Claims for Patent: 8,088,737

Summary for Patent: 8,088,737

Title:	Compositions, methods and kits relating to Her-2 cleavage
Abstract:	The present invention relates to compositions, methods and kits based on the ADAM-mediated cleavage of Her-2. The present invention also relates to treatments for cancer, and in particular, breast cancer, by modulating the ADAM-mediated cleavage of Her-2. Further, the invention relates to compositions, methods and kits based on the surprising synergistic effect between inhibition of Her-2 cleavage by an ADAM and certain cytostatic (e.g., Herceptin) and cytotoxic (e.g., Taxol) compounds in, among other things, inhibiting tumor cell proliferation and inducing cell death. Additionally, the invention relates to novel variants of ADAM15, designated ADAM15 variant 1 and ADAM15 variant 2, now identified and isolated.
Inventor(s):	Friedman; Steven M. (West Chester, PA), Scherle; Peggy A. (Media, PA), Liu; Xiangdong (Metchuen, NJ), Burn; Timothy C. (Hockessin, DE), Huber; Reid (Wilmington, DE), Liu; Phillip C. C. (Wilmington, DE), Hollis; Gregory F. (Wilmington, DE), Vaddi; Krishna (Hockessin, DE), Fridman; Jordan S. (Newark, DE)
Assignee:	Incyte Corporation (Wilmington, DE)
Application Number:	10/817,718
Patent Claims:	1. A method of treating cancer in a patient, wherein said cancer overexpresses Her-2, comprising administering to said patient a therapeutically effective amount of an ADAM inhibitor which is methyl (6S,7S)-7-[(hydroxyamino)carbonyl]-6-[(4-phenylpiperazin-1-yl)carbonyl]-5- -azaspiro[2.5]octane-5-carboxylate, and further comprising administering to said patient a therapeutically effective amount of an anti-Her-2 antibody. 2. A method according to claim 1, wherein said cancer is breast cancer. 3. A method according to claim 1, wherein said anti-Her-2 antibody is trastuzumab. 4. A method according to claim 2, wherein said anti-Her-2 antibody is trastuzumab. 5. A method of inhibiting metastasis of cancer in a patient, wherein said cancer overexpresses Her-2, comprising administering to said patient a therapeutically effective amount of an ADAM inhibitor which is methyl (6S,7S)-7-[(hydroxyamino)carbonyl]-6-[(4-phenylpiperazin-1-yl)carbonyl]-5- -azaspiro[2.5]octane-5-carboxylate, and further comprising administering to said patient a therapeutically effective amount of an anti-Her-2 antibody. 6. A method according to claim 5, wherein said cancer is breast cancer. 7. A method according to claim 5, wherein said anti-Her-2 antibody is trastuzumab. 8. A method according to claim 6, wherein said anti-Her-2 antibody is trastuzumab. 9. A method of inhibiting growth of a tumor in a patient, wherein the tumor overexpresses Her-2, comprising administering to said patient a therapeutically effective amount of an ADAM inhibitor which methyl (6S,7S)-7-[(hydroxyamino)carbonyl]-6-[(4-phenylpiperazin-1-yl)carbonyl]-5- -azaspiro[2.5]octane-5-carboxylate and further comprising administering to said patient a therapeutically effective amount of an anti-Her-2 antibody. 10. A method according to claim 9, wherein said tumor is a breast cancer tumor. 11. A method according to claim 10, wherein said anti-Her-2 antibody is trastuzumab. 12. A method according to claim 11, wherein said anti-Her-2 antibody is trastuzumab.

Details for Patent 8,088,737

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2023-04-04
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2023-04-04
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2023-04-04