IL-22 Fc fusion proteins
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.
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.