Claims for Patent: 9,737,596

Summary for Patent: 9,737,596

Title:	Vaccine for the prevention of breast cancer recurrence
Abstract:	Provided are methods to induce and maintain a protective cytotoxic T-lymphocyte response to a peptide of the HER2/neu oncogene, GP2, with the effect of inducing and maintaining protective or therapeutic immunity against breast cancer in a patient in clinical remission, including patients having low to intermediate levels of HER2/neu expression. The methods comprise administering to the patient an effective amount of a vaccine composition comprising a pharmaceutically acceptable carrier, an adjuvant such as GM-CSF, and the GP2 peptide. The methods may further comprise administering a periodic booster vaccine dose as needed due to declining GP2-specific T cell immunity. Also provided are vaccine compositions for use in the methods.
Inventor(s):	Peoples; George (San Antonio, TX), Ponniah; Sathibalan (Columbia, MD)
Assignee:	The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (Bethesda, MD)
Application Number:	14/813,927
Patent Claims:	1. A method of preventing breast cancer recurrence in a subject comprising: administering to the subject a composition in an amount effective to prevent breast cancer recurrence, wherein the composition comprises a pharmaceutically effective carrier, a peptide consisting of the amino acid sequence SEQ ID NO:2 (GP2) and granulocyte macrophage-colony stimulating factor, wherein, other than the peptide consisting of the amino acid sequence of SEQ ID NO:2 (GP2), the composition does not contain any other Her2/neu-derived peptides; wherein prior to the administering step, the subject is in remission following treatment with a standard course of therapy, and wherein the subject is selected to be administered the composition because cancer cells from the subject prior to remission had a high expression of HER2, and wherein the high expression of HER2 is an immunohistochemistry (IHC) rating of 3.sup.+ or a fluorescence in situ hybridization (FISH) rating of about 2.0 or greater for HER2/neu gene expression. 2. The method of claim 1, wherein the composition is administered by injection or inoculation. 3. The method of claim 2, wherein the injection is an intradermal injection. 4. The method of claim 2, wherein the composition is injected in one or more split doses. 5. The method of claim 4, wherein the injection sites on the subject are located about 5 cm apart from each other. 6. The method of claim 1, wherein the composition is administered every month for six months. 7. The method of claim 1, further comprising administering to the subject a booster comprising an effective amount of a vaccine booster composition comprising a pharmaceutically effective carrier and a peptide consisting of the amino acid sequence of SEQ ID NO:2. 8. The method of claim 7, wherein the booster is administered every six or 12 months after a primary immunization schedule is completed. 9. The method of claim 1, wherein the subject is a human. 10. The method of claim 9, wherein the human expresses human leukocyte antigen A2. 11. The method of claim 1, wherein the granulocyte macrophage-colony stimulating factor is recombinant human granulocyte macrophage-colony stimulating factor. 12. The method of claim 8, wherein the vaccine booster composition further comprises an adjuvant. 13. The method of claim 12, wherein the adjuvant is granulocyte macrophage-colony stimulating factor. 14. The method of claim 1, wherein administering the composition induces a cytotoxic T-lymphocyte response to the peptide consisting of the amino acid sequence SEQ ID NO:2. 15. The method of claim 1, wherein the subject does not have pre-existing immunity to the peptide consisting of the amino acid sequence of SEQ ID NO:2. 16. The method of claim 1, wherein the standard course of therapy comprises treatment with trastuzumab. 17. The composition of claim 1, wherein the composition is administered to the subject concurrently with trastuzumab.

Details for Patent 9,737,596

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2039-02-26
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2039-02-26
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2039-02-26