US2019092849A1PendingUtilityA1

Anti-tnf antibodies, compositions, methods and use for the treatment or prevention of type 1 diabetes

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Assignee: JANSSEN BIOTECH INCPriority: Feb 5, 2016Filed: Feb 2, 2017Published: Mar 28, 2019
Est. expiryFeb 5, 2036(~9.5 yrs left)· nominal 20-yr term from priority
Inventors:Joseph HedrickElizabeth C. HsiaPaul ImmJocelyn LeuBethany PaxsonMark RigbySongmao ZhengRamineh Zoka
C07K 2317/565A61P 29/00A61P 3/10A61K 2039/545A61M 5/003C07K 2317/21A61K 2039/505C07K 16/241A61M 5/31591A61M 5/31573A61M 5/31533
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Claims

Abstract

The present invention relates to compositions and methods utilizing anti-TNF antibodies having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37 for use in the treatment or prevention of Type I Diabetes (T1D).

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 - 101 . (canceled) 
     
     
         102 . At least one isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37 for use in the treatment or prevention of Type I Diabetes. 
     
     
         103 . A method for treating or preventing a TNF related condition, wherein the TNF related condition is Type 1 Diabetes, the method comprising:
 (a) administering to a subject an isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37.   
     
     
         104 . The method according to  claim 103 , wherein said anti-TNF antibody is administered subcutaneaously (SC) to the subject at an induction dose of 60 mg/m 2  at weeks 0 and 2 followed by a maintenance dose of 30 mg/m 2  at week 4 and q2w through week 52 when the subject weighs <45 kg and administered to the subject at an induction dose of 100 mg/m 2  at weeks 0 and 2 followed by a maintenance dose of 50 mg/m 2  at week 4 and q2w through week 52 when the subject weighs ≥45 kg. 
     
     
         105 . The method according to  claim 104 , wherein said anti-TNF antibody is administered with a medical device suitable for self-administration and the device is selected from the group consisting of: prefilled syringe, prefilled syringe with an UltraSafe Passive Needle Guard, VarioJect, and combinations of VarioJect and prefilled syringe with an UltraSafe Passive Needle Guard. 
     
     
         106 . The medical deviced according to  claim 105 , wherein the device is a prefilled syringe with an UltraSafe Passive Needle Guard if the subject weighs ≥45 kg and VarioJect if the subject weighs <45 kg. 
     
     
         107 . The medical deviced according to  claim 105 , wherein the device is a VarioJect with a 4.5 mm needle length. 
     
     
         108 . A composition comprising at least one isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37, and at least one pharmaceutically acceptable carrier or diluent for use in the treatment or prevention of Type I Diabetes. 
     
     
         109 . A method for treating or preventing a TNF related condition, wherein the TNF related condition is Type 1 Diabetes, the method comprising:
 (a) administering to a subject a composition comprising an isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37.   
     
     
         110 . The method according to  claim 109 , wherein said composition is administered subcutaneaously (SC) to the subject such that said anti-TNF antibody is administered at an induction dose of 60 mg/m 2  at weeks 0 and 2 followed by a maintenance dose of 30 mg/m 2  at week 4 and q2w through week 52 when the subject weighs <45 kg and administered to the subject at an induction dose of 100 mg/m 2  at weeks 0 and 2 followed by a maintenance dose of 50 mg/m 2  at week 4 and q2w through week 52 when the subject weighs ≥45 kg. 
     
     
         111 . The method according to  claim 110 , wherein said composition is administered with a medical device suitable for self-administration and the device is selected from the group consisting of: prefilled syringe, prefilled syringe with an UltraSafe Passive Needle Guard, VarioJect, and combinations of VarioJect and prefilled syringe with an UltraSafe Passive Needle Guard. 
     
     
         112 . The medical deviced according to  claim 111 , wherein the device is a prefilled syringe with an UltraSafe Passive Needle Guard if the subject weighs ≥45 kg and VarioJect if the subject weighs <45 kg. 
     
     
         113 . The medical deviced according to  claim 111 , wherein the device is a VarioJect with a 4.5 mm needle length. 
     
     
         114 . A medical device for use in the treatment or prevention of Type I Diabetes, comprising at least one isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37, wherein said device is suitable for subcutaneaously (SC) administering said at least one anti-TNF antibody. 
     
     
         115 . The medical deviced according to  claim 114 , wherein the device is suitable for self-administration and the device is selected from the group consisting of: prefilled syringe, prefilled syringe with an UltraSafe Passive Needle Guard, and VarioJect. 
     
     
         116 . The medical deviced according to  claim 115 , wherein the device is a VarioJect with a 4.5 mm needle length.

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