US2014065164A1PendingUtilityA1

Ip-10 antibody dosage escalation regimens

Individually held — no corporate assignee on recordPriority: Apr 29, 2011Filed: Apr 27, 2012Published: Mar 6, 2014
Est. expiryApr 29, 2031(~4.8 yrs left)· nominal 20-yr term from priority
A61P 37/06A61P 29/00C07K 2317/76A61K 39/3955A61P 1/00C07K 16/4208G01N 33/686C07K 2317/90A61P 1/04C07K 2317/21A61K 2039/505C07K 16/24
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Claims

Abstract

In certain embodiments, the present invention provides a method of treating an IP10-related disease in a subject, comprising: (a) administering to the subject a predetermined dosage of an anti-IPIO antibody; (b) detecting the level of the anti-IPIO antibody in a sample of the subject; and (c) if the level of the anti-IPIO antibody from step (b) is below a threshold exposure level, increasing the dosage of the anti-IPIO antibody in the subject such that the IP-10 related disease in the subject is treated.

Claims

exact text as granted — not AI-modified
1 . A method of treating an IP10-related disease in a subject in need of treatment, comprising:
 (a) administering to the subject a predetermined dosage of an anti-IP10 antibody;   (b) detecting the level of the anti-IP10 antibody in a sample of the subject; and   (c) if the level of the anti-IP10 antibody from step (b) is below a threshold exposure level, increasing the dosage of the anti-IP10 antibody in the subject such that the IP-10 related disease in the subject is treated.   
     
     
         2 . (canceled) 
     
     
         3 . The method of  claim 1 , wherein the anti-IP10 antibody is MDX-1100. 
     
     
         4 . The method of  claim 1 , wherein the anti-IP10 antibody comprises:
 (a) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 2; and   (b) a light chain variable region comprising the amino acid sequence of SEQ ID NO: 7.   
     
     
         5 . The method of  claim 4 , wherein the anti-IP10 antibody comprises:
 (a) a heavy chain variable region CDR1 comprising SEQ ID NO: 3;   (b) a heavy chain variable region CDR2 comprising SEQ ID NO: 4;   (c) a heavy chain variable region CDR3 comprising SEQ ID NO: 5;   (d) a light chain variable region CDR1 comprising SEQ ID NO: 8;   (e) a light chain variable region CDR2 comprising SEQ ID NO: 9; and   (f) a light chain variable region CDR3 comprising SEQ ID NO: 10.   
     
     
         6 . The method of  claim 1 , wherein the level of the anti-IP10 antibody in step (b) is detected by a method comprising contacting said sample with an antibody which binds to the anti-IP10 antibody under conditions suitable for antibody-antigen complex formation, followed by the detection of the antibody-antigen complex formation. 
     
     
         7 . The method of  claim 6 , wherein the antibody which binds to the anti-IP10 antibody is an anti-idiotypic antibody. 
     
     
         8 . The method of  claim 6 , wherein the anti-idiotypic antibody binds to one or more CDRs of MDX-1100. 
     
     
         9 . The method of  claim 8 , wherein the anti-idiotypic antibody is selected from 10C8, 6C9, 2F5, and 23H10. 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . The method of  claim 6 , wherein said detection is accomplished by a means selected from the group consisting of EIA, ELISA, RIA, indirect competitive immunoassay, direct competitive immunoassay, non-competitive immunoassay, sandwich immunoassay, and agglutination assay. 
     
     
         13 . The method of  claim 1 , wherein the IP10-related disease is an inflammatory or autoimmune disease. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 13 , wherein the inflammatory or autoimmune disease is an inflammatory bowel disease. 
     
     
         16 . The method of  claim 15 , wherein the inflammatory bowel disease is ulcerative colitis. 
     
     
         17 . The method of  claim 15 , wherein the inflammatory bowel disease is Crohn's disease. 
     
     
         18 . An isolated monoclonal antibody or an antigen binding portion thereof, which specifically binds to an anti-IP10 antibody. 
     
     
         19 . The antibody or an antigen binding portion thereof, of  claim 18 , wherein the antibody is an anti-idiotypic antibody. 
     
     
         20 . The antibody or an antigen binding portion thereof, of  claim 18 , wherein the anti-IP10 antibody is MDX-1100. 
     
     
         21 . The antibody or an antigen binding portion thereof, of  claim 20 , wherein the antibody binds to one or more CDRs of MDX-1100. 
     
     
         22 . The antibody or an antigen binding portion thereof, of  claim 21 , wherein the antibody is selected from 10C8, 6C9, 2F5, and 23H10. 
     
     
         23 . A hybridoma cell line which produces the monoclonal antibody of  claim 18 . 
     
     
         24 . A kit comprising: (1) the antibody, or antigen-binding portion thereof, of  claims 18 ; and (2) reagents necessary for facilitating an antibody-antigen complex formation. 
     
     
         25 . (canceled)

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