Nanoparticles for treatment of allergy

• US 9,597,385 B2
• Filed: 04/23/2013
• Issued: 03/21/2017
• Est. Priority Date: 04/23/2012
• Status: Active Grant

• Current Assignee: N-Fold LLC
• Original Assignee: Allertein Therapeutics, LLC
• Inventors: Caplan, Michael J.
• Primary Examiner(s): GRASER, JENNIFER E
• Application Number:
  US14/390,365
• Publication Number:
  US 20150174225A1
• Time in Patent Office: 1,428 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/542 oral/gastrointestinal
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/55561 CpG containing adjuvants; Oligonucleotide containing adjuvants
• CPC Class Codes: A61K 2039/55572 Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
• CPC Class Codes: A61K 2039/55594 from bacteria
• CPC Class Codes: A61K 2039/57 characterised by the type of response, e.g. Th1, Th2
• CPC Class Codes: A61K 2039/58 raising an immune response against a target which is not the antigen used for immunisation
• CPC Class Codes: A61K 2039/6093 Synthetic polymers, e.g. polyethyleneglycol [PEG], Polymers or copolymers of (D) glutamate and (D) lysine
• CPC Class Codes: A61K 39/001 Preparations to induce tolerance to non-self, e.g. prior to transplantation
• CPC Class Codes: A61K 39/02 Bacterial antigens
• CPC Class Codes: A61K 9/16 Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51

Abstract

The present invention encompasses the surprising finding that nanoparticle compositions can have beneficial effects on allergy even when prepared without a known specific allergy therapeutic. The present invention provides such nanoparticle compositions. In some embodiments, provided nanoparticles are associated with functional elements that cause the nanoparticles to mimic bacterial cells. The present invention encompasses the surprising finding that provided nanoparticles may be useful for treatment and/or prevention of multiple different allergies in a single patient. The present invention encompasses the recognition that provided empty nanoparticles may be useful as a “pan-allergy” therapeutic and/or vaccine.

Claims

1. A method of treating allergy, the method comprising:

administering a pharmaceutical composition to a subject suffering from or susceptible to allergic reaction to a particular allergen, such that at least one of the subject'"'"'s symptoms of allergy are reduced or delayed, wherein;

(i) the pharmaceutical composition comprises a population of nanoparticles formed from at least one polymer, which nanoparticles comprise at least one microbial mimic entity,

wherein the at least one microbial mimic entity is a pathogen-associated molecular pattern (PAMP);

(ii) the pharmaceutical composition is substantially free of the particular allergen; and

(iii) the pharmaceutical composition is formulated for delivery to the subject, and

wherein the administering does not also comprise administering the particular allergen.

2. The method of claim 1, wherein the step of administering is performed via a mode of administration selected from the group consisting of oral (PO), intravenous (IV), intramuscular (IM), intra-arterial, intramedullary, intrathecal, subcutaneous (SQ), intraventricular, transdermal, interdermal, intradermal, rectal (PR), vaginal, intraperitoneal (IP), intragastric (IG), topical, transdermal, mucosal, intranasal, buccal, enteral, vitreal, sublingual administration, by intratracheal instillation, by bronchial instillation, and by inhalation.

3. The method of claim 1, wherein the step of administering comprises administering multiple individual doses to the subject over a specified period of time.

4. The method of claim 1, wherein the at least one polymer is PLGA.

5. The method of claim 1, wherein the PAMP comprises at least one entity associated with an outer surface of a bacterial cell.

6. The method of claim 5, wherein the at least one entity associated with the outer surface of a bacterial cell is selected from the group consisting of:

bacterial lipopolysaccharide, bacterial flagellin, lipoteichoic acid from gram positive bacteria, diacyllipopeptides, triacyllipopeptides, lipopeptide Pam3CysSK4, zymosan from yeast cell wall, peptidoglycans, double-stranded RNAs, unmethylated CpG motifs, heat shock proteins, taxol, viral double-stranded RNA, viral single-stranded RNA, double-stranded DNA, haemozoin, characteristic portions thereof, and/or combinations thereof.

7. The method of claim 5, wherein the at least one entity associated with the outer surface of a bacterial cell is selected from the group consisting of:

bacterial lipopolysaccharide, bacterial flagellin, lipoteichoic acid from gram positive bacteria, peptidoglycan, double-stranded RNAs, unmethylated CpG motifs, any TLR ligands listed in Table 1, characteristic portions thereof, and/or combinations thereof.