Methods for treating cancer with a recombinant MVA expressing HER-2

1. A method for stimulating the formation of antibodies which are capable of binding to human HER-2 expressed on the surface of cells comprising providing a recombinant MVA encoding a polypeptide comprising a human HER-2 antigen for administration to a human cancer patient; wherein the administration stimulates the formation of antibodies which are capable of binding to human HER-2 expressed on the surface of cells; and wherein the antibodies produce a measurable reduction in tumor size or tumor mass compared to patients not administered the recombinant MVA encoding a polypeptide comprising a human HER-2 antigen.

2. The method of claim 1 , wherein the MVA is MVA-BN.

3. The method of claim 1 , wherein the HER-2 antigen comprises SEQ ID NO:2.

4. The method of claim 2 , wherein the HER-2 antigen comprises SEQ ID NO:2.

5. The method of claim 1 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

6. The method of claim 2 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

7. The method of claim 3 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

8. The method of claim 4 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

9. The method of claim 1 , wherein the human cancer patient is a breast cancer patient.

10. The method of claim 2 , wherein the human cancer patient is a breast cancer patient.

11. The method of claim 3 , wherein the human cancer patient is a breast cancer patient.

12. The method of claim 4 , wherein the human cancer patient is a breast cancer patient.

13. The method of claim 5 , wherein the human cancer patient is a breast cancer patient.

14. The method of claim 1 , wherein the administration induces T-cells that react with epitopes present in the native HER-2 protein.

15. A method for inducing T-cells that react with epitopes present in the native HER-2 protein comprising providing a recombinant MVA encoding a polypeptide comprising a HER-2 antigen for administration to a human cancer patient; wherein the administration induces T-cells that react with epitopes present in the native HER-2 protein; and wherein the T-cells produce a measurable reduction in tumor size or tumor mass compared to patients not administered the recombinant MVA encoding a polypeptide comprising a human HER-2 antigen.

16. The method of claim 15 , wherein the MVA is MVA-BN.

17. The method of claim 15 , wherein the HER-2 antigen comprises SEQ ID NO:2.

18. The method of claim 16 , wherein the HER-2 antigen comprises SEQ ID NO:2.

19. The method of claim 15 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

20. The method of claim 16 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

21. The method of claim 17 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

22. The method of claim 18 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

23. The method of claim 15 , wherein the human cancer patient is a breast cancer patient.

24. The method of claim 16 , wherein the human cancer patient is a breast cancer patient.

25. The method of claim 17 , wherein the human cancer patient is a breast cancer patient.

26. The method of claim 18 , wherein the human cancer patient is a breast cancer patient.

27. The method of claim 19 , wherein the human cancer patient is a breast cancer patient.

28. The method of claim 15 , wherein the administration induces antibodies which are capable of binding to human HER-2 expressed on the surface of cells.

29. A method for stimulating the formation of antibodies which are capable of binding to human HER-2 expressed on the surface of cells comprising providing a recombinant MVA encoding a polypeptide comprising a human HER-2 antigen for administration to a human cancer patient; wherein the administration stimulates the formation of antibodies which are capable of binding to human HER-2 expressed on the surface of cells; and wherein the ratio of immunoglobulin isotype G2a (IgG2a) antibodies to immunoglobulin isotype G1 (IgG1) antibodies is measurably higher in patients administered the recombinant MVA encoding a polypeptide comprising a human HER-2 antigen compared to patients not administered the recombinant MVA encoding a polypeptide comprising a human HER-2 antigen.

30. The method of claim 29 , wherein the MVA is MVA-BN.

31. The method of claim 29 , wherein the HER-2 antigen comprises SEQ ID NO:2.

32. The method of claim 30 , wherein the HER-2 antigen comprises SEQ ID NO:2.

33. The method of claim 29 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

34. The method of claim 30 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

35. The method of claim 31 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

36. The method of claim 32 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

37. The method of claim 29 , wherein the human cancer patient is a breast cancer patient.

38. The method of claim 30 , wherein the human cancer patient is a breast cancer patient.

39. The method of claim 31 , wherein the human cancer patient is a breast cancer patient.

40. The method of claim 32 , wherein the human cancer patient is a breast cancer patient.

41. The method of claim 33 , wherein the human cancer patient is a breast cancer patient.

42. The method of claim 29 , wherein the administration induces T-cells that react with epitopes present in the native HER-2 protein.

43. A method for inducing T-cells that react with epitopes present in the native HER-2 protein comprising providing a recombinant MVA encoding a polypeptide comprising a HER-2 antigen for administration to a human cancer patient; wherein the administration induces T-cells that react with epitopes present in the native HER-2 protein; wherein the T-cells are predominantly T H 1 T-cells as determined by comparing the ratio of IgG2a to IgG1 antibodies in patients administered the recombinant MVA encoding a polypeptide expressing a HER-2 antigen to the ratio of IgG2a to IgG1 antibodies in patients not administered the recombinant MVA encoding a polypeptide comprising a human HER-2 antigen; and wherein a measurably higher ratio of IgG2a to IgG1 antibodies after administration of the HER-2 antigen indicates a predominantly T H 1 T-cell response.

44. The method of claim 43 , wherein the MVA is MVA-BN.

45. The method of claim 43 , wherein the HER-2 antigen comprises SEQ ID NO:2.

46. The method of claim 44 , wherein the HER-2 antigen comprises SEQ ID NO:2.

47. The method of claim 43 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

48. The method of claim 44 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

49. The method of claim 45 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

50. The method of claim 46 , further comprising administering a tumoricidal dose of docetaxel to the human cancer patient.

51. The method of claim 43 , wherein the human cancer patient is a breast cancer patient.

52. The method of claim 44 , wherein the human cancer patient is a breast cancer patient.

53. The method of claim 45 , wherein the human cancer patient is a breast cancer patient.

54. The method of claim 46 , wherein the human cancer patient is a breast cancer patient.

55. The method of claim 47 , wherein the human cancer patient is a breast cancer patient.

56. The method of claim 43 , wherein the administration induces antibodies which are capable of binding to human HER-2 expressed on the surface of cells.