Vaccine composition

• US 10,660,947 B2
• Filed: 01/16/2019
• Issued: 05/26/2020
• Est. Priority Date: 02/21/2013
• Status: Active Grant

• Current Assignee: Turnstone Limited Partnership
• Original Assignee: Turnstone Limited Partnership
• Inventors: Stojdl, David F., Bell, John Cameron, Lichty, Brian
• Primary Examiner(s): Foley, Shanon A.
• Assistant Examiner(s): Hill, Myron G
• Application Number:
  US16/249,610
• Publication Number:
  US 20190255160A1
• Time in Patent Office: 496 Days
• Field of Search: None
• CPC Class Codes: A61K 2039/5254 avirulent or attenuated
• CPC Class Codes: A61K 2039/5256 expressing foreign proteins
• 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 2039/572 cytotoxic response
• CPC Class Codes: A61K 2039/585 wherein the target is cancer
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/766 Rhabdovirus, e.g. vesicular stomatitis virus
• CPC Class Codes: A61K 39/0005 Vertebrate antigens from snakes A61K39/38
• CPC Class Codes: A61K 39/0011 Cancer antigens
• CPC Class Codes: A61K 39/001184 Cancer testis antigens, e.g. SSX, BAGE, GAGE or SAGE
• CPC Class Codes: A61K 39/001186 MAGE
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• 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 2319/00 Fusion polypeptide
• CPC Class Codes: C07K 2319/50 containing protease site
• CPC Class Codes: C12N 15/86 Viral vectors
• CPC Class Codes: C12N 2710/10343 viral genome or elements thereof as genetic vector
• CPC Class Codes: C12N 2710/16234 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2710/20034 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2740/15043 : viral genome or elements thereof as genetic vector
• CPC Class Codes: C12N 2760/20223 : Virus like particles [VLP]
• CPC Class Codes: C12N 2760/20232 : Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
• CPC Class Codes: C12N 2760/20242 : virus or viral particle as vehicle, e.g. encapsulating small organic molecule
• CPC Class Codes: C12N 2760/20243 : viral genome or elements thereof as genetic vector
• 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

Abstract

There is described a kit for use in inducing an immune response in a mammal, the kit includes: a first virus that expresses MAGEA3, Human Papilloma Virus E6/E7 fusion protein, human Six-Transmembrane Epithelial Antigen of the Prostate protein, or Cancer Testis Antigen 1, or a variant thereof as an antigenic protein and that is formulated to generate an immunity to the protein or variant thereof in the mammal. The kit also includes a Maraba MG1 virus encoding the same antigen, or a variant of the same antigen. The Maraba MG1 virus is formulated to induce the immune response in the mammal. The first virus is immunologically distinct from the Maraba MG1 virus.

Claims

1. A heterologous prime-boost vaccine for use in inducing an immune response in a mammal comprising:

a first virus comprising a nucleic acid capable of expressing an HPV tumour associated antigen, wherein said first virus is capable of generating immunity to said HPV tumour associated antigen;

a second virus, said second virus being a Vesiculovirus, said second virus comprising a nucleic acid capable of expressing an HPV tumour associated antigen, wherein said second virus is capable of providing a therapeutic oncolytic effect in said mammal;

wherein said first virus is immunologically distinct and physically isolated from said second virus; and

wherein the amino acid sequence of the HPV tumour associated antigen comprises the amino acid sequence of SEQ ID NO. 7.

2. The heterologous prime-boost vaccine of claim 1, wherein said second virus is Maraba MG1.

3. The heterologous prime-boost vaccine of claim 2, wherein the amino acid sequence of the HPV tumour associated antigen consists of the amino acid sequence of SEQ ID NO:

7.

4. The heterologous prime-boost vaccine of claim 3, wherein the amino acid sequence of the HPV tumour associated antigen is encoded by the nucleotide sequence of SEQ ID NO:

8.

5. The heterologous prime-boost vaccine of claim 4, wherein the Maraba MG1 genome includes a reverse complement and RNA version of the nucleotide sequence of SEQ ID NO:

9.

6. The heterologous prime-boost vaccine of claim 1, wherein the amino acid sequence of the HPV tumour associated antigen consists of the amino acid sequence of SEQ ID NO:

7.

7. The heterologous prime-boost vaccine of claim 6, wherein the amino acid sequence of the HPV tumour associated antigen is encoded by the nucleotide sequence of SEQ ID NO:

8.

8. The heterologous prime-boost vaccine of claim 1, wherein said first and second viruses express the same HPV tumour associated antigen.

17. The heterologous prime-boost vaccine of claim 1, wherein said first virus is formulated for intramuscular administration.

18. The heterologous prime-boost vaccine of claim 2, wherein said second virus is formulated for intravenous administration.

19. The heterologous prime-boost vaccine of claim 18, wherein said first virus is formulated for intramuscular administration.

9. An HPV antigenic protein comprising an amino acid sequence that is at least 80% identical to the amino acid sequence of SEQ ID NO:

7.

10. The antigenic protein of claim 9, wherein said antigenic protein comprises an amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO:

7.

11. An isolated viral particle having a nucleic acid comprising a nucleotide sequence capable of encoding the antigenic protein of claim 9.

12. The isolated viral particle of claim 11, wherein the isolated viral particle is a Vesiculovirus particle.

13. The isolated viral particle of claim 12, wherein the isolated Vesiculovirus particle is a Maraba MG1 viral particle.

14. The isolated viral particle of claim 11, wherein said nucleotide sequence encodes a protein comprising an amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO:

7.

15. The isolated viral particle of claim 13, wherein the genome of said viral particle comprises a reverse complement and RNA version of the nucleotide sequence of SEQ ID NO:

9.

16. The isolated viral particle of claim 15, wherein said viral particle capable of expressing an HPV antigen having the amino acid sequence of SEQ ID NO:

7.

20. The antigenic protein of claim 10, wherein said antigenic protein comprises an amino acid sequence that is at least 95% identical to the amino acid sequence of SEQ ID NO:

7.

21. The antigenic protein of claim 20, wherein said antigenic protein comprises the amino acid sequence of SEQ ID NO:

7.

22. The antigenic protein of claim 21, wherein the amino acid sequence of said antigenic protein consists of the amino acid sequence of SEQ ID NO:

7.

23. The antigenic protein of claim 21, wherein said antigenic protein is encoded by the nucleotide sequence of SEQ ID NO:

8.

24. The isolated viral particle of claim 14, wherein said nucleotide sequence encodes a protein comprising an amino acid sequence that is at least 95% identical to the amino acid sequence of SEQ ID NO:

7.

25. The isolated viral particle of claim 24, wherein said nucleotide sequence encodes a protein comprising the amino acid sequence of SEQ ID NO:

7.

26. The isolated viral particle of claim 25, wherein said nucleotide sequence encodes a protein whose amino acid sequence consists of the amino acid sequence of SEQ ID NO:

7.

27. The isolated viral particle of claim 25, wherein said nucleotide sequence comprises the nucleotide sequence of SEQ ID NO:

8.