Methods of treating inflammatory bowel disease using IL-22 Fc fusion proteins

Patent metadata

Field	Value
Publication number	US-10160793-B2
Application number	US-201414214161-A
Country	US
Kind code	B2
Filing date	Mar 14, 2014
Priority date	Mar 15, 2013
Publication date	Dec 25, 2018
Grant date	Dec 25, 2018

Abstract

The invention relates to IL-22 polypeptides, IL-22 Fc fusion proteins and IL-22 agonists, composition comprising the same, methods of making and methods of using the composition for the treatment of diseases. The invention also relates to IL-22 receptor associated reagents and methods of use thereof.

First claim

What is claimed is:

1. A method of treating IBD, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein comprising an IL-22 polypeptide linked to an IgG4 Fc region by a linker, wherein the Fc region is not glycosylated, and wherein the linker consists of the amino acid sequence RVESKYGPP (SEQ ID NO: 44).

2. A method of treating IBD, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein consisting of the amino acid sequence of SEQ ID NO:16.

3. The method of claim 2 or 1 , wherein the IBD is ulcerative colitis.

4. The method of claim 2 or 1 , wherein the IBD is Crohn's disease.

5. A method of treating IBD, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein consisting of the amino acid sequence of SEQ ID NO:8.

6. A method of treating inflammatory bowel disease (IBD), the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein, the IL-22 Fc fusion protein comprising an IL-22 polypeptide linked by a linker to an IgG4 Fc region that is not glycosylated, wherein the IL-22 Fc fusion protein binds to IL-22 receptor and comprises an amino acid sequence having at least 98% sequence identity to the amino acid sequence of SEQ ID NO:8, and wherein the linker consists of the amino acid sequence RVESKYGPP (SEQ ID NO: 44).

7. The method of claim 6 , wherein the amino acid sequence of the IL-22 Fc fusion protein has at least 99% sequence identity to the amino acid sequence of SEQ ID NO:8.

8. The method of claim 6 , wherein the IL-22 Fc fusion protein comprises the amino acid sequence of SEQ ID NO:10.

9. The method of claim 6 , wherein the IL-22 Fc fusion protein comprises the amino acid sequence of SEQ ID NO:16.

10. The method of claim 6 , wherein the IL-22 polypeptide is a human IL-22 polypeptide.

11. The method of claim 6 , wherein the IL-22 polypeptide comprises the amino acid sequence of SEQ ID NO:4.

12. The method of claim 6 , wherein the IL-22 receptor is a human IL-22 receptor.

13. The method of claim 6 , wherein the amino acid residue at position 297 as in the EU index of the IgG4 Fc region is Gly.

14. The method of claim 6 , wherein the amino acid residue at position 297 as in the EU index of the IgG4 Fc region is Ala.

15. The method of claim 6 , wherein the IL-22 Fc fusion protein is a dimeric IL-22 Fc fusion protein.

16. The method of claim 6 , wherein the IL-22 Fc fusion protein is a monomeric IL-22 Fc fusion protein.

17. The method of claim 6 , wherein the IL-22 Fc fusion protein is administered in a formulation comprising a pharmaceutically acceptable carrier.

18. The method of claim 6 , wherein the subject is administered at least one additional therapeutic agent.

19. The method of claim 6 , wherein the IL-22 Fc fusion protein is administered intravenously.

20. The method of claim 6 , wherein the IL-22 Fc fusion protein is administered subcutaneously.

21. The method of claim 6 , wherein the IL-22 Fc fusion protein is administered intraperitoneally.

22. The method of claim 6 , wherein the IBD is ulcerative colitis.

23. The method of claim 6 , wherein the IBD is Crohn's disease.

24. The method of claim 6 , wherein the subject is a human.

25. A method of treating IBD, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein comprising the amino acid sequence of SEQ ID NO:8.

26. The method of any one of claims 5 , 2 , 1 wherein the subject is a human.

27. A method of treating ulcerative colitis, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein comprising the amino acid sequence of SEQ ID NO:8.

28. A method of treating ulcerative colitis, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein consisting of the amino acid sequence of SEQ ID NO:8.

29. A method of treating Crohn's disease, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein comprising the amino acid sequence of SEQ ID NO:8.

30. A method of treating Crohn's disease, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein consisting of the amino acid sequence of SEQ ID NO:8.

Assignees

• Genentech Inc

Inventors

• Scheer Justin
• Ouyang Wenjun
• Vandlen Richard
• Hass Philip E
• Stefanich Eric Gary
• Wang Xiaoting

Classifications

• A61P39/02

  Antidotes · CPC title

• A61P9/12

  Antihypertensives · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P3/06

  Antihyperlipidemics · CPC title

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title