Immunostimulatory method

Inventors

Jackson, David CharlesTan, AmabelZeng, Weiguang

Assignees

ENA Respiratory Pty Ltd

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Publication Number

US-9676819-B2

Patent

Publication Date

2017-06-13

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 disclosed invention relates to methods for preventing or treating a respiratory condition associated with one or more viral infectious agents in a subject. The method administers to the respiratory tract a composition comprising a soluble TLR2 moiety that includes a TLR2 agonist and a solubilizing agent that increases the solubility of the TLR2 agonist in polar or aqueous solvents.

A central aspect is that the soluble TLR2 moiety raises an innate immune response in the subject while not raising an immune response that is specific for an antigen of the one or more infectious agents. The composition does not contain a peptide antigen comprising a T-helper epitope, and the TLR2 agonist is a lipopeptide.

The disclosed compositions and methods are framed to provide prophylactic or therapeutic effectiveness in respiratory viral settings. In embodiments, the approach omits a TLR9 agonist and focuses on TLR2-driven innate immune effects.

Claims Coverage

The independent claim covers a method for preventing or treating a respiratory condition associated with one or more viral infectious agents by administering to the respiratory tract a soluble TLR2 moiety composition that raises innate immune responses without eliciting antigen-specific immune responses to infectious-agent antigens; the independent claim includes explicit exclusions of a T-helper epitope peptide antigen and specifies that the TLR2 agonist is a lipopeptide.

Soluble TLR2 moiety with solubilized polar/aqueous TLR2 agonist

A method comprising administering to the respiratory tract a composition comprising a soluble TLR2 moiety comprising a TLR2 agonist and a solubilizing agent that increases the solubility of the TLR2 agonist in polar or aqueous solvents.

Innate immune response without antigen-specific immune response

The moiety raises an innate immune response in the subject and does not raise an immune response that is specific for an antigen of the one or more infectious agents.

Absence of a T-helper epitope peptide antigen

The composition does not contain a peptide antigen comprising a T-helper epitope.

TLR2 agonist is a lipopeptide

Wherein the TLR2 agonist is a lipopeptide.

Overall, the claim set focuses on TLR2-based respiratory treatment using soluble, solubilized lipopeptide TLR2 agonists that elicit innate immune responses while avoiding antigen-specific immune responses through exclusion of T-helper epitope peptide antigens.

Stated Advantages

Prevents or treats a respiratory condition associated with one or more viral infectious agents.

Raises an innate immune response in the subject without raising an immune response that is specific for an antigen of the one or more infectious agents.

Provides efficacy in influenza A settings, including reduction of viral loads and increased survival.

Reduces transmission/contact spread in influenza A models.

Provides protective efficacy including single-dose intranasal protection in influenza A embodiments.

Demonstrates antibacterial activity against Legionella pneumophila, including reduced lung/tracheal bacterial loads.

Documented Applications

Preventing or treating respiratory conditions associated with one or more viral infectious agents, including influenza A (IAV) embodiments.

Prophylactic or therapeutic use in influenza A models, including efficacy against multiple influenza A strains referenced in the provided material.

Reducing contact transmission/spread in influenza A models.

Antibacterial activity application against Legionella pneumophila by reducing lung/tracheal bacterial loads.

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