Nanoparticle compositions

• US 9,539,217 B2
• Filed: 04/03/2014
• Issued: 01/10/2017
• Est. Priority Date: 04/03/2013
• Status: Active Grant

• Current Assignee: N-Fold LLC
• Original Assignee: Allertein Therapeutics, LLC
• Inventors: Sosin, Howard, Caplan, Michael, Fahmy, Tarek
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): TRUONG, QUANGLONG N
• Application Number:
  US14/782,285
• Publication Number:
  US 20160113881A1
• Time in Patent Office: 1,013 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/5258 Virus-like particles
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• 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 2039/55511 Organic adjuvants
• CPC Class Codes: A61K 2039/55516 Proteins; Peptides
• 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 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• 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 2039/577 tolerising response
• CPC Class Codes: A61K 39/025 Enterobacteriales, e.g. Enterobacter
• CPC Class Codes: A61K 39/0258 Escherichia
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 39/35 Allergens
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61K 9/5031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/5153 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/5176 Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/5123
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: C12N 2760/16034 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 7/00 : Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention provides, among other things, nanoparticle compositions including a plurality of nanoparticles, each of which is comprised of a biodegradable or biocompatible polymer arranged in a nanoparticle structure defining an internal lumen and an external surface and one or more of a preparation of hydrophilic cellular components and a preparation of hydrophobic cellular components. In some embodiments, the preparation of hydrophilic cellular components is encapsulated within the internal lumen and the preparation of hydrophobic cellular components is associated with the external surface. Various methods of making and using disclosed nanoparticle compositions are also provided.

Claims

1. A nanoparticle composition comprising:

a plurality of nanoparticles, each of which is comprised of a biodegradable or biocompatible polymer arranged in a nanoparticle structure whose external surface is coated with a preparation comprising a crude hydrophobic bacterial extract and a hydrophilic antigen encapsulated by the nanoparticle structure so that, when the nanoparticle composition is administered to a subject, the antigen is hidden from immune system components.

2. The nanoparticle composition of claim 1, wherein the nanoparticles each also comprise a preparation comprising one or more hydrophilic cellular components.

3. The nanoparticle composition of claim 1, wherein the nanoparticles each further comprise a second antigen, optionally also encapsulated by the nanoparticle structure so that, when the nanoparticle composition is administered to a subject, the antigen is hidden from immune system components.

4. The nanoparticle composition of claim 1, wherein the antigen is selected from the group consisting of an allergic antigen, an anaphylactic antigen, an infectious antigen, an autoantigen, a disease-associated antigen, a food antigen, a microbial antigen, a viral antigen, a tumor antigen, and an environmental antigen.

5. The nanoparticle composition of claim 1, wherein the biodegradable or biocompatible polymer is poly(lactic-co-glycolic acid).

15. The composition of claim 2, wherein the crude hydrophobic bacterial extract of a cellular preparation further comprises immunological components present in absolute or relative amounts as compared to those found in natural microbial cells.

16. The composition of claim 2 or 4, wherein the antigen is provided as a crude hydrophilic extract of a biological source.

17. The composition of claim 2, wherein the preparation comprises a crude hydrophilic cellular extract.

18. The composition of claim 17, wherein the crude hydrophilic cellular extract comprises or consists of an aqueous cellular extract.

19. The composition of claim 18, wherein the cellular extract is a microbial extract.

20. The composition of claim 3, wherein the second antigen is optionally an allergic antigen, an anaphylactic antigen, an infection antigen, an autoantigen, or a disease-associated antigen.

6. A method comprising administering to a human subject in need thereof a nanoparticle composition comprising:

a plurality of nanoparticles, each of which is comprised of a biodegradable or biocompatible polymer arranged in a nanoparticle structure whose external surface is coated with a preparation comprising a crude hydrophobic bacterial extract; and

a hydrophilic antigen encapsulated by the nanoparticle structure so that, when the nanoparticle composition is administered to the human subject, the antigen is hidden from immune system components.

7. The method of claim 6, wherein the antigen is selected from the group consisting of an allergic antigen, an anaphylactic antigen, an infectious antigen, an autoantigen, a disease-associated antigen, a food antigen, a microbial antigen, a viral antigen, a tumor antigen, and an environmental antigen.

8. The method of claim 6, wherein the nanoparticles each further comprise a second antigen, optionally also encapsulated by the nanoparticle structure so that, when the nanoparticle composition is administered to a subject, the antigen is hidden from immune system components.

9. The method of claim 6, wherein the subject is suffering from at least one of allergy, infection, and cancer.

10. The method of claim 6, wherein the nanoparticle is administered intravenously, intradermally, transdermally, orally, subcutaneously, and/or transmucosally.

11. A method of forming a nanoparticle composition comprising:

providing a hydrophilic preparation comprising an antigen;

providing a biodegradable or biocompatible polymer;

associating the hydrophilic preparation with the biodegradable or biocompatible polymer so that nanoparticles comprising the polymer and the preparation are formed; and

coating the nanoparticles with a crude hydrophobic bacterial extract.

12. The method of claim 11, wherein the nanoparticle composition further comprises an antigen.

13. The method of claim 12, wherein the antigen is selected from the group consisting of an allergic antigen, an anaphylactic antigen, an infectious antigen, an autoantigen, a disease-associated antigen, a food antigen, a microbial antigen, a viral antigen, a tumor antigen, and an environmental antigen.

14. The method of claim 12, wherein the nanoparticles each further comprise a second antigen, optionally also encapsulated by the nanoparticle structure so that, when the nanoparticle composition is administered to a subject, the antigen is hidden from immune system components.