# US 2014/0193457 A1 · Immunostimulatory oligodeoxynucleotides

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- Number: US 2014/0193457 A1
- Document ID: US20140193457A1
- Status: Published application
- Kind: A1
- Application number: 14/119,492
- Filed: 2012-05-25
- Published: 2014-07-10
- Earliest claimed: 2011-05-26
- Assignees: Intervet International B.V.
- Applicants: Intervet International B.V.
- Inventors: Carla Christina Schrier; Simon ILG
- Web page: https://patentgrep.com/patent/US20140193457A1

## CPC

- C12N 15/117: Nucleic acids having immunomodulatory properties, e.g. containing CpG-motifs
- A61P 31/04: Antibacterial agents
- A61P 31/12: Antivirals
- A61P 33/02: Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- C12N 2310/17: Immunomodulatory nucleic acids
- C12N 2310/315: Phosphorothioates
- C12N 2310/341: Gapmers, i.e. of the type ===---===
- C12N 2310/343: having patterns, e.g. ==--==--==--
- C12N 2310/345: having at least two different backbone modifications
- C12N 2310/3513: Protein; Peptide
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

The present invention relates to immunostimulatory oligodeoxynucleotides, vectors and vaccines comprising such oligodeoxynucleotides, to their use as a medicament, to their use in preventing or combating infectious disease and to methods for the detection of such oligodeoxynucleotides.

## Claims

### Claim 1

1) An immunostimulatory non-methylated oligodeoxynucleotide having the general formula
5′[G]x{TCGTCG}nTCG[G]z3′
wherein
x=3-20;
z=0-10;
n=2-100;
or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

2) An immunostimulatory non-methylated oligodeoxynucleotide according to claim 1, characterised in that
x=3-10;
z<5;
n=3-18;

### Claim 3 (depends on 1)

3) The oligodeoxynucleotide according to claim 1, wherein the 5′[G]x and the 3′[G]z nucleotides have a phosphorothioate binding and the other nucleotides have a phosphodiester binding.

### Claim 4 (depends on 1)

4) The oligodeoxynucleotide according to claim 1, wherein said oligodeoxynucleotide is coupled to a carrier or hapten.

### Claim 5 (depends on 1)

5) A vector comprising the oligodeoxynucleotide according to claim 1.

### Claim 6 (depends on 1)

6) A vaccine for preventing or combating an infectious disease, characterised in that said vaccine comprises an immunostimulatory amount of an oligodeoxynucleotide according to claim 1, an immunogenic amount of an antigen component or genetic information encoding an antigen component, and a pharmaceutically acceptable carrier.

### Claim 7 (depends on 1)

7) A vaccine for preventing or combating an infectious disease, characterised in that said vaccine comprises an immunostimulatory amount of an oligodeoxynucleotide according to claim 1, an immunogenic amount of an antigen component or genetic information encoding an antigen component, and a pharmaceutically acceptable carrier, wherein said antigen component is, or is derived from a virus or micro-organism that in its wild-type form is pathogenic to poultry.

### Claim 8 (depends on 1)

8) A vaccine for preventing or combating an infectious disease, characterised in that said vaccine comprises an immunostimulatory amount of an oligodeoxynucleotide according to claim 1, an immunogenic amount of an antigen component or genetic information encoding an antigen component, and a pharmaceutically acceptable carrier, wherein said antigen component is, or is derived from a virus or micro-organism that in its wild-type form is pathogenic to poultry, and wherein said virus or micro-organism is selected from the group consisting of Infectious Bronchitis virus, Newcastle Disease virus, Infectious Bursal Disease (Gumboro), Chicken Anaemia agent, Avian Reovirus, Mycoplasma gallisepticum, Turkey Rhinotracheitis virus, Haemophilus paragallinarum (Coryza), Chicken Poxvirus, Avian Encephalomyelitis virus, Egg Drop syndrome virus, Infectious Laryngotracheitis virus, Herpesvirus of Turkeys, Eimeria species, Ornithobacterium rhinotracheale, Pasteurella multocida, Mycoplasma synoviae, Salmonella species and E. coli.

### Claim 9 (depends on 1)

9) An immunostimulatory non-methylated oligodeoxynucleotide according to claim 1 for use as a medicament.

### Claim 10 (depends on 1)

10) An immunostimulatory non-methylated oligodeoxynucleotide according to claim 1 for use in preventing or combating infectious disease in poultry.

### Claim 11 (depends on 1)

11) A method for the detection of immunostimulatory oligodeoxynucleotides according to claim 1, characterised in that said method comprises the steps of
a) contacting an oligodeoxynucleotide with a cell comprising a TLR21-receptor and a plasmid encoding an NF-κB reporter gene, which plasmid is stably maintained in the cell, and
b) detecting the level of the product of the reporter gene.

### Claim 12 (depends on 1)

12) A method for the detection of immunostimulatory oligodeoxynucleotides according to claim 1, characterised in that said method comprises the steps of
a) contacting an oligodeoxynucleotide with a cell comprising a TLR21-receptor and a plasmid encoding an NE-κB reporter gene, which plasmid is stably maintained in the cell, and
b) detecting the level of the product of the reporter gene,
wherein the product of the reporter gene is secreted alkaline phosphatase.

### Claim 13 (depends on 1)

13) A method for the detection of immunostimulatory oligodeoxynucleotides according to claim 1, characterised in that said method comprises the steps of
a) contacting an oligodeoxynucleotide with a cell comprising a TLR21-receptor and a plasmid encoding an NF-KB reporter gene, which plasmid is stably maintained in the cell, and
b) detecting the level of the product of the reporter gene, and wherein the cell is a cell of chicken cell line HD11, or a HEK293 cell line into which a chicken TLR21 receptor gene has been cloned.

### Claim 14 (depends on 1)

14) A vaccine for preventing or combating an infectious disease, characterised in that said vaccine comprises a vector comprising the oligodeoxynucleotide according to claim 1, an immunogenic amount of an antigen component or genetic information encoding an antigen component, and a pharmaceutically acceptable carrier.

### Claim 15 (depends on 1)

15) A vaccine for preventing or combating an infectious disease, characterised in that said vaccine comprises a vector comprising the oligodeoxynucleotide according to claim 1, an immunogenic amount of an antigen component or genetic information encoding an antigen component, and a pharmaceutically acceptable carrier, wherein said antigen component is, or is derived from a virus or micro-organism that in its wild-type form is pathogenic to poultry.

### Claim 16 (depends on 1)

16) A vaccine for preventing or combating an infectious disease, characterised in that said vaccine comprises a vector comprising the oligodeoxynucleotide according to claim 1, an immunogenic amount of an antigen component or genetic information encoding an antigen component, and a pharmaceutically acceptable carrier, wherein said antigen component is, or is derived from a virus or micro-organism that in its wild-type form is pathogenic to poultry, and wherein said virus or micro-organism is selected from the group consisting of Infectious Bronchitis virus, Newcastle Disease virus, Infectious Bursal Disease (Gumboro), Chicken Anaemia agent, Avian Reovirus, Mycoplasma gallisepticum, Turkey Rhinotracheitis virus, Haemophilus paragallinarum (Coryza), Chicken Poxvirus, Avian Encephalomyelitis virus, Egg Drop syndrome virus, Infectious Laryngotracheitis virus, Herpesvirus of Turkeys, Eimeria species, Omithobacterium rhinotracheale, Pasteurella multocida, Mycoplasma synoviae, Salmonella species and E. coli.

### Claim 17 (depends on 1)

17) A vector comprising the oligodeoxynucleotide according to claim 1 for use as a medicament.

### Claim 18 (depends on 1)

18) A vector comprising the oligodeoxynucleotide according to claim 1 for use in preventing or combating infectious disease in poultry.