IL-22 Fc fusion proteins

Patent metadata

Field	Value
Publication number	US-9815880-B2
Application number	US-201615217790-A
Country	US
Kind code	B2
Filing date	Jul 22, 2016
Priority date	Mar 15, 2013
Publication date	Nov 14, 2017
Grant date	Nov 14, 2017

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. An interleukin (IL)-22 Fc fusion protein that binds to IL-22 receptor, said IL-22 Fc fusion protein comprising an IL-22 polypeptide linked to an IgG4 Fc region by a linker, 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, wherein the Fc region is not glycosylated at amino acid residue 297, and wherein the linker consists of the amino acid sequence of RVESKYGPP (SEQ ID NO:44).

2. The IL-22 Fc fusion protein of claim 1 , wherein the IL-22 polypeptide comprises the amino acid sequence of SEQ ID NO:4.

3. The IL-22 Fc fusion protein of claim 1 , wherein the amino acid residue 297 of the CH2 domain is Gly or Ala.

4. An IL-22 Fc fusion protein that comprises the amino acid sequence of SEQ ID NO:8.

5. An IL-22 Fc fusion protein that comprises the amino acid sequence of SEQ ID NO:10.

6. An IL-22 Fc fusion protein consisting of the amino acid sequence of SEQ ID NO:8 or SEQ ID NO:10.

7. The IL-22 Fc fusion protein of any one of claims 4 - 6 and 1 , wherein the IL-22 Fc fusion protein is a monomeric IL-22 Fc fusion protein.

8. The IL-22 Fc fusion protein of any one of claims 4 - 6 and 1 , wherein the IL-22 Fc fusion protein is a dimeric IL-22 Fc fusion protein.

9. The IL-22 Fc fusion protein of any one of claims 4 - 6 and 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.

10. The IL-22 Fc fusion protein of claim 9 , wherein the process further comprises the step of obtaining the IL-22 Fc fusion protein from the cell culture or culture medium.

11. The IL-22 Fc fusion protein of claim 9 , wherein the host cell is a Chinese hamster ovary (CHO) cell.

12. A pharmaceutical composition comprising the IL-22 Fc fusion protein according to claim 1 and at least one pharmaceutically acceptable carrier.

13. The pharmaceutical composition of claim 12 , wherein the IL-22 Fc fusion protein comprises an amino acid sequence having at least 99% sequence identity to the amino acid sequence of SEQ ID NO:8.

14. A pharmaceutical composition comprising an IL-22 Fc fusion protein that comprises the amino acid sequence of SEQ ID NO:8 and at least one pharmaceutically acceptable carrier.

15. A pharmaceutical composition comprising an IL-22 Fc fusion protein that comprises the amino acid sequence of SEQ ID NO:10 and at least one pharmaceutically acceptable carrier.

16. The pharmaceutical composition of any one of claims 12 - 15 , wherein the IL-22 Fc fusion protein is produced in a CHO cell.

17. The pharmaceutical composition of any one of claims 12 - 15 , further comprising an additional therapeutic agent.

18. A pharmaceutical composition comprising an IL-22 Fc fusion protein consisting of the amino acid sequence of SEQ ID NO:8 or SEQ ID NO:10, and at least one pharmaceutically acceptable carrier.

Assignees

• Genentech Inc

Inventors

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

Classifications

• A61P9/12

  Antihypertensives · CPC title

• A61P3/06

  Antihyperlipidemics · CPC title

• A61P9/00

  Drugs for disorders of the cardiovascular system · CPC title

• A61P39/02

  Antidotes · 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