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

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 a hyperimmunized egg produced by an animal that has been hyperimmunized with an antigen consisting of the amino acid sequence of SEQ ID NO: 19. The level of antibodies to the antigen in the hyperimmunized egg is increased relative to an egg from an animal that has not been hyperimmunized, and the disclosure includes hyperimmunized egg products derived from such hyperimmunized eggs.

The hyperimmunized egg products include whole egg, egg yolk, and purified or partially purified IgY antibody fractions associated with the targeted coronavirus antigen(s). The document further describes formulations that include pharmaceutical composition forms and physical formats such as liquid, freeze-dried powder, and spray, and additional product configurations include encapsulation and nanoparticle formats.

The described use relates to preventing or treating human coronavirus infections, including SARS-CoV, MERS-CoV, and especially SARS-CoV-2, and also human coronaviruses including HCoV-HKU1, HCoV-NL63, HCoV-OC43, and HCoV-229E. The disclosure ties the approach to antibody-mediated functional effects such as inhibiting ACE2-RBD binding and neutralization activities.

Claims Coverage

The independent claim covers a hyperimmunized egg in which antibody levels to an antigen defined by SEQ ID NO: 19 are increased relative to a non-hyperimmunized egg. The claim family includes six inventive features and extends to product forms, formulation options, and configuration options.

The inventive coverage centers on a hyperimmunized egg containing elevated antibody levels to an antigen defined by SEQ ID NO: 19, further constrained by an antibody titer threshold, and extended to SARS-COV-2-specific egg product forms. The claim family also covers pharmaceutical compositions with specified administration routes and dosage formats, as well as product configurations including encapsulation and nanoparticles with a defined diameter range.

Stated Advantages

Documented Applications