Anti-CD6 antibody-growth factor complex for treating autoimmune diseases
Inventors
Casimiro, Jose Enrique Montero • Roep, Bart Otto • Williams, John Charles
Assignees
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Publication Number
US-12358998-B2
Publication Date
2025-07-15
Expiration Date
Abstract
Provided herein are, inter alia, anti-CD6 antibody-growth factor complexes including an anti-CD6 antibody portion bound to a growth factor protein (e.g., EGF) through a linker, which may be cleavable by a protease (e.g., diabetic microenvironment specific protease). The compositions provided herein are, inter alia, useful for the treatment of autoimmune diseases (e.g., type I diabetes).
Core Innovation
The invention relates to an anti-CD6 antibody-growth factor complex for treating autoimmune disease. The complex comprises an anti-CD6 antibody or antigen-binding fragment thereof and a growth factor protein or fragment thereof, and the growth factor protein is bound to the anti-CD6 antibody through a chemical linker.
In the described complex, the growth factor protein is an epidermal growth factor receptor (EGFR) signaling molecule, such as EGF. The anti-CD6 antibody portion comprises the complementary-determining region H1, H2, H3, L1, L2, and L3 sequences of itolizumab.
The disclosed concept includes cleavable linker options and the idea that the linker can enable release or activation in a diabetic microenvironment via a protease site. The document further provides context on meditope-enabled anti-CD6 antibodies and functional mechanisms including targeting CD6+ lymphocytes while preserving or restoring target cells.
Claims Coverage
The document includes one independent claim, defining an anti-CD6 antibody-growth factor complex with an anti-CD6 antibody chemically linked to an EGFR signaling growth factor protein. Dependent claims add itolizumab CDR sequence inclusion, specific EGFR ligand selections, protease-cleavable linker options, pharmaceutical composition coverage, and nucleic acid coverage.
Anti-CD6 antibody linked to EGFR signaling molecule via chemical linker
An anti-CD6 antibody-growth factor complex comprising an anti-CD6 antibody or antigen-binding fragment thereof and a growth factor protein or fragment thereof, wherein the growth factor protein is bound to the anti-CD6 antibody or antigen-binding fragment thereof through a chemical linker, and wherein the growth factor protein is an epidermal growth factor receptor (EGFR) signaling molecule.
Itolizumab CDR sequence inclusion in anti-CD6 antibody
The anti-CD6 antibody or antigen-binding fragment thereof comprises the complementary-determining region H1, H2, H3, L1, L2, and L3 sequences of itolizumab.
Antibody-linker architecture with protease-cleavable linker options
A complex characterized by linker options including MMP2-cleavable linker, MMP9-cleavable linker, or granzyme-cleavable linker, and the possibility that either the first chemical linker or the second chemical linker is a protease-cleavable linker.
Selected EGFR signaling molecule ligands
The complex having an EGFR signaling molecule selected from epidermal growth factor, betacellulin, heparin-binding EGF-like growth factor, transforming growth factor α, amphiregulin, epigen, or epiregulin.
Pharmaceutical composition with therapeutically effective amount and excipient
A pharmaceutical composition including a therapeutically effective amount of the complex together with a pharmaceutically acceptable excipient.
Overall, the claim coverage centers on an anti-CD6 antibody-growth factor complex in which an itolizumab-based anti-CD6 antibody is chemically linked to an EGFR signaling molecule growth factor protein, with dependent coverage for linker options, EGFR ligand selections, and pharmaceutical composition.
Stated Advantages
The linker can enable release or activation in a diabetic microenvironment via a protease site.
Targeting CD6+ lymphocytes while preserving or restoring target cells.
EGF-mediated β-cell protection.
Documented Applications
Therapeutic use in autoimmune diseases, including Type I diabetes.
Therapeutic use in multiple sclerosis.
Therapeutic use in inflammatory bowel disease.
Therapeutic use in graft versus host disease.
Therapeutic use via CD6+ lymphocyte targeting/proliferation inhibition and EGF-mediated β-cell protection.
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