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

• US 7,807,146 B2
• Filed: 10/05/2007
• Issued: 10/05/2010
• Est. Priority Date: 10/06/2006
• Status: Active Grant

• Current Assignee: Bavarian Nordic A/S
• Original Assignee: BN Immunotherapeutics, Inc. (Bavarian Nordic A/S)
• Inventors: Delcayre, Alain, Mandl, Stefanie, Laus, Reiner
• Primary Examiner(s): Crouch; Deborah
• Application Number:
  US11/905,876
• Publication Number:
  US 20080213302A1
• Time in Patent Office: 1,096 Days
• Field of Search: None
• US Class Current: 424/93.2
• CPC Class Codes: A61K 2039/55544 Bacterial toxins
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• 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 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 39/001106 Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ErbB4
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C12N 2710/24143 viral genome or elements thereof as genetic vector
• CPC Class Codes: C12N 2830/60 from viruses
• 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 compositions, kits, and methods for cancer therapy using recombinant MVA viruses encoding a tumor-associated antigen, such as HER-2, particularly in combination with taxanes. The taxanes can be administered prior to, at the same time as, or after the recombinant MVA virus.

Claims

1. A method for treating a human cancer patient comprising:

(a) administering to the patient a recombinant MVA expressing a polypeptide comprising a HER-2 antigen; and

(b) administering to the patient a tumoricidal dose of a taxane,

wherein administration of the MVA and the taxane in combination is superior to either treatment alone to inhibit tumor growth.

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 1, wherein the recombinant MVA is administered prior to the tumoricidal dose of the taxane.

5. The method of claim 1, wherein the recombinant MVA is administered at the same time as the tumoricidal dose of the taxane.

6. The method of claim 1, wherein the recombinant MVA is administered after the tumoricidal dose of the taxane.

7. The method of claim 4, wherein the taxane is docetaxel.

8. The method of claim 4, wherein the taxane is paclitaxel.

9. The method of claim 6, wherein the taxane is docetaxel.

10. The method of claim 6, wherein the taxane is paclitaxel.

11. The method of claim 7, wherein the taxane is docetaxel at a dose of 75-100 mg/m².

12. The method of claim 8, wherein the taxane is paclitaxel at a dose of 135-175 mg/m².

13. The method of claim 9, wherein the taxane is docetaxel at a dose of 75-100 mg/m².

14. The method of claim 10, wherein the taxane is paclitaxel at a dose of 135-175 mg/m².

15. The method of claim 4, wherein the recombinant MVA is administered 1-26 weeks prior to the tumoricidal dose of the taxane.

16. The method of claim 4, wherein the recombinant MVA is administered 1-3 weeks prior to the tumoricidal dose of the taxane.

17. The method of claim 6, wherein the recombinant MVA is administered 2-60 days after the tumoricidal dose of the taxane.

18. The method of claim 6, wherein the recombinant MVA is administered 2-7 days after the tumoricidal dose of the taxane.

19. A kit for treating a cancer patient comprising:

(a) a recombinant MVA expressing a polypeptide comprising a HER-2 antigen; and

(b) instructions to administer the recombinant MVA prior to treatment with a tumoricidal dose of a taxane,

wherein administration of the MVA and the taxane in combination is superior to either treatment alone to inhibit tumor growth.

22. The kit of claim 19, wherein the HER-2 antigen comprises SEQ ID NO:

2.

20. A kit for treating a cancer patient comprising:

(a) a recombinant MVA expressing a polypeptide comprising a HER-2 antigen; and

(b) instructions to administer the recombinant MVA at the same time as treatment with a tumoricidal dose of a taxane,

wherein administration of the MVA and the taxane in combination is superior to either treatment alone to inhibit tumor growth.

23. The kit of claim 20, wherein the HER-2 antigen comprises SEQ ID NO:

2.

21. A kit for treating a cancer patient comprising:

(a) a recombinant MVA expressing a polypeptide comprising a HER-2 antigen; and

(b) instructions to administer the recombinant MVA after treatment with a tumoricidal dose of a taxane,

wherein administration of the MVA and the taxane in combination is superior to either treatment alone to inhibit tumor growth.

24. The kit of claim 21, wherein the HER-2 antigen comprises SEQ ID NO:

2.

25. A recombinant vaccinia virus expressing a polypeptide comprising a HER-2 antigen,

wherein the HER-2 antigen comprises SEQ ID NO:

2, and

wherein administration of the MVA and a tumoricidal dose of a taxane in combination is superior to either treatment alone to inhibit tumor growth.