US2021347876A1PendingUtilityA1

Therapies for treating inflammatory disorders

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Assignee: MICROPHARM LTDPriority: Jan 27, 2017Filed: Jul 19, 2021Published: Nov 11, 2021
Est. expiryJan 27, 2037(~10.5 yrs left)· nominal 20-yr term from priority
Inventors:John LandonRuth Elizabeth Coxon
C07K 2317/33C07K 2317/76A61K 39/39591A61K 9/0053A61P 1/04C07K 2317/20A61K 2039/542C07K 2317/94C07K 2317/23C07K 2317/92A61P 31/04A61P 29/00C07K 2317/12A61P 31/00A61P 43/00A61K 47/42A61P 37/06A61P 37/08A61P 9/10C07K 16/248A61K 47/46C07K 16/241C07K 2317/55A61P 25/32A61K 2039/505
48
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Claims

Abstract

The present invention is directed to an antibody composition for oral administration comprising intact blood-derived polyclonal antibodies that bind to a human tumour necrosis factor α (TNFα), and means for protecting the antibodies during gastrointestinal transit, as well as methods for manufacturing, kits, and therapeutic uses of the same.

Claims

exact text as granted — not AI-modified
1 . An antibody composition for oral administration comprising intact blood-derived polyclonal antibodies that bind to a human tumour necrosis factor α (TNFα), and means for protecting the antibodies during gastrointestinal transit. 
     
     
         2 . The antibody composition according to  claim 1 , wherein the blood-derived polyclonal antibodies are ovine blood-derived polyclonal antibodies. 
     
     
         3 . The antibody composition according to  claim 1 , wherein the blood derived polyclonal antibodies are equine blood-derived polyclonal antibodies. 
     
     
         4 . The antibody composition according to any one of the preceding claims, wherein the means for protecting the antibodies comprises at least a protease inhibitor. 
     
     
         5 . The antibody composition according to  claim 4 , wherein the protease inhibitor is one or more selected from the Bowman-Birk inhibitor family of proteins. 
     
     
         6 . The antibody composition according to any one of the preceding claims formulated as a liquid. 
     
     
         7 . The antibody composition according to any one of the preceding claims, wherein the means for protecting the antibodies comprises a means obtainable from egg white. 
     
     
         8 . The antibody composition according to any one of the preceding claims, wherein the means for protecting the antibodies comprises egg white, preferably powdered egg white. 
     
     
         9 . The antibody composition according to any one of the preceding claims, wherein the means for protecting the antibodies comprises one or more antacid(s). 
     
     
         10 . The antibody composition according to any one of the preceding claims, wherein the means for protecting the antibodies comprises one or more of:
 a. a polypeptide which binds specifically to and suppresses or inactivates the proteolytic activity of trypsin and/or chymotrypsin; and/or   b. an antibody that binds to trypsin and/or chymotrypsin and suppresses or inactivates the protease activity of said trypsin and/or chymotrypsin; and/or   c. an antacid.   
     
     
         11 . The antibody composition according to any one of the preceding claims, wherein the composition comprises an antacid and:
 a. a polypeptide which binds specifically to and suppresses or inactivates the proteolytic activity of trypsin and/or chymotrypsin; and/or   b. an antibody that binds to trypsin and/or chymotrypsin and inactivates the protease activity of said trypsin and/or chymotrypsin.   
     
     
         12 . The antibody composition according to any one of the preceding claims, wherein the means comprises one or more of ovomucoid, ovostatin, ovomacroglobulin, or combinations thereof. 
     
     
         13 . The antibody composition according to any one of the preceding claims, wherein at least 5% of the total antibodies present in the composition bind to TNFα. 
     
     
         14 . The antibody composition according to any one of the preceding claims, wherein at least 10% of the total antibodies present in the composition bind to TNFα. 
     
     
         15 . A method for manufacturing intact blood-derived polyclonal antibodies that bind to human tumour necrosis factor α (TNFα), said method comprising obtaining a blood sample from a non-human mammal that has been administered an immunogen comprising human TNFα or a fragment thereof. 
     
     
         16 . The method according to  claim 15 , wherein the non-human mammal is an ovine non-human mammal. 
     
     
         17 . The method according to  claim 15  or  16  further comprising obtaining serum from the blood sample. 
     
     
         18 . The method according to  claim 15 , wherein the non-human mammal is an equine non-human mammal. 
     
     
         19 . The method according to  claim 15  or  18  further comprising obtaining plasma from the blood sample. 
     
     
         20 . The method according to any one of  claims 15 - 19  further comprising purifying antibodies using sodium sulphate precipitation or caprylic acid precipitation. 
     
     
         21 . An antibody obtainable by the method of any one of  claims 15 - 20 . 
     
     
         22 . An antibody composition according to any one of  claims 1 - 14  for use in treating an inflammatory disorder, wherein the antibody composition is orally administered to a subject. 
     
     
         23 . Use of an antibody composition according to any one of  claims 1 - 14  in the manufacture of a medicament for treating an inflammatory disorder, wherein the antibody composition is orally administered to a subject. 
     
     
         24 . A method of treating an inflammatory disorder comprising orally administering an antibody composition according to any one of  claims 1 - 14 . 
     
     
         25 . The antibody composition for use, use or method according to any one of  claims 22 - 24 , wherein the antibodies and the means for protecting the antibodies are administered simultaneously. 
     
     
         26 . The antibody composition for use, use or method according to any one of  claims 22 - 24 , wherein the antibodies and the means for protecting the antibodies are administered separately. 
     
     
         27 . The antibody composition for use, use or method according to any one of  claims 22 - 26 , wherein the inflammatory disorder is septic shock. 
     
     
         28 . The antibody composition for use, use or method according to any one of  claims 22 - 27 , wherein the inflammatory disorder is a gastrointestinal disorder, preferably an intestinal disorder. 
     
     
         29 . The antibody composition for use, use or method according to any one of  claims 22 - 28 , wherein the inflammatory disorder is an inflammatory bowel disease, an intestinal infection, a graft vs. host disorder, a disorder caused by: non-steroidal anti-inflammatory drugs, stress, alcohol, bowel surgery, ischaemia and reperfusion, food allergy, or combinations thereof. 
     
     
         30 . The antibody composition for use, use or method according to any one of  claims 22 - 29 , wherein the inflammatory disorder is an inflammatory bowel disease selected from ulcerative colitis, Crohn's disease, or combinations thereof. 
     
     
         31 . The antibody composition for use, use or method according to any one of  claims 22 - 30 , wherein the antibody composition is administered to a subject at a dose of 2 g or less daily. 
     
     
         32 . The antibody composition for use, use or method according to any one of  claims 22 - 31 , wherein the antibody composition is administered to a subject at a dose of 1 g or less daily. 
     
     
         33 . A kit comprising an antibody composition according to any one of  claims 1 - 14 , and instructions for use of same. 
     
     
         34 . A foodstuff comprising an antibody composition according to any one of  claims 1 - 14 . 
     
     
         35 . The foodstuff according to  claim 34 , wherein the foodstuff is a dairy product, preferably a dairy product selected from yogurt, cheese, or milk. 
     
     
         36 . The foodstuff according to  claim 34  or  35  further comprising a probiotic, and optionally a prebiotic.

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