Claims for Patent: 9,987,357

Summary for Patent: 9,987,357

Title:	Methods and monitoring of treatment with a WNT pathway inhibitor
Abstract:	Methods for treating diseases such as cancer comprising administering a Wnt pathway inhibitor, either alone or in combination with other anti-cancer agents, and monitoring for skeletal-related side effects and/or toxicity.
Inventor(s):	Dupont; Jakob (Hillsborough, CA), Stagg; Robert J. (Moraga, CA)
Assignee:	OncoMed Pharmaceuticals, Inc. (Redwood City, CA)
Application Number:	15/147,521
Patent Claims:	1. A method of treating cancer in a subject in need thereof, comprising: (a) administering to the subject a therapeutically effective amount of a soluble receptor comprising a Fri domain of a human FZD8 protein; and (b) determining the level of a bone resorption biomarker in a sample from the subject. 2. The method of claim 1, wherein the Fri domain of a human FZD8 protein is selected from the group consisting of SEQ II) NO:20, SEQ ID NO: 30, or SEQ ID NO:33. 3. The method of claim 1, wherein the soluble receptor further comprises a non-FZD8 polypeptide, and wherein the Fri domain of a human FZD8 protein is directly linked to the non-FZD8 polypeptide or is linked to the non-FZD8 polypeptide by a linker. 4. The method of claim 3, wherein the non-FZD8 polypeptide comprises a human Fe region. 5. The method of claim 4, wherein the human Fe region consists of SEQ ID NO:34, SEQ ID NO:35, SEQ ID NO:36, SEQ ID NO:37, or SEQ ID NO:38. 6. The method of claim 1, wherein the soluble receptor comprises (a) a first polypeptide consisting essentially of SEQ ID NO:20, SEQ ID NO:30, or SEQ ID NO:33; and (b) a second polypeptide consisting essentially of SEQ II) NO:34, SR) II) NO:35, SEQ ID NO:36, SEQ ID NO:37, or SEQ ID NO:38; wherein the first polypeptide is directly linked to the second polypeptide or the first polypeptide is connected to the second polypeptide by a linker. 7. The method of claim 1, wherein the soluble receptor comprises the amino acid sequence of SEQ ID NO: 45. 8. The method of claim 1, wherein the soluble receptor is 54F28. 9. The method of claim 1, wherein the bone resorption biomarker is selected from the group consisting of: urinary hydroxyproline, urinary total pyridinoline (PYD), urinary free deoxypryidinoline (DPD), urinary collagen type 1 cross-linked N-telopeptide (NTX), urinary or serum collagen type 1 cross-linked C-telopeptide (CTX), bone sialoprotein (BSP), and tartrate-resistant acid phosphatase 5b and .beta.-CTX. 10. The method of claim 9, wherein the bone resorption biomarker is .beta.-CTX. 11. A method for reducing a skeletal-related side effect and/or toxicity in a subject receiving treatment with a soluble receptor comprising a Fri domain of a human FZD8 protein, comprising administering to the subject a therapeutically effective amount of an anti-resorptive medication. 12. The method of claim 11, wherein the soluble receptor comprising a Fri domain of human FZD8 protein comprises (a) a first polypeptide consisting essentially of SEQ ID NO:20, SEQ. ID NO:30, or SEQ ID NO:33; and (b) a second polypeptide consisting essentially of SEQ ID NO:34, SEQ ID NO:35, SEQ ID NO:36, SEQ ID NO:37, or SEQ ID NO:38; wherein the first polypeptide is directly linked to the second polypeptide or the first polypeptide is connected to the second polypeptide by a linker. 13. The method of claim 11, wherein the soluble receptor comprises the amino acid sequence of SEQ ID NO: 45. 14. The method of claim 11, wherein the soluble receptor is 54F28. 15. The method of claim 11, wherein the anti-resorptive medication is a bisphosphonate or denosumab. 16. A method of preventing or attenuating the development of a skeletal-related side effect and/or toxicity in a subject receiving treatment with a soluble receptor comprising a Fri domain of a human FZD8 protein, comprising administering to the subject a therapeutically effective amount of an anti-resorptive medication. 17. The method of claim 16, wherein the soluble receptor comprising a Fri domain of human FZD8 protein comprises (a) a first polypeptide consisting essentially of SEQ ID NO:20, SEQ ID NO:30, or SEQ ID NO:33; and (b) a second polypeptide consisting essentially of SEQ ID NO:34, SEQ ID NO:35, SEQ ID NO:36, SEQ NO:37, or SEQ II) NO:38; wherein the first polypeptide is directly linked to the second polypeptide or the first polypeptide is connected to the second polypeptide by a linker. 18. The method of claim 16, wherein the soluble receptor comprises the amino acid sequence of SEQ ID NO: 45. 19. The method of claim 16, wherein the soluble receptor is 54F28. 20. The method of claim 16, wherein the anti-resorptive medication is a bisphosphonate or denosumab.

Details for Patent 9,987,357

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	PROLIA	denosumab	Injection	125320	06/01/2010		2033-02-04
Amgen, Inc.	XGEVA	denosumab	Injection	125320	11/18/2010		2033-02-04