Immunostimulatory method

Inventors

Jackson, David Charles • Tan, Amabel • Zeng, Weiguang

Assignees

ENA Respiratory Pty Ltd

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 immunostimulatory methods that use a soluble TLR2 moiety containing a TLR2 agonist, where the soluble composition is administered to raise non-antigen specific innate immune responses. The approach is described as preventing or treating a respiratory condition associated with one or more infectious agents by using a TLR2 agonist together with a solubilizing agent. The composition is characterized as not containing, and not inducing production of, a peptide antigen comprising a T-helper epitope.

The document describes embodiments for treating or preventing infectious diseases, including influenza A virus and bacterial infections such as Legionella pneumophila, and also indicates use for cancer. It attributes the protective activity to innate immune modulation rather than peptide-antigen directed adaptive immunity, and it frames the method as dependent on soluble presentation of the TLR2 agonist together with the solubilizing agent.

Because the TLR2 agonist is provided as a soluble TLR2 moiety, the document further describes conjugates or combinations that solubilize the agent for aqueous or polar administration, including PEG and polar polypeptides R4, H4, E8, and H8, alone or in combination. The document reports that administration routes include intranasal dosing in respiratory models and describes experimental findings showing expanded pulmonary cell populations and altered innate cytokine responses, along with reductions in viral load and morbidity/mortality in influenza challenge models.

Claims Coverage

The independent claim recites a respiratory treatment/prevention method using a TLR2 agonist plus a solubilizing agent, with an exclusion requirement for T-helper epitope peptide antigen. The inventive features focus on respiratory tract administration, formulation composition, and exclusion of T-helper epitope peptide antigen production, while dependent claims narrow solubilizing-agent options, specific TLR2 agonists, infectious agent category, and specific viral target.

Overall, the claims cover respiratory-tract administration of a composition containing a TLR2 agonist with a solubilizing agent, explicitly requiring that the composition neither contains nor induces production of a peptide antigen comprising a T-helper epitope. Dependent claims further specify particular Cys-based TLR2 agonists, polar-polypeptide solubilizing options (R4/H4/E8/H8), and define the infectious agent category as virus, including influenza A virus.

Stated Advantages

Documented Applications