Hyperimmunized egg product for treating or preventing alcoholic liver disease and graft- versus-host disease
Inventors
Iyer, Subramanian V. • Patel, Sunny
Assignees
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Publication Number
US-12435125-B2
Publication Date
2025-10-07
Expiration Date
Abstract
In one aspect, the present disclosure is directed to a method for preventing or treating alcoholic liver disease or graft-versus-host disease in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a hyperimmunized egg product obtained from an egg-producing animal, thereby preventing or treating the alcoholic liver disease or the graft-versus-host disease in the subject, wherein the hyperimmunized egg product comprises a therapeutically effective amount of one or more antibodies to an antigen selected from the group consisting of Enterococcus faecalis, Enterococcus faecalis cytolysin toxin, and Enterococcus faecium. The present disclosure is also directed to hyperimmunized eggs and egg products produced by an animal that has been hyperimmunized with an antigen selected from the group consisting of Enterococcus faecalis, isolated Enterococcus faecalis cytolysin toxin, and Enterococcus faecium. Methods of preparing the hyperimmunized eggs and egg products are also disclosed.
Core Innovation
The invention relates to hyperimmunized egg products produced by an animal that has been hyperimmunized with an antigen selected from Enterococcus faecalis that expresses cytolysin toxin and isolated Enterococcus faecalis cytolysin toxin. The hyperimmunized egg contains increased levels of antibodies to the Enterococcus faecalis cytolysin toxin relative to an egg from an animal that has not been hyperimmunized, and the antibody titer in the hyperimmunized egg is at least 8000.
The disclosure further provides hyperimmunized egg-derived products, including whole egg, egg yolk/egg powder, and purified or partially purified IgY (IgY fractions). It describes compositions and delivery forms in which the antigen-specific IgY is provided via egg-based materials, including pharmaceutical compositions with pharmaceutically acceptable carriers.
The document describes the use of these hyperimmunized egg products to prevent or treat alcoholic liver disease (ALD) and graft-versus-host disease (GVHD). The disclosure also describes preclinical and experimental rationale showing anti-Enterococcus faecalis and anti-cytolysin activity, including in vitro inhibition of Enterococcus faecalis growth and reduction of liver injury in a humanized germ-free mouse ALD model.
Claims Coverage
The independent claim family centers on a hyperimmunized egg with increased antibody levels to Enterococcus faecalis cytolysin toxin, with antibody titers meeting a specified threshold. Three inventive features are reflected across the claims, with dependent claims further refining egg-derived compositions and formulations.
Hyperimmunized egg with increased anti-cytolysin toxin antibodies
A hyperimmunized egg produced by an animal that has been hyperimmunized with an antigen selected from Enterococcus faecalis that expresses cytolysin toxin and isolated Enterococcus faecalis cytolysin toxin, wherein the level of antibodies to Enterococcus faecalis cytolysin toxin in the hyperimmunized egg is increased relative to an egg from an animal that has not been hyperimmunized, and wherein the titer of antibodies to Enterococcus faecalis cytolysin toxin in the hyperimmunized egg is at least 8000.
Pharmaceutical composition with egg yolk/egg powder and pharmaceutically acceptable carrier
A pharmaceutical composition comprising egg yolk, egg yolk powder, or whole egg powder obtained from the hyperimmunized egg, together with a pharmaceutically acceptable carrier.
Nanoparticle or emulsion formulation of egg-derived material
A pharmaceutical composition including egg yolk, egg yolk powder, or whole egg powder formulated as nanoparticles or as an emulsion.
Overall, the claims coverage focuses on generating a hyperimmunized egg with increased antibody levels to Enterococcus faecalis cytolysin toxin at a specified titer, and on providing egg-derived pharmaceutical compositions, including carrier-containing and nanoparticle or emulsion formulations.
Stated Advantages
Reduces liver injury in a humanized germ-free mouse ALD model, including lower serum ALT and improved histology/steatosis.
Improves outcomes in the disclosed preclinical ALD context compared with control IgY.
Provides in vitro inhibition of Enterococcus faecalis growth.
Documented Applications
To prevent or treat alcoholic liver disease (ALD), including alcoholic hepatitis.
To prevent or treat graft-versus-host disease (GVHD).
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