Methods for preventing or treating cardiovascular conditions using il-22 fc fusion proteins

Patent metadata

Field	Value
Publication number	US-11136365-B2
Application number	US-201816196823-A
Country	US
Kind code	B2
Filing date	Nov 20, 2018
Priority date	Mar 15, 2013
Publication date	Oct 5, 2021
Grant date	Oct 5, 2021

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 for treating a cardiovascular condition in a subject, which condition includes a pathology of atherosclerotic plaque formation, the method comprising administering to a subject in need thereof a therapeutically effective amount of an IL-22 Fc fusion protein,
wherein the IL-22 Fc fusion protein binds to IL-22 receptor and comprises an IL-22 polypeptide linked by a linker to an IgG4 Fc region that is not glycosylated, wherein the IL-22 Fc fusion protein 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 of RVESKYGPP (SEQ ID NO:44).

2. The method of claim 1 , wherein the cardiovascular condition is selected from the group consisting of coronary artery disease, coronary microvascular disease, stroke, carotid artery disease, peripheral arterial disease, and chronic kidney disease.

3. The method of claim 1 , wherein the subject is human.

4. The method of claim 1 , wherein the Fc region comprises an altered glycosylation consensus site.

5. The method of claim 1 , wherein the Fc region comprises an amino acid insertion, deletion, or substitution that results in an aglycosylated Fc region.

6. The method of claim 1 , wherein in the Fc region the amino acid residue at position 297 as in the EU index is substituted and/or the amino acid residue at position 299 as in the EU index is substituted.

7. The method of claim 6 , wherein the amino acid residue at position 297 as in the EU index is Gly, Ala, Gln, Asp, or Glu.

8. The method of claim 7 , wherein the amino acid residue at position 297 as in the EU index is Gly or Ala.

9. The method of claim 8 , wherein the amino acid residue at position 297 as in the EU index is Gly.

10. The method of claim 6 , wherein the amino acid residue at position 299 as in the EU index is Ala, Gly, or Val.

11. The method of claim 1 , wherein the IL-22 polypeptide is a human IL-22 polypeptide.

12. The method of claim 1 , wherein the IL-22 polypeptide comprises the amino acid sequence of SEQ ID NO:4.

13. The method of claim 1 , wherein the IL-22 receptor is a human IL-22 receptor.

14. The method of claim 1 , wherein the amino acid sequence has at least 99% sequence identity to the amino acid sequence of SEQ ID NO:8.

15. The method of claim 1 , wherein the IL-22 Fc fusion protein comprises the amino acid sequence of SEQ ID NO:8.

16. The method of claim 1 , wherein the IL-22 Fc fusion protein comprises the amino acid sequence of SEQ ID NO:10.

17. The method of claim 1 , wherein the IL-22 Fc fusion protein comprises the amino acid sequence of SEQ ID NO:16.

18. The method of claim 1 , wherein the IL-22 Fc fusion protein consists of the amino acid sequence of SEQ ID NO:8, SEQ ID NO:10, or SEQ ID NO:16.

19. The method of claim 1 , wherein the IL-22 Fc fusion protein is produced by a process comprising the step of culturing a host cell capable of expressing the IL-22 Fc fusion protein under conditions suitable for expression of the IL-22 Fc fusion protein.

20. The method of claim 19 , wherein the process further comprises the step of obtaining the IL-22 Fc fusion protein from the cell culture or culture medium.

21. The method of claim 19 , wherein the host cell is a Chinese hamster ovary (CHO) cell.

22. The method of claim 1 , wherein the IL-22 Fc fusion protein is a dimeric IL-22 Fc fusion protein.

23. The method of claim 1 , wherein the IL-22 Fc fusion protein is a monomeric IL-22 Fc fusion protein.

24. The method of claim 1 , wherein the IL-22 Fc fusion protein is administered intravenously, subcutaneously, or intraperitoneally.

25. The method of claim 1 , wherein the subject is co-administered at least one additional therapeutic agent.

26. The method of claim 1 , wherein the IL-22 Fc fusion protein is administered in a pharmaceutical composition comprising the IL-22 Fc fusion protein and at least one pharmaceutically acceptable carrier.

27. The method of claim 26 , wherein the pharmaceutical composition is administered intravenously, subcutaneously, or intraperitoneally.

28. The method of claim 26 , wherein the pharmaceutical composition comprises an additional therapeutic agent.

Assignees

• Genentech Inc

Inventors

• Scheer Justin
• Ouyang Wenjun
• Vandlen Richard
• Hass Philip E
• Stefanich Eric Gary
• Kolumam Ganesh A
• Wang Xiaoting
• Ross Jed
• Van Bruggen Nicholas

Classifications

• 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

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61P43/00

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

• A61P1/04

  for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants · CPC title

• A61P3/04

  Anorexiants; Antiobesity agents · CPC title