Claims for Patent: 10,208,130

Summary for Patent: 10,208,130

Title:	Quantifying Her2 protein for optimal cancer therapy
Abstract:	Improved methods of treatment are provided for patients suffering from cancer. The methods identify whether a tumor will be responsive to treatment with a therapeutic regime that includes anti-Her2 therapeutic agents. A specific Her2 fragment peptide is precisely quantitated by SRM-mass spectrometry directly in tumor cells collected from tumor tissue that was obtained from a cancer patient and compared to a reference level in order to determine if the cancer patient will positively respond to treatment with a therapeutic agent that specifically targets the Her2 protein.
Inventor(s):	Bang; Yung-Jue (Seoul, KR), Hembrough; Todd (Gaithersburg, MD), An; Eunkyung (Bethesda, MD), Oh; Do-Youn (Seoul, KR)
Assignee:	Expression Pathology, Inc. (Rockville, MD) Department of Internal Medicine and Cancer Research, Seoul National University Hospital (Seoul, KR)
Application Number:	15/169,724
Patent Claims:	1. A method of treating a patient suffering from gastric cancer comprising: (a) quantifying the level of a specified Her2 fragment peptide in a protein digest prepared from a tumor sample obtained from the patient and calculating the level of the Her2 peptide in said sample by selected reaction monitoring using mass spectrometry; (b) comparing the level of said Her2 fragment peptide to a reference level, wherein said reference level is about 1825 amol/.mu.g+/-250 amol/.mu.g, and (c) treating the patient with a therapeutic regimen comprising standard chemotherapy and an effective amount of an anti-Her2 therapeutic agent when the level of the Her2 fragment peptide is higher than said reference level or (d) treating the patient with a therapeutic standard chemotherapy regimen that does not comprise an effective amount of an anti-Her2 therapeutic agent when the level of the Her2 fragment peptide is below said reference level. 2. The method of claim 1 wherein said reference level is 1825 amol/.mu.g, +/-150 amol/.mu.g of biological sample protein analyzed. 3. The method of claim 1 wherein said reference level is 1825 amol/.mu.g, +/-100 amol/.mu.g of biological sample protein analyzed. 4. The method of claim 1 wherein said reference level is 1825 amol/.mu.g, +/-50 amol/.mu.g of biological sample protein analyzed. 5. The method of claim 1 wherein said reference level is 1825 amol/.mu.g, +/-25 amol/.mu.g of biological sample protein analyzed. 6. The method of claim 1, wherein said protein digest comprises a protease digest. 7. The method of claim 6, wherein said protease digest comprises a trypsin digest. 8. The method of claim 7, wherein the mode of mass spectrometry used is Selected Reaction Monitoring (SRM), Multiple Reaction Monitoring (MRM), and/or multiple Selected Reaction Monitoring (mSRM). 9. The method of claim 1, wherein the specified Her2 peptide has the amino acid sequence as set forth as SEQ ID NO:1. 10. The method of claim 1, wherein the tumor sample is a cell, collection of cells, or a solid tissue. 11. The method of claim 10, wherein the tumor sample is formalin fixed solid tissue. 12. The method of claim 11, wherein the tissue is paraffin embedded tissue. 13. The method of claim 1, wherein quantifying the specified Her2 fragment peptide comprises determining the amount of the Her2 peptide in said sample by comparing to a spiked internal standard peptide of known amount, wherein both the native peptide in the biological sample and the internal standard peptide corresponds to the same amino acid sequence of the Her2 fragment peptide as shown in SEQ ID NO:1. 14. The method of claim 4, wherein the internal standard peptide is an isotopically labeled peptide, wherein the isotopically labeled internal standard peptide comprises one or more heavy stable isotopes selected from .sup.18O, .sup.17O, .sup.15N, .sup.13C, .sup.2H or combinations thereof. 15. The method of claim 1, wherein detecting and quantitating the specified Her2 fragment peptide can be combined with detecting and quantitating other peptides from other proteins in multiplex so that the treatment decision about which agent used for treatment is based upon specific levels of the specified Her2 fragment peptide in combination with other peptides/proteins in the biological sample. 16. The method of claim 1 wherein when said level of said specified peptide is higher than said reference level, then said anti-Her2 therapeutic agent comprises trastuzumab.

Details for Patent 10,208,130

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2035-05-29
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2035-05-29
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2035-05-29