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1. WO2015114575 - TOLEROGENIC COMPOSITIONS COMPRISING AND USES THEREOF

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[ EN ]

CLAIMS

1. A polypeptide selected from a Vac A protein, a fragment or a variant thereof or a formulation thereof for use in the prevention and/or treatment of an allergic disorder.

2. A polypeptide for use according to claim 1 wherein the Vac A protein is Vac A protein comprising an amino acid sequence selected from SEQ ID NO: 1, 2, 4, 5, 6, 7,

8, 9, 10 and 11.

3. A polypeptide for use according to claim 1 or 2, wherein the polypeptide is in the form of H. pylori bacteria dead cell extract.

4. A polypeptide for use according to claim 3, wherein the H. pylori bacteria strain is ATCC 49503/30190.

5. A polypeptide for use according to any one of claims 1 to 4, wherein VacA is purified from extracts from non-denaturated killed H. pylori bacteria cells.

6. A polypeptide for use according to any one of claims 2 to 4, wherein the H. pylori bacteria dead cell extract is obtainable by a process comprising the steps of:

(i) harvesting a culture of living bacteria cells;

(ii) submitting the harvested bacteria to several freeze/thaw cycles in water or aqueous solution of a salt;

(iii) disrupting the bacterial cells under high pressure;

(iv) collecting the cell extract.

7. A polypeptide for use according to claim 1 or 2, wherein Vac A is recombinant Vac A.

8. A polypeptide selected from a Vac A protein, a fragment or a variant thereof or a formulation thereof for use in the inducing a tolerization response to an allergen.

9. A polypeptide selected from a Vac A protein, a fragment or a variant thereof or a formulation thereof for use according to any one of claims 1 to 8, wherein the polypeptide selected from a Vac A protein, a fragment or a variant thereof is to be administered in a form essentially free from any immunogenic component.

10. A polypeptide for use according to any one of claims 1 to 9, wherein the allergic disorder is atopic asthma.

11. A polypeptide for use according to any one of claims 1 to 9, wherein the allergic disorder is food allergy.

12. A polypeptide for use according to any one of claims 1 to 11, wherein the composition is to be administered by the oral, intranasal, parenteral, intrapulmonary or systemic route.

13. A pharmaceutical tolerogenic formulation comprising a Vac A protein, a fragment or a variant thereof and at least one pharmaceutically acceptable carrier, diluent or excipient thereof.

14. A pharmaceutical tolerogenic formulation according to claim 13, wherein the said Vac A protein, a fragment or a variant thereof is essentially free from an immunogenic component.

15. A pharmaceutical tolerogenic formulation according to claim 14, wherein the said Vac A protein, a fragment or a variant thereof is essentially pure from other H. pylori antigen components.

16. A pharmaceutical formulation according to any one of claims 13 to 15, wherein the said Vac A protein, a fragment or a variant thereof is combined with at least one co- agent useful in the prevention and/or treatment of an allergic disorder or an allergic response or for inducing a tolerization response to an allergen.

17. A composition according to any one of claims 13 to 16, wherein the composition is an oral pharmaceutical composition.

18. A composition according to any one of claims 13 to 16, wherein the composition is an injectable pharmaceutical composition.

19. A composition according to any one of claims 13 to 18, further comprising an allergen.

20. A composition according to claim 19, wherein the allergen is at least one food allergen or a mixture thereof.

21. A composition for use according to claims 1, wherein the composition is a pharmaceutical composition according to claims 13 or 19.

22. A method of preventing, repressing or treating an allergic response, in particular, an allergic disorder in a subject, said method comprising administering in a subject in need thereof a therapeutically effective amount a polypeptide selected from a Vac A, a fragment or a variant thereof, or a pharmaceutical formulation thereof.

23. A method according to claim 21 wherein the composition is a pharmaceutical composition according to any one of claims 13 to 20.