Immunostimulatory oligonucleotides

• US 9,453,059 B2
• Filed: 06/28/2013
• Issued: 09/27/2016
• Est. Priority Date: 12/09/2008
• Status: Active Grant

• Current Assignee: Coley Pharmaceutical Group, Inc. (Pfizer Inc.)
• Original Assignee: Coley Pharmaceutical Group, Inc. (Pfizer Inc.)
• Inventors: Davis, Heather, Weeratna, Risini
• Primary Examiner(s): Minnifield, Nita M
• Application Number:
  US13/930,213
• Publication Number:
  US 20150086610A1
• Time in Patent Office: 1,187 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/55561 CpG containing adjuvants; Oligonucleotide containing adjuvants
• CPC Class Codes: A61K 2039/57 characterised by the type of response, e.g. Th1, Th2
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/001104 Epidermal growth factor receptors [EGFR]
• CPC Class Codes: A61K 39/001106 Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ErbB4
• CPC Class Codes: A61K 39/001182 Carcinoembryonic antigen [CEA]
• CPC Class Codes: A61K 39/001186 MAGE
• CPC Class Codes: A61K 39/001188 NY-ESO
• CPC Class Codes: A61K 39/001194 Prostate specific antigen [PSA]
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/292 Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 14/005 from viruses
• CPC Class Codes: C07K 14/31 from Staphylococcus (G)
• CPC Class Codes: C07K 14/47 from mammals
• CPC Class Codes: C12N 2710/16634 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2730/10134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2740/16034 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/18534 : 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 invention relates to immunostimulatory oligonucleotides and methods of using immunostimulatory oligonucleotides to induce an antigen-specific immune response. The invention further relates to a vaccine that comprises an immunostimulatory oligonucleotide and an antigen, and comprises a pharmaceutically acceptable carrier. The immunostimulatory oligonucleotides of the invention, in some embodiments, include one or more modified linkage(s).

Claims

1. A composition comprising an antigen and an immunostimulatory oligonucleotide comprising the nucleotide sequence of SEQ ID NO:

1, and further comprising a pharmaceutically acceptable carrier.

2. The composition of claim 1, wherein the immunostimulatory oligonucleotide is in an effective amount to induce an antigen-specific immune response.

3. The composition of claim 2, wherein the antigen-specific immune response induced is a Th1 immune response.

4. The composition of claim 1, wherein the antigen is a microbial antigen, a self antigen or an addictive substance.

5. The composition of claim 4, wherein the microbial antigen is a bacterial antigen, a viral antigen or a parasitic antigen.

6. The composition of claim 5, wherein the bacterial antigen is associated with Staphylococcus aureus.

7. The composition of claim 5, wherein the viral antigen is associated with Respiratory Syncytial virus (RSV), Herpes Simplex virus 1, Herpes Simplex virus 2, Human Immunodeficiency Virus-1 (HIV-1) or HIV-2.

8. The composition of claim 4, wherein the self antigen is a tumor antigen, an antigen associated with Alzheimer'"'"'s Disease, an antigen against a human antibody, or an antigen that is expressed from human endogenous retroviral elements.

9. The composition of claim 8, wherein the tumor antigen is HER2, MAGE, NY-ESO, PSA, CEA or a variant form of EGFR.

10. The composition of claim 8, wherein the antigen is IgE.

11. The composition of claim 4, wherein the antigen is a nicotine hapten conjugated to a carrier.

12. The composition of claim 11, wherein the carrier to which the nicotine hapten is conjugated is diphtheria toxin (DT).

13. The composition of claim 1, wherein the antigen is a peptide, a recombinant protein, a purified protein, whole killed pathogen, live attenuated virus or viral vector, live attenuated bacteria or a bacterial vector, a polysaccharide, a hapten, or encoded by plasmid DNA.

14. The composition of claim 1, wherein the antigen is conjugated to a carrier.

15. The composition of claim 14, wherein the carrier is diphtheria toxin (DT) or a virus-like particle.

16. The composition of claim 15, wherein the virus-like particle is RNA phage Q-β

, hepatitis B surface antigen (HBsAg), or hepatitis B core antigen (HbcAg).

17. The composition of claim 1, further comprising one or more adjuvants.

18. The composition of claim 17, wherein the adjuvant is an aluminum salt.

19. The composition of claim 18, wherein the aluminum salt is aluminum hydroxide.

20. The composition of claim 17, wherein the adjuvant is a liposome.

21. The composition of claim 1, wherein the immunostimulatory oligonucleotide comprises one or more phosphorothioate linkages.

22. The composition of claim 1, wherein the immunostimulatory oligonucleotide comprises at least one lipophilic substituted nucleotide analog and a pyrimidine-purine dinucleotide.

23. The composition of claim 1, wherein the composition is formulated for administration via a parenteral route, wherein the parenteral route is intramuscular, subcutaneous, intradermal, intravenous or intraperitoneal.

24. The composition of claim 1, wherein the composition is formulated for administration via a topical route, wherein the topical route is the skin, transdermal or a mucosal surface.