16 , wherein the TNF-α inhibitor is selected from at least one of sTNFR-I linked to an Fc region, sTNFR-II linked to an Fc region, and a fragment of sTNFR-I or sTNFR-II linked to an Fc region.  
     
     
         18 . The method of  claim 16 , wherein the TNF-α inhibitor comprises 30 kD PEG sTNFR-I.  
     
     
         19 . The method of  claim 16 , wherein the TNF-α inhibitor comprises a 2.6 D sTNFR-I fragment.  
     
     
         20 . The method of  claim 19 , wherein the 2.6 D sTNFR-I fragment comprises 30 kD PEG.  
     
     
         21 . The method of  claim 16 , wherein the TNF-α inhibitor comprises sTNFR-II linked to an Fc region.  
     
     
         22 . The method of  claim 16 , wherein the TNF-α inhibitor is selected from at least one of etanercept, infleximab, and D2E7.  
     
     
         23 . The method of  claim 16 , wherein the TNF-α inhibitor comprises the amino acid sequence SEQ ID NO 4.  
     
     
         24 . The method of  claim 16 , wherein the TNF-α inhibitor comprises PEG sTNFR-I.  
     
     
         25 . The method of any one of  claims 16  to  24 , wherein the B7 inhibitor prevents binding of B7 to CD28.  
     
     
         26 . The method of any one of  claims 16  to  24 , wherein the CD28 inhibitor prevents binding of B7 to CD28.  
     
     
         27 . The method of any one of  claims 16  to  24 , wherein the at least one of the B7 inhibitor and the CD28 inhibitor is selected from at least one of CTLA4, CTLA4-Fc, an antagonist CD28 antibody, and an antagonist B7 antibody.  
     
     
         28 . The method of any one of  claims 16  to  24 , wherein the at least one of the B7 inhibitor and the CD28 inhibitor comprises the amino acid sequence of SEQ ID NO 2.  
     
     
         29 . The method of  claim 16 , wherein the TNF-α mediated disease treated is selected from rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, graft rejection, psoriasis, and inflammatory bowel disease.  
     
     
         30 . The method of  claim 16 , wherein the administering is discontinued for at least one day and then resumed.  
     
     
         31 . The method of  claim 30 , wherein the administering is resumed to treat a recurring inflammatory or autoimmune condition.  
     
     
         32 . to  46 . (canceled)  
     
     
         47 . A method for treating an inflammatory or an autoimmune condition, which comprises administering a therapeutically effective amount of a TNF-α inhibitor and at least one of a B7 inhibitor and a CD28 inhibitor.  
     
     
         48 . The method of  claim 47 , wherein the TNF-α inhibitor is selected from at least one of sTNFR-I linked to an Fc region, sTNFR-II linked to an Fc region, and a fragment of sTNFR-I or sTNFR-II linked to an Fc region.  
     
     
         49 . The method of  claim 47 , wherein the TNF-α inhibitor comprises 30 kD PEG sTNFR-I.  
     
     
         50 . The method of  claim 47 , wherein the TNF-α inhibitor comprises a 2.6 D sTNFR-1 fragment.  
     
     
         51 . The method of  claim 50 , wherein the 2.6 D sTNFR-I fragment comprises 30 kD PEG.  
     
     
         52 . The method of  claim 47 , wherein the TNF-α inhibitor comprises sTNFR-II linked to an Fc region.  
     
     
         53 . The method of  claim 47 , wherein the TNF-α inhibitor is selected from at least one of etanercept, infleximab, and D2E7.  
     
     
         54 . The method of  claim 47 , wherein the TNF-α inhibitor comprises the amino acid sequence SEQ ID NO 4.  
     
     
         55 . The method of  claim 47 , wherein the TNF-α inhibitor comprises PEG sTNFR-I.  
     
     
         56 . The method of any one of  claims 47  to  55 , wherein the B7 inhibitor prevents binding of B7 to CD28.  
     
     
         57 . The method of any one of  claims 47  to  55 , wherein the CD28 inhibitor prevents binding of B7 to CD28.  
     
     
         58 . The method of any one of  claims 47  to  55 , wherein the at least one of the B7 inhibitor and the CD28 inhibitor is selected from at least one of CTLA4, CTLA4-Fc, an antagonist CD28 antibody, and an antagonist B7 antibody.  
     
     
         59 . The method of any one of  claims 47  to  55 , wherein the at least one of the B7 inhibitor and the CD28 inhibitor comprises the amino acid sequence of SEQ ID NO 2.  
     
     
         60 . The method of  claim 47 , wherein the condition treated is selected from rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, graft rejection, psoriasis, and inflammatory bowel disease.  
     
     
         61 . The method of  claim 47 , wherein the administering is discontinued for at least one day and then resumed.  
     
     
         62 . The method of  claim 61 , wherein the administering is resumed to treat a recurring inflammatory or autoimmune condition.  
     
     
         63 . to  76 . (canceled)  
     
     
         77 . A method for treating an inflammatory or an autoimmune condition, which comprises administering a therapeutically effective amount of an IL-1 inhibitor, a therapeutically effective amount of a TNF-α inhibitor, and at least one of a B7 inhibitor and a CD28 inhibitor.  
     
     
         78 . The method of  claim 77 , wherein the TNF-α inhibitor comprises at least one of sTNFR-I, sTNFR-II, an sTNFR fragment, and sTNFR-Fc.  
     
     
         79 . The method of  claim 77 , wherein the TNF-α inhibitor comprises 30 kD PEG-sTNFR-I.  
     
     
         80 . The method of  claim 77 , wherein the TNF-α inhibitor comprises a 2.6 D sTNFR-I fragment.  
     
     
         81 . The method of  claim 80 , wherein the 2.6 D sTNFR-I fragment comprises 30 kD PEG.  
     
     
         82 . The method of  claim 77 , wherein the TNF-α inhibitor comprises sTNFR-II linked to an Fc region.  
     
     
         83 . The method of  claim 77 , wherein the TNF-α inhibitor is selected from etanercept, infleximab, and D2E7.  
     
     
         84 . The method of  claim 77 , wherein the condition treated is selected from rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, graft rejection, psoriasis, and inflammatory bowel disease.  
     
     
         85 . The method of  claim 77 , wherein the administering is discontinued for at least one day and then resumed.  
     
     
         86 . The method of  claim 85 , wherein the administering is resumed to treat a recurring inflammatory or autoimmune condition.  
     
     
         87 . to  103 . (canceled)  
     
     
         104 . A method for treating an inflammatory or an autoimmune condition, which comprises administering a therapeutically effective amount of (i) at least one of an AGP3 inhibitor, a BAFFR inhibitor, and a TACI inhibitor, and (ii) an TNF-α inhibitor.  
     
     
         105 . The method of  claim 104 , wherein the TNF-α inhibitor is selected from at least one of sTNFR-I linked to an Fc region, sTNFR-II linked to an Fc region, and a fragment of sTNFR-I or sTNFR-II linked to an Fc region.  
     
     
         106 . The method of  claim 104 , wherein the TNF-α inhibitor comprises 30 kD PEG sTNFR-I.  
     
     
         107 . The method of  claim 104 , wherein the TNF-α inhibitor comprises a 2.6 D sTNFR-I fragment.  
     
     
         108 . The method of  claim 104 , wherein the 2.6 D sTNFR-I fragment comprises 30 kD PEG.  
     
     
         109 . The method of  claim 104 , wherein the TNF-α inhibitor comprises sTNFR-II linked to an Fc region.  
     
     
         110 . The method of  claim 104 , wherein the TNF-α inhibitor is selected from at least one of etanercept, infleximab, and D2E7.  
     
     
         111 . The method of  claim 104 , wherein the TNF-α inhibitor comprises the amino acid sequence SEQ ID NO 4.  
     
     
         112 . The method of  claim 104 , wherein the TNF-α inhibitor comprises PEG sTNFR-I.  
     
     
         113 . The method of any one of  claims 104  to  112 , wherein the AGP3 inhibitor prevents binding of AGP3 to BAFFR and TACI.  
     
     
         114 . The method of any one of  claims 104  to  112 , comprising a BAFFR inhibitor and a TACI inhibitor, wherein the BAFFR inhibitor and the TACI inhibitor prevent binding of AGP3 to BAFFR and TACI.  
     
     
         115 . The method of any one of  claims 104  to  112 , wherein the at least one of the AGP3 inhibitor, the BAFFR inhibitor, and the TACI inhibitor comprises a TACI soluble receptor molecule.  
     
     
         116 . The method of any one of  claims 104  to  112 , wherein the at least one of the AGP3 inhibitor, the BAFFR inhibitor, and the TACI inhibitor comprises a peptide inhibitor of AGP3.  
     
     
         117 . The method of any one of  claims 104  to  112 , wherein the at least one of the AGP3 inhibitor, the BAFFR inhibitor, and the TACI inhibitor comprises an AGP3 peptibody.  
     
     
         118 . The method of any one of  claims 104  to  112 , wherein the at least one of the AGP3 inhibitor, the BAFFR inhibitor, and the TACI inhibitor comprises a protein encoded by SEQ ID NO 1.  
     
     
         119 . The method of  claim 104 , wherein the condition treated is selected from rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, graft rejection, psoriasis, and inflammatory bowel disease.  
     
     
         120 . The method of  claim 104 , wherein the administering is discontinued for at least one day and then resumed.  
     
     
         121 . The method of  claim 120 , wherein the administering is resumed to treat a recurring inflammatory or autoimmune condition.  
     
     
         122 . A method for treating an inflammatory or an autoimmune condition, which comprises administering a therapeutically effective amount of a TNF-α inhibitor and an OX40 ligand inhibitor.  
     
     
         123 . The method of  claim 122 , wherein the TNF-α inhibitor is selected from at least one of sTNFR-I linked to an Fc region, sTNFR-II linked to an Fc region, and a fragment of sTNFR-I or sTNFR-II linked to an Fc region.  
     
     
         124 . The method of  claim 122 , wherein the TNF-α inhibitor comprises 30 kD PEG sTNFR-I.  
     
     
         125 . The method of  claim 122 , wherein the TNF-α inhibitor comprises a 2.6 D sTNFR-I fragment.  
     
     
         126 . The method of  claim 125 , wherein the 2.6 D sTNFR-I fragment comprises 30 kD PEG.  
     
     
         127 . The method of  claim 122 , wherein the TNF-α inhibitor comprises sTNFR-II linked to an Fc region.  
     
     
         128 . The method of  claim 122 , wherein the TNF-α inhibitor is selected from at least one of etanercept, infleximab, and D2E7.  
     
     
         129 . The method of  claim 122 , wherein the TNF-α inhibitor comprises the amino acid sequence SEQ ID NO 4.  
     
     
         130 . The method of  claim 122 , wherein the TNF-α inhibitor comprises PEG sTNFR-1.  
     
     
         131 . The method of any one of  claims 122  to  130 , wherein the OX40 ligand inhibitor is an anti-OX40 ligand antibody.  
     
     
         132 . The method of  claim 122 , wherein the condition treated is selected from rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, graft rejection, psoriasis, and inflammatory bowel disease.  
     
     
         133 . The method of  claim 122 , wherein the administering is discontinued for at least one day and then resumed.  
     
     
         134 . The method of  claim 133 , wherein the administering is resumed to treat a recurring inflammatory or autoimmune condition.  
     
     
         135 . to  152 . (canceled)  
     
     
         153 . A method of treating an TNF mediated disease which comprises administering a therapeutically effective amount of an TNF-α inhibitor and at least one of a B7 inhibitor and a CD28 inhibitor, wherein the TNF-α inhibitor and the at least one of a B7 inhibitor and a CD28 inhibitor are administered in an initial dose given at the start of treatment over a period of 1-10 days and in one or more maintenance doses given over a period of 1-10 days, wherein (a) an interval between the initial dose and the first maintenance dose is greater than about one week, (b) an interval between any two maintenance doses is greater than about one week, or (c) both an interval between the initial dose and the first maintenance dose is greater than about one week and an interval between any two maintenance doses is greater than about one week.  
     
     
         154 . The method of  claim 153  wherein either (a) an interval between the initial dose and the first maintenance dose is greater than about two weeks, (b) an interval between any two maintenance doses is greater than about two weeks, or (c) both an interval between the initial dose and the first maintenance dose is greater than about two weeks and an interval between any two maintenance doses is greater than about two weeks.  
     
     
         155 . The method of  claim 153  wherein either (a) an interval between the initial dose and the first maintenance dose is greater than about one month, (b) an interval between any two maintenance doses is greater than about one month, or (c) both an interval between the initial dose and the first maintenance dose is greater than about one month and an interval between any two maintenance doses is greater than about one month.  
     
     
         156 . The method of  claim 153  wherein either (a) an interval between the initial dose and the first maintenance dose is greater than about two months, (b) an interval between any two maintenance doses is greater than about two months, or (c) both an interval between the initial dose and the first maintenance dose is greater than about two months and an interval between any two maintenance doses is greater than about two months.  
     
     
         157 . The method of  claim 153  wherein either (a) an interval between the initial dose and the first maintenance dose is greater than about three months, (b) an interval between any two maintenance doses is greater than about three months, or (c) both an interval between the initial dose and the first maintenance dose is greater than about three months and an interval between any two maintenance doses is greater than about three months.  
     
     
         158 . The method of  claim 153  wherein the TNF-α inhibitor comprises PEG-sTNFRI 2.6D and the at least one of a B7 inhibitor and a CD28 inhibitor comprises CTLA-4 Fc.  
     
     
         159 . The method of  claim 153  wherein the TNF-α inhibitor comprises etanercept and the at least one of a B7 inhibitor and a CD28 inhibitor comprises CTLA-4 Fc.  
     
     
         160 . to  165 . (canceled)

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