IP Library › Patent Application 16196743
Patent Application
App. No. 16/196,743

IL-22 POLYPEPTIDES AND IL-22 Fc FUSION PROTEINS AND METHODS OF USE

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Patent No.
US None
App. No.
16/196,743
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.

Claims (34)

1 - 157 . (canceled)

158 . A method of inhibiting microbial infection in the intestine, preserving goblet cells in the intestine during a microbial infection, or enhancing epithelial cell integrity, epithelial cell proliferation, epithelial cell differentiation, epithelial cell migration or epithelial wound healing in the intestine, 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 to an 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, and wherein the Fc region is not glycosylated.

159 . The method of claim 158 , 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.

160 . The method of claim 158 , wherein the epithelial cell is an intestinal epithelial cell.

161 . The method of claim 158 , wherein the amino acid sequence has at least 99% sequence identity to the amino acid sequence of SEQ ID NO:8.

162 . The method of claim 158 , wherein the Fc region comprises an altered glycosylation consensus site.

163 . The method of claim 158 , wherein the Fc region comprises an insertion, a deletion, or a substitution mutation that results in an aglycosylated Fc region.

164 . The method of claim 158 , wherein in the Fc region the amino acid residue at position 297 as in the EU index is changed and/or the amino acid residue at position 299 as in the EU index is changed.

165 . The method of claim 164 , wherein the amino acid residue at position 297 as in the EU index is Gly, Ala, Gln, Asp, or Glu.

166 . The method of claim 165 , wherein the amino acid residue at position 297 as in the EU index is Gly or Ala.

167 . The method of claim 166 , wherein the amino acid residue at position 297 as in the EU index is Gly.

168 . The method of claim 164 , wherein the amino acid residue at position 299 as in the EU index is Ala, Gly, or Val.

169 . The method of claim 158 , wherein the Fc region is an IgG4 Fc region.

170 . The method of claim 158 , 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.

171 . The method of claim 170 , wherein the process further comprises the step of obtaining the IL-22 Fc fusion protein from the cell culture or culture medium.

172 . The method of claim 170 , wherein the host cell is a Chinese hamster ovary (CHO) cell.

173 . The method of claim 158 , wherein the IL-22 Fc fusion protein is a dimeric IL-22 Fc fusion protein.

174 . The method of claim 158 , wherein the IL-22 Fc fusion protein is a monomeric IL-22 Fc fusion protein.

175 . The method of claim 158 , wherein the IL-22 polypeptide comprises the amino acid sequence of SEQ ID NO:4.

176 . The method of claim 158 , wherein the IL-22 polypeptide is a human IL-22 polypeptide.

177 . The method of claim 158 , wherein the IL-22 receptor is a human IL-22 receptor.

178 . The method of claim 158 , wherein the linker comprises the amino acid sequence of SKYGPP (SEQ ID NO:43).

179 . The method of claim 158 , wherein the linker comprises the amino acid sequence of RVESKYGPP (SEQ ID NO:44).

180 . The method of claim 179 , wherein the linker consists of the amino acid sequence of RVESKYGPP (SEQ ID NO:44).

181 . The method of claim 158 , wherein the IL-22 Fc fusion protein comprises the amino acid sequence of SEQ ID NO:8.

182 . The method of claim 158 , wherein the IL-22 Fc fusion protein comprises the amino acid sequence of SEQ ID NO:10.

183 . The method of claim 158 , wherein the IL-22 Fc fusion protein comprises the amino acid sequence of SEQ ID NO:16.

184 . The method of claim 158 , 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.

185 . The method of claim 158 , wherein the IL-22 Fc fusion protein is administered intravenously, subcutaneously, or intraperitoneally.

186 . The method of claim 158 , wherein the subject is co-administered at least one additional therapeutic agent.

187 . The method of claim 159 , wherein the pharmaceutical composition is administered intravenously, subcutaneously, or intraperitoneally.

188 . The method of claim 159 , wherein the pharmaceutical composition comprises an additional therapeutic agent.

189 . The method of claim 158 , wherein the subject is human.