Method for the prophylaxis or treatment of coronavirus infection using an immunomodulator and vaccine compositions comprising the same
Inventors
Hsu, Yu-Shen • KANG, SSU-WEI • Chang, Ming-I
Assignees
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Publication Number
US-11986520-B2
Publication Date
2024-05-21
Expiration Date
Abstract
The present disclosure provides a method for the treatment or prophylaxis of coronavirus infection, comprising administering a therapeutically effective amount of an immunomodulator to a subject in need thereof or at risk of coronavirus infection. A vaccine composition comprising a pharmaceutically effective amount of an immunomodulator is also provided.
Core Innovation
The invention relates to prophylactic and therapeutic use of the immunomodulator LTh(αK), also referred to as LTS61K, for coronavirus infection, including SARS-CoV, MERS-CoV, and especially SARS-CoV-2. The method comprises administering LTh(αK) to a subject in need thereof for treatment or prophylaxis.
A central aspect of the invention is the immunomodulatory mechanism associated with LTh(αK) binding via GM1 on mucosal epithelium, including nasal epithelium. This leads to NF-κB activation with increased IFN-α, followed by dendritic cell activation and downregulation of proinflammatory cytokines, and also induces TGFβ/IL-10-driven regulatory T cell activity.
The approach further supports mucosal IgA class switching to neutralize virus and reduce antibody-dependent enhancement (ADE) risk. It also discloses LTh(αK)-based vaccine compositions combining LTh(αK) with an anti-coronavirus antigen such as SARS-CoV-2 spike or RBD, with example studies described for mucosal vaccination and SARS-CoV-2 infection outcomes in Syrian golden hamsters, including reduced lung histopathology and epithelial IFN-α production.
Claims Coverage
The independent claims cover two variants of the same concept: using LTh(αK) as the sole active immunomodulator for treatment or prophylaxis, and using LTh(αK) as the sole active ingredient in an immunomodulatory composition. Across the provided independent claims, the core inventive content is expressed as a single treatment/prophylaxis framework with 2 independent claims, plus refinements in dependent claim members limited to coronavirus species, multiple administrations, and addition of a coronavirus antigen.
LTh(αK) as sole active ingredient for coronavirus treatment or prophylaxis
A method for treatment or prophylaxis of coronavirus infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of an immunomodulator as the sole active ingredient, wherein the immunomodulator is LTh(αK).
LTh(αK)-containing immunomodulatory composition with sole active ingredient
A method for treatment or prophylaxis of coronavirus infection in a subject in need thereof, comprising administering to the subject an immunomodulatory composition comprising LTh(αK) as the sole active ingredient.
Coronavirus selected as SARS-CoV, MERS-CoV, or SARS-CoV-2
The method wherein the coronavirus is selected from SARS-CoV, MERS-CoV, or SARS-CoV-2.
Multiple administrations of LTh(αK)
The method wherein the immunomodulator is administered multiple times.
Addition of a coronavirus antigen
The method further comprising administering a coronavirus antigen to the subject.
Overall, the claim coverage focuses on treating or prophylaxing coronavirus infection using LTh(αK) while requiring it to be the sole active ingredient in the administered immunomodulator or composition. Dependent refinements specify which coronavirus is targeted, permit multiple administrations, and allow an additional administered coronavirus antigen.
Stated Advantages
Induction of increased IFN-α and dendritic cell activation with downregulation of proinflammatory cytokines.
Induction of TGFβ/IL-10-driven Treg activity.
Mucosal IgA class switching that neutralizes virus and reduces antibody-dependent enhancement (ADE) risk.
Reduced lung histopathology in a Syrian golden hamster SARS-CoV-2 pneumonia model.
Documented Applications
Prophylactic and therapeutic treatment or prophylaxis of coronavirus infection in a subject in need thereof using LTh(αK).
Mucosal delivery and LTh(αK)-adjuvanted intranasal recombinant SARS-CoV-2 RBD vaccination producing serum neutralization and mucosal IgA.
SARS-CoV-2 pneumonia model in Syrian golden hamsters showing reduced lung histopathology with prophylactic and therapeutic dosing and epithelial IFN-α production.
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