Hyperimmunized egg product for treatment or prevention of coronavirus infection
Inventors
Iyer, Subramanian V. • Chandrasekhar, Satishchandran • Saxena, Uday • KADIYALA, Gopi
Assignees
Kyntox Biotech India Pvt Ltd • Reagene Biosciences Pvt Ltd • Lay Sciences Inc • Prodigy Biotech Inc
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Abstract
In one aspect, the present disclosure is directed to a method for preventing or treating a coronavirus infection 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 coronavirus infection in the subject, wherein the hyperimmunized egg product comprises a therapeutically effective amount of one or more antibodies to the coronavirus. 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 i) a spike (S) protein, an S1 subunit protein, an S2 subunit protein, a receptor binding domain (RBD), and an immunogenic fragment thereof; ii) a nucleocapsid (N) protein, and an immunogenic fragment thereof; iii) a human ACE2 receptor protein, and an immunogenic fragment thereof; and iv) a human coronavirus selected from the group consisting of SARS-CoV, MERS-CoV, SARS-CoV-2, HCoV-HKU1, HCoV-NL63, HCoV-OC43 and HCoV-229E. Methods of preparing the hyperimmunized eggs and egg products are also disclosed.
Core Innovation
The invention relates to treating or preventing coronavirus infection by administering a therapeutically effective amount of a hyperimmunized egg product containing coronavirus-specific antibodies. The hyperimmunized egg product is prepared from whole egg, yolk, or a purified IgY fraction obtained from hyperimmunized eggs.
Hyperimmunization is performed in an egg-producing animal with a composition comprising coronavirus antigens, including SARS-CoV, MERS-CoV, and SARS-CoV-2. The antigens include spike protein (S), S1/S2, the receptor binding domain (RBD), immunogenic fragments, nucleocapsid (N), and human ACE2 receptor, and may be combined with an optional adjuvant.
The method includes preparing the hyperimmunized egg product by dehydrating, spray drying, or freeze drying the whole egg, yolk, or purified IgY fraction from the hyperimmunized eggs. The resulting product may be provided as nanoparticles or microparticles and may further be encapsulated using encapsulating material and one selected encapsulation process.
Claims Coverage
1 independent claim (clm-00001) is directed to a method of preparing a hyperimmunized egg product. The claim set includes multiple dependent refinements that mainly add particle size constraints and encapsulation/formulation options.
Hyperimmunization using SEQ ID NO: 19 antigen
Hyperimmunizing an egg-producing animal with a composition comprising an antigen having the amino acid sequence of SEQ ID NO: 19.
Drying whole egg, yolk, or purified IgY fraction to form the product
Preparing a hyperimmunized egg product from one or more eggs produced by the animal by dehydrating, spray drying, or freeze drying of whole egg, yolk or a purified IgY fraction.
Nanoparticle-sized hyperimmunized egg product
Providing the hyperimmunized egg product as nanoparticles with a diameter less than 1000 nm.
Narrow nanoparticle diameter range
Providing the hyperimmunized egg product as nanoparticles with a diameter ranging from about 10 to 100 nm.
Microparticle-sized hyperimmunized egg product
Providing the hyperimmunized egg product as microparticles with a diameter of about 0.1 to 10 microns.
Encapsulation of the hyperimmunized egg product
Encapsulating the hyperimmunized egg product in an encapsulating material.
Selected encapsulation process
Carrying out the encapsulation using one selected process among multi-walled microencapsulation, hot melt encapsulation, phase separation encapsulation, spontaneous emulsion, solvent evaporation microencapsulation, solvent removal microencapsulation, or coacervation.
The claims cover preparing a hyperimmunized egg product by hyperimmunizing an egg-producing animal with an antigen defined by SEQ ID NO: 19, then producing the product by dehydrating, spray drying, or freeze drying whole egg, yolk, or purified IgY. Dependent claim coverage further specifies nanoparticle and microparticle product forms and adds encapsulation using selected encapsulation processes.
Stated Advantages
Documented Applications
Treating or preventing coronavirus infection by administering a therapeutically effective amount of a hyperimmunized egg product containing coronavirus-specific antibodies.
The description includes supporting experimental and clinical testing concepts, including generation of anti-RBD IgY activity and assessing inhibition of ACE2-RBD binding and neutralization in PRNT, as well as a pilot human study assessing oral IgY effectiveness in increasing salivary neutralizing activity after oral dosing.
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