Vaccine therapy for treatment of endometrial and ovarian cancer
View Patent ↗The present invention provides methods of preventing or reducing the risk of recurrence of endometrial and ovarian cancers which express low levels of folate binding protein (FBP) by administration of a vaccine containing an E39 peptide.
1. A method of preventing or reducing a risk of recurrence of ovarian cancer or endometrial cancer in a human subject, which method comprises:
administering to the human subject a peptide vaccine comprising about 1.0 mg of a peptide consisting of the amino acid sequence of SEQ ID NO: 1 and an adjuvant, every 3 to 4 weeks for a period of at least about six months,
wherein the human subject is an HLA-A2+ subject and is in remission following treatment with a standard course of therapy,
wherein the human subject, prior to remission, had ovarian or endometrial cancer cells with low expression of folate receptor-alpha (FRα) or no expression of FRα, wherein low or no expression of FRα is an immunohistochemistry (IHC) rating of 0 or 1 protein expression, and
wherein the method prevents or reduces the risk of recurrence of ovarian cancer or endometrial cancer in the human subject.
2. The method of claim 1 , wherein the peptide vaccine is administered by injection.
3. The method of claim 1 , wherein the peptide vaccine is administered by intradermal injection.
4. The method of claim 3 , wherein the peptide vaccine is administered as split dosages that are administered concurrently.
5. The method of claim 4 , wherein the split dosages are administered at one site or at different sites.
6. The method of claim 5 , wherein the split dosages are administered at least 5 cm apart.
7. The method of claim 1 , wherein the adjuvant is granulocyte macrophage-colony stimulating factor (GM-CSF).
8. The method of claim 7 , wherein the peptide vaccine comprises between about 0.01 mg to about 0.5 mg GM-CSF.
9. The method of claim 7 , wherein the peptide vaccine comprises about 0.250 mg GM-CSF.
10. The method of claim 1 , further comprising administering to the subject a booster composition about six months, or about one year after the primary immunization schedule is completed, wherein the booster composition comprises an effective amount of a peptide consisting of an amino acid sequence selected from the group consisting of SEQ ID NO: 1 and SEQ ID NO: 2, and an adjuvant.
11. The method of claim 10 , wherein the peptide in the booster composition consists of the amino acid sequence of SEQ ID NO: 1.
12. The method of claim 10 , wherein the peptide in the booster composition consists of the amino acid sequence of SEQ ID NO: 2.
13. The method of claim 10 , wherein the booster composition comprises about 0.1 mg to about 2 mg of the peptide.
14. The method of claim 13 , wherein the booster composition comprises about 0.5 mg to about 1.0 mg of the peptide.
15. The method of claim 10 , wherein the adjuvant in the booster composition is GM-CSF.
16. The method of claim 15 , wherein the booster composition comprises about 0.01 mg to about 0.5 mg GM-CSF.
17. The method of claim 16 , wherein the booster composition comprises about 0.250 mg GM-CSF.
18. The method of claim 10 , wherein the booster composition is administered about six months after the completion of the primary immunization schedule.
19. The method of claim 1 , wherein the subject has no evidence of disease (NED).
20. The method of claim 1 , wherein the peptide vaccine is administered within about three months after treatment with one or more cancer therapies selected from the group consisting of surgery, radiation, chemotherapy or a combination of one or more thereof.
21. The method of claim 1 , wherein the human subject, prior to remission, had ovarian cancer cells with low or no expression of FRα, and wherein the method prevents or reduces a risk of ovarian cancer recurrence.
22. The method of claim 1 , wherein the human subject, prior to remission, had endometrial cancer cells with low or no expression of FRα, and wherein the method prevents or reduces a risk of endometrial cancer recurrence.