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Publication Number
US-11786458-B2
Publication Date
2023-10-17
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 innate-immune therapeutics for preventing or treating a respiratory condition associated with one or more bacterial infectious agents in a subject by administering to the respiratory tract a composition comprising a TLR2 agonist and a solubilizing agent. The therapeutic approach is based on non-antigen-specific activity using a TLR2 moiety, rather than activity mediated by antigen-directed adaptive immune responses.
A key constraint is that the composition does not contain, nor induce production of, a peptide antigen comprising a T-helper epitope. In this way, humoral immunity and cellular immunity directed against a TLR2 moiety or against the infectious agent or cancer are not the mechanism of treatment.
The composition addresses solubility limitations by combining non-polar TLR2 agonists with solubilizing agents such as polyethylene glycol (PEG) and/or polar polypeptides. The document describes embodiments including PEG-Pam2Cys, together with related Pam2Cys and Pam3Cys compounds, to support innate immune activation in the respiratory tract and associated treatment outcomes.
Claims Coverage
The independent claim set includes one independent method claim directed to preventing or treating a respiratory condition associated with bacterial infectious agents by administering a TLR2 agonist plus a solubilizing agent to the respiratory tract, while excluding a peptide antigen comprising a T-helper epitope. The dependent claims further specify inventive formulation and operational limitations, including particular TLR2 agonist selections and solubilizing agent embodiments, and exclusions of other immune stimulatory agents such as TLR9 agonists.
Respiratory administration of TLR2 agonist and solubilizing agent for prevention or treatment
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.
Defined Pam2Cys/Pam3Cys TLR2 agonist selection
The TLR2 agonist is selected from defined Pam2Cys, Pam3Cys, and related bis-acyloxy propyl cysteine compounds.
Solubilizing agent includes PEG
The solubilizing agent includes polyethyleneglycol (PEG).
PEG-Pam2Cys composition
The composition includes PEG-Pam2Cys.
Exclusion of a TLR9 agonist
A TLR9 agonist is not administered.
Intranasal administration
The composition is administered intranasally to the subject.
Across the independent method framework, the claims focus on delivering a TLR2 agonist together with a solubilizing agent to the respiratory tract for prevention or treatment, while preventing any T-helper epitope peptide antigen from being present or induced. Dependent claims further narrow the invention to specific Pam2Cys/Pam3Cys-related TLR2 agonists, PEG-containing solubilizing agents including PEG-Pam2Cys, and additional exclusions and delivery limitations such as not administering a TLR9 agonist and intranasal administration.
Stated Advantages
Innate activation occurs without treatment being mediated by humoral or cellular immunity directed against the TLR2 moiety or the infectious agent/cancer.
Therapeutic activity is achieved while excluding a peptide antigen comprising a T-helper epitope from the composition and preventing induction of such peptide antigens.
Documented Applications
Preventing or treating a respiratory condition associated with one or more bacterial infectious agents in a subject.
The document further discusses innate-immune therapeutics administered to respiratory sites for influenza A viruses (IAV) and L. pneumophila, including outcomes consistent with innate activation and therapeutic protection.
The document also discusses use for cancer.
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