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Publication Number
US-11351114-B2
Publication Date
2022-06-07
Expiration Date
Abstract
This invention relates to a method for treating or preventing a disease by raising an innate immune response in a subject, the method comprising administering to the subject an effective amount of a composition comprising a TLR2 moiety in solution, wherein the TLR2 moiety comprises a TLR2 agonist and wherein the disease is not treated or prevented by a humoral or cellular immune response directed against the TLR2 moiety.
Core Innovation
The invention relates to an immunostimulatory therapy for preventing or treating a respiratory condition associated with one or more viral infectious agents. The therapy administers to the respiratory tract a composition comprising a TLR2 agonist together with a solubilizing agent, and is configured to prevent or treat the respiratory condition by raising innate immune responses associated with TLR2 stimulation.
A key feature is that the composition does not contain, and does not induce production of, a peptide antigen comprising a T-helper epitope. This design is intended to avoid humoral/cellular immunity directed against the TLR2 moiety while still providing innate immune activation. The approach is described as non-antigen-specific antiviral activity rather than immunity focused on a T-helper epitope.
The disclosed subject-matter further emphasizes administration to the respiratory tract, including intranasal administration in dependent claim context, for respiratory viral infectious agents. The described effects include expanded pulmonary innate cell populations and reduced viral loads and/or survival benefits in influenza A virus models, and protection is described as not relying on IFN-gamma or type I interferon signaling.
Claims Coverage
One independent claim recites a method for preventing or treating a respiratory condition associated with viral infectious agents by administering a composition to the respiratory tract with specific content exclusions regarding T-helper epitopes. The claim set contains dependent claims that refine the solubilizing agent, specify named TLR2 agonist formulations, narrow administration route, and characterize the infectious-agent context as viral.
Administering a respiratory-tract TLR2 agonist with a solubilizing agent
A method comprising administering to the respiratory tract a composition comprising a TLR2 agonist and a solubilizing agent, thereby preventing or treating the respiratory condition in the subject.
No T-helper epitope peptide antigen present or induced
The composition does not contain, nor induce production of, a peptide antigen comprising a T-helper epitope.
PEG plus a selected polar polypeptide solubilizing agent
The solubilizing agent includes polyethyleneglycol (PEG) and one selected from K4, R4, H4, E8, branched E8, and H8.
PEG-Pam2Cys composition
The composition includes PEG-Pam2Cys.
Pam2CysSK4 composition
The composition comprises Pam2CysSK4.
Intranasal administration
The composition is administered intranasally to a subject.
Viral infectious-agent associated condition
The condition is associated with an infectious agent in the form of a virus.
Across the independent claim and refinements reflected by dependent claims, the inventive core is respiratory-tract administration of a TLR2 agonist with a solubilizing agent, combined with an explicit exclusion of peptide antigen comprising a T-helper epitope. Dependent refinements specify PEG-based solubilizing constructs, including PEG-Pam2Cys, Pam2CysSK4, and PEG with selected polar polypeptide variants, and narrow delivery to intranasal administration for virus-associated respiratory conditions.
Stated Advantages
Prevents or treats a respiratory condition associated with one or more viral infectious agents.
Raises innate immune responses associated with TLR2 stimulation while avoiding peptide antigen-driven T-helper epitope immunity.
Provides non-antigen-specific antiviral activity as described in the document.
Does not rely on IFN-gamma or type I interferon signaling as described in the document.
Documented Applications
Prophylaxis and therapeutic treatment of respiratory conditions associated with viral infectious agents, with emphasis on influenza A virus.
Prophylaxis and therapeutic treatment of respiratory conditions associated with viral infectious agents, with emphasis on Legionella pneumophila in a bacterial challenge context as described in the document.
Intranasal administration to expand pulmonary innate cell populations as described in the document.
Use in influenza A virus models showing reduced viral loads and/or survival benefits as described in the document.
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