Vaccine for the prevention of the recurrence HER2/neu expressing cancer
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-038/00
C07K-014/71
A61K-038/19
A61K-038/17
A61K-039/00
출원번호
US-0534550
(2012-06-27)
등록번호
US-8796220
(2014-08-05)
발명자
/ 주소
Peoples, George
Ponniah, Sathibalan
출원인 / 주소
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
대리인 / 주소
Nelson Mullins Riley & Scarborough LLP
인용정보
피인용 횟수 :
1인용 특허 :
10
초록▼
The invention features methods to induce and maintain a protective cytotoxic T-lymphocyte response to a peptide of the HER2/neu oncogene, E75, with the effect of inducing and maintaining protective or therapeutic immunity against breast cancer in a patient in clinical remission. The methods comprise
The invention features methods to induce and maintain a protective cytotoxic T-lymphocyte response to a peptide of the HER2/neu oncogene, E75, with the effect of inducing and maintaining protective or therapeutic immunity against breast cancer in a patient in clinical remission. The methods comprise administering to the patient an effective amount of a vaccine composition comprising a pharmaceutically acceptable carrier, an adjuvant such as recombinant human GM-CSF, and the E75 peptide at an optimized dose and schedule. The methods further comprise administering an annual or semi-annual booster vaccine dose due to declining E75-specific T cell immunity. The invention also features vaccine compositions for use in the methods.
대표청구항▼
1. A method of inducing protective or therapeutic immunity against recurrence of a HER2/neu expressing tumor in a subject, wherein the tumor is characterized as having a fluorescence in situ hybridization (FISH) rating of less than about 2.0 for HER2/neu gene expression, said method comprising admin
1. A method of inducing protective or therapeutic immunity against recurrence of a HER2/neu expressing tumor in a subject, wherein the tumor is characterized as having a fluorescence in situ hybridization (FISH) rating of less than about 2.0 for HER2/neu gene expression, said method comprising administering to the subject an effective amount of a composition comprising a pharmaceutically effective carrier and a peptide having the amino acid sequence SEQ ID NO:2. 2. A method of inducing protective or therapeutic immunity against breast cancer recurrence in a subject having an a fluorescence in situ hybridization (FISH) rating of less than about 2.0 for HER2/neu gene expression, said method comprising administering to the subject an effective amount of a composition comprising a pharmaceutically effective carrier and a peptide having the amino acid sequence SEQ ID NO:2. 3. A method of inducing protective or therapeutic immunity against recurrence of HER2/neu expressing tumor in a subject, wherein the tumor is characterized as a fluorescence in situ hybridization (FISH) rating of less than about 2.0 for HER2/neu gene expression, said method comprising administering to the subject an effective amount of a composition comprising a pharmaceutically effective carrier and a peptide having the amino acid sequence SEQ ID NO:2 or a variant thereof, wherein immunity is established by a statistically significant increase in the presence of CD8+ cells specific for the peptide in peripheral blood mononuclear cells of the subject when compared to pre-vaccine levels. 4. The method of claim 1, wherein the composition is administered by injection or inoculation. 5. The method of claim 4, wherein the injection is an intradermal injection. 6. The method of claim 5, wherein the composition is injected in one or more split doses. 7. The method of claim 6, wherein the injection sites are located about 5 cm apart from each other. 8. The method of claim 1, wherein the composition is administered at least three to six times on a monthly basis until the protective immunity is established. 9. The method of claim 1, further comprising administering to the subject a booster after the primary immunization schedule is completed, the booster comprising an effective amount of a vaccine booster composition comprising a pharmaceutically effective carrier and a peptide having SEQ ID NO:2, or variant thereof. 10. The method of claim 9, wherein the booster composition is administered by injection. 11. The method of claim 10, wherein the injection is an intradermal injection. 12. The method of claim 10, wherein the booster composition is injected in one or more separate doses. 13. The method of claim 12, wherein the injection sites are located about 5 cm apart from each other. 14. The method of claim 9, wherein the booster is administered about every six or more months after the primary immunization schedule is completed. 15. The method of claim 1, wherein the subject is a human. 16. The method of claim 15, wherein the human expresses human leukocyte antigen A2. 17. The method of claim 15, wherein the human expresses human leukocyte antigen A3. 18. The method of claim 1, wherein the composition further comprises an adjuvant. 19. The method of claim 18, wherein the adjuvant is recombinant human granulocyte macrophage-colony stimulating factor. 20. The method of claim 9, wherein the vaccine booster composition further comprises an adjuvant. 21. The method of claim 20, wherein the adjuvant is recombinant human granulocyte macrophage-colony stimulating factor. 22. The method of claim 1, wherein the composition comprises 1mg of the peptide and between about 0.01 to 0.5 mg of human granulocyte macrophage-colony stimulating factor as an adjuvant. 23. The method of claim 1, wherein the composition comprises 1mg of the peptide and about 0.25 mg of human granulocyte macrophage-colony stimulating factor as an adjuvant.
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이 특허에 인용된 특허 (10)
Hudziak Robert Michael ; Shepard H. Michael ; Ullrich Axel,DEX, HER2 extracellular domain.
Cheever, Martin A.; Disis, Mary L., Immune reactivity to HER-2/neu protein for diagnosis and treatment of malignancies in which the HER-2/neu oncogene is associated.
Cheever,Martin A; Disis,Mary L, Immune reactivity to HER-2/neu protein for diagnosis and treatment of malignancies in which the HER-2/neu oncogene is associated.
Cheever Martin A. ; Disis Mary L., Immune reactivity to HER-2/neu protein for diagnosis and treatment of malignancies in which the her-2/neu oncogene is a.
William Soo Hoo, Membrane-bound cytokine compositions comprising GM-CSF or an active fragment thereof and methods of modulating and an immune response using the same.
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