COMPOSITIONS COMPRISING AN ANTIGEN, AN AMPHIPATHIC COMPOUND AND A HYDROPHOBIC CARRIER, AND USES THEREOF

• US 20100209452A1
• Filed: 10/02/2008
• Published: 08/19/2010
• Est. Priority Date: 10/03/2007
• Status: Abandoned Application

• Current Assignee: Immunovaccine Technologies, Inc.
• Original Assignee: Immunovaccine Technologies, Inc.
• Inventors: Mansour, Marc
• Application Number:
  US12/679,998
• Publication Number:
  US 20100209452A1
• Time in Patent Office: Days
• US Class Current: 424/204.100
• CPC Class Codes: A61K 2039/55511 Organic adjuvants
• 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 2039/605 MHC molecules or ligands thereof
• CPC Class Codes: A61K 39/0011 Cancer antigens
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61P 37/04 Immunostimulants

Abstract

The present invention provides compositions comprising an antigen, an amphipathic compound, and a hydrophobic carrier and methods of using these compositions for inducing an antibody or cell-mediated response in a subject.

Claims

1. A composition comprising:

an antigen;

an amphipathic compound; and

a hydrophobic carrier;

wherein the composition is substantially free of water.

2. The composition according to claim 1, comprising less than 10% water by weight, based on the total weight of the composition.

3. The composition according to claim 1, wherein less than 20% of the antigen (by weight) is suspended in water.

4. The composition according to claim 1, wherein the hydrophobic carrier comprises an emulsifier.

5. The composition according to claim 1, wherein said amphipathic compound comprises a phospholipid.

6. The composition according to claim 1, wherein said amphipathic compound is lecithin.

7. The composition according to claim 1, wherein said hydrophobic carrier comprises an oil or a mixture of oils.

8. The composition according to claim 4, wherein said emulsifier comprises Span80, mannide oleate or a mixture thereof.

9. The composition according to claim 1, wherein said antigen comprises:

a polypeptide, a polynucleotide encoding a polypeptide, a peptide, a live bacterium, a killed bacterium, a live virus, an attenuated virus, an inactivated bacterium, or a part thereof.

10. The composition according to claim 1, further comprising an adjuvant.

11. The composition according to claim 1, comprising about 0.1 to about 250 mg of the amphipathic compound per ml of the composition.

12. The composition according to claim 4, wherein the hydrophobic carrier comprises about 5% to about 15% by weight of the emulsifier.

13. The composition according to claim 1, wherein said antigen and said amphipathic compound are provided as a dry mixture in a first container, and said hydrophobic carrier and emulsifier are provided in a second container.

14. A process for making the composition according to claim 1, the process comprising:

(a) combining an antigen and an amphipathic compound to form a dry mixture; and

(b) suspending said mixture in a hydrophobic carrier.

15. The process according to claim 14, further comprising adding an adjuvant to the composition.

16. The process according to claim 14, wherein said hydrophobic carrier comprises an emulsifier.

17. The process according to claim 14, wherein said combining step comprises:

solubilizing said antigen;

solubilizing said amphipathic compound;

combining said solubilized antigen and said solubilized amphipathic compound to form a mixture; and

drying said mixture.

18. The process according to claim 14, wherein said combining step comprises dry milling said antigen with said amphipathic compound.

19. A method comprising administering the composition according to claim 1 to a subject.

20. A method for inducing an antibody response or cell-mediated immune response in a subject, said method comprising administering to a subject in need thereof the composition according to claim 1.

21. The method of claim 19, wherein the composition is administered orally, nasally, rectally or parenterally