Anti-IL-22 antibodies, antibody fragments, their immunoconjugates and uses thereof
Inventors
Short, Jay M. • Frey, Gerhard • Chang, Hwai Wen • Boyle, William
Assignees
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Publication Number
US-11834472-B2
Publication Date
2023-12-05
Expiration Date
Abstract
An anti-IL-22 antibody or antibody fragment that binds to both human IL-22 and a mammalian IL-22 as well as modified anti-IL-22 antibodies and antibody fragments. Pharmaceutical compositions and kits comprising the antibody or antibody fragment are also provided. Also provided are methods for treatment of various IL-22 mediated conditions and diseases.
Core Innovation
The invention relates to anti-IL-22 antibodies and antigen binding fragments comprising specified light chain variable region and heavy chain variable region complementarity determining region (CDR) amino acid sequences. The antibodies include light chain CDR1, CDR2, and CDR3 defined by selected SEQ ID NOs and heavy chain CDR1, CDR2, and CDR3 defined by selected SEQ ID NOs, with additional character-variable constraints on the positions X1 to X10 and limits on how many positions may differ.
The invention further encompasses anti-IL-22 antibodies having light and heavy chain variable regions with high sequence identity to defined SEQ ID ranges. In particular, the antibodies comprise a light chain variable region having at least 90% sequence identity to one of SEQ ID NOS: 7-12, with three CDRs identical to the corresponding CDRs of the SEQ ID-derived light chain variable region, and a heavy chain variable region having at least 90% sequence identity to one of SEQ ID NOS: 13-18, with three CDRs identical to the corresponding CDRs of the SEQ ID-derived heavy chain variable region.
The described subject matter includes cross-reactive anti-IL-22 binding behavior and functional inhibition of IL-22-driven signaling and responses. The document reports inhibition of IL-22-induced Stat3 phosphorylation and reduction of IL-22-driven CXCL1 production, and it reports an inhibition of IL-22-induced acute phase response and improved efficacy in an imiquimod-induced psoriasis mouse model with reduced side effects versus dexamethasone.
Claims Coverage
The partial content provides two independent claims, clm-00001 and clm-00028, with additional dependent claim coverage for sequence variants and functional or formulation/conjugate features. Overall, the claim set centers on anti-IL-22 antibodies and antigen binding fragments defined by specific CDR amino acid sequences or by high-identity variable-region sequence relationships to defined SEQ ID sets, with additional constraints limiting which substitutions are permitted.
Cdr-defined anti-IL-22 antibody variable regions with substitution constraints
An anti-IL-22 antibody or antigen binding fragment comprising a light chain variable region with LCDR1, LCDR2, and LCDR3 having amino acid sequences selected from SEQ ID NO:1, SEQ ID NO:2, and SEQ ID NO:3, and a heavy chain variable region with HCDR1, HCDR2, and HCDR3 having amino acid sequences selected from SEQ ID NO:4, SEQ ID NO:5, and SEQ ID NO:6, with X1 to X10 constraints and provisos limiting excluded characters and the number of differing positions.
High-identity anti-IL22 antibody variable regions with identical CDRs
An anti-IL22 antibody or antigen binding fragment comprising a light chain variable region with at least 90% sequence identity to one of SEQ ID NOS:7-12, wherein the light chain variable region has three complementarity determining regions identical to the corresponding regions of the selected light chain variable region, and a heavy chain variable region with at least 90% sequence identity to one of SEQ ID NOS:13-18, wherein the heavy chain variable region has three complementarity determining regions identical to the corresponding regions of the selected heavy chain variable region.
Across the independent claims, coverage is provided for anti-IL-22 antibodies and antigen binding fragments defined by either specific CDR amino acid sequence selections with explicit positional character-substitution limits, or by high sequence identity of light and heavy variable regions to specified SEQ ID ranges while maintaining identical CDRs to the corresponding SEQ ID-derived regions.
Stated Advantages
Inhibition of IL-22-induced Stat3 phosphorylation.
Reduction of IL-22-driven CXCL1 production.
Inhibition of IL-22-induced acute phase response.
Improved efficacy in an imiquimod-induced psoriasis mouse model.
Reduced side effects versus dexamethasone.
Documented Applications
Therapeutic use in inflammatory or autoimmune disorders mediated by IL-22, including psoriasis.
Therapeutic use in IL-22-mediated cancers.
Diagnostic use, including a diagnostic kit and ELISA.
Immunoconjugates including antibody-drug conjugates and labeled or radioactive conjugates.
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