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Publication Number
US-10946078-B2
Publication Date
2021-03-16
Expiration Date
Abstract
The present invention relates to compositions, immunogenic or vaccine compositions and pharmaceutical compositions for the prevention or treatment of canine atopic dermatitis (CAD). Furthermore, the invention provides methods for preventing or treating CAD. The compositions of the invention induce efficient immune responses, in particular antibody responses, in dogs and are, therefore, useful for the treatment and/or prevention of CAD.
Core Innovation
The disclosure describes preventing or treating canine atopic dermatitis (CAD) of a canidae by administering an immunogenic composition that links a canine Interleukin-31 (cIL-31) antigen to a virus-like particle (VLP). The composition includes a core particle with at least one first attachment site and at least one cIL-31 antigen with at least one second attachment site, wherein the first and second attachment sites are linked via at least one non-peptide covalent bond.
In the disclosed construct, the cIL-31 antigen comprises a protein with an amino sequence selected from SEQ ID NO:22 or a protein having at least 90% sequence identity with SEQ ID NO:22. The disclosure further specifies VLP embodiments, including modified cucumber mosaic virus (CMV) VLPs, where modified CMV polypeptides incorporate T helper (Th) cell epitopes into or in association with CMV coat protein sequences.
The disclosed immunogenic compositions are stated to induce strong cIL-31-specific antibody responses, reduce IL-31 levels, and correlate with clinical improvements in CAD, including reduced itching and skin lesion severity measured using ADLI and PVAS. The disclosure links these outcomes to cIL-31-specific IgG titers in dog data, supporting the therapeutic intent of presenting cIL-31 using CMV VLPs modified with universal Th cell epitopes.
Claims Coverage
The document includes two independent claims: a method claim and a composition claim. Each claim centers on linking a VLP core particle to a cIL-31 antigen via non-peptide covalent bonds, with the cIL-31 antigen restricted to SEQ ID NO:22 or sequence identity to SEQ ID NO:22 (and in dependents, defined Th-epitope and CMV-polypeptide configurations).
Non-peptide covalent linkage between core particle and cIL-31 antigen
A method of preventing or treating canine atopic dermatitis (CAD) of a canidae, comprising administering an effective amount of a composition where a core particle with at least one first attachment site and at least one canine Interleukin-31 antigen (cIL-31 antigen) with at least one second attachment site are linked through the first and second attachment sites via at least one non-peptide covalent bond.
cIL-31 antigen sequence restriction to SEQ ID NO:22 or ≥90% identity
The cIL-31 antigen comprises a protein with the amino sequence selected from SEQ ID NO:22 or a protein with an amino acid sequence of at least 90%, sequence identity with SEQ ID NO:22.
VLP-linked cIL-31 antigen composition using non-peptide covalent bonds
A composition comprising a virus-like particle (VLP) with at least one first attachment site and at least one canine Interleukin-31 antigen (cIL-31 antigen) with at least one second attachment site, wherein the VLP and cIL-31 antigen are linked through the first and second attachment site via at least one non-peptide covalent bond.
cIL-31 antigen sequence restriction to SEQ ID NO:22 or ≥90% identity in the composition
The cIL-31 antigen in the composition comprises a protein with the amino acid sequence selected from SEQ ID NO:22 or a protein with an amino acid sequence of at least 90%, sequence identity with SEQ ID NO:22.
Overall, claim coverage is anchored on a non-peptide covalent linkage between a VLP core particle and a canine IL-31 antigen, with the IL-31 antigen defined by SEQ ID NO:22 or at least 90% sequence identity to SEQ ID NO:22. Dependent claims further narrow the VLP to modified CMV VLPs with Th cell epitope insertions or replacements and additional specified sequence-identity constraints and named epitope and antigen sequence options.
Stated Advantages
Induces strong cIL-31-specific antibody responses.
Reduces IL-31 levels.
Correlates with clinical improvements in canine atopic dermatitis, including reduced itching.
Correlates with reduced skin lesion severity measured by ADLI and PVAS.
Documented Applications
Preventing or treating canine atopic dermatitis (CAD) of a canidae by administering an immunogenic composition comprising a VLP linked to a cIL-31 antigen via non-peptide covalent bonds.
Compositions based on modified cucumber mosaic virus (CMV) VLPs presenting cIL-31 and modified with universal Th cell epitopes, for CAD immunogenic/therapeutic use.
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