Claims for Patent: 8,980,268

Summary for Patent: 8,980,268

Title:	Methods for treating cancer by administering an anti-Ang-2 antibody
Abstract:	The present invention provides antibodies that bind to angiopoietin-2 (Ang-2) and methods of using same. According to certain embodiments of the invention, the antibodies are fully human antibodies that bind to human Ang-2. The antibodies of the invention are useful, inter alia, for the treatment of diseases and disorders associated with one or more Ang-2 biological activities including angiogenesis.
Inventor(s):	Lowy; Israel (Dobbs Ferry, NY), Thurston; Gavin (White Plains, NY), Daly; Christopher (New York, NY)
Assignee:	Regeneron Pharamceuticals, Inc. (Tarrytown, NY)
Application Number:	13/747,728
Patent Claims:	1. A method for treating a tumor, the method comprising administering to a patient in need of such treatment a pharmaceutical composition comprising a therapeutically effective amount of an isolated antibody or antigen-binding fragment thereof that specifically binds human angiopoietin-2 (hAng-2) but does not substantially bind hAng-1, wherein the antibody or antigen binding fragment comprises the complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) having the amino acid sequence of SEQ ID NO: 18 and the CDRs of a light chain variable region (LCVR) having the amino acid sequence of SEQ ID NO: 20. 2. The method of claim 1, wherein the antibody or antigen binding fragment comprises a heavy chain CDR1 (HCDR1) having the amino acid sequence of SEQ ID NO: 4, an HCDR2 having the amino acid sequence of SEQ ID NO: 6, an HCDR3 having the amino acid sequence of SEQ ID NO: 8, a light chain CDR1 (LCDR1) having the amino acid sequence of SEQ ID NO: 12, a LCDR2 having the amino acid sequence of SEQ ID NO: 14, and an LCDR3 having the amino acid sequence of SEQ ID NO: 16. 3. The method of claim 1, wherein the antibody or antigen binding fragment binds an epitope on hAng-2 (SEQ ID NO: 518) comprising an amino acid selected from the group consisting of F-469, Y-475 and S-480. 4. The method of claim 1, wherein the antibody or antigen binding fragment binds an epitope on hAng-2 comprising amino acids F-469, Y-475 and S-480. 5. The method of claim 1, wherein the tumor is present in ovary, colon, or liver of the patient. 6. The method of claim 1 further comprising administering a second therapeutic agent. 7. The method of claim 6, wherein the second therapeutic agent is selected from the group consisting of an anti-VEGF (vascular endothelial growth factor) antibody, a small molecule kinase inhibitor of VEGF receptor and a VEGF-inhibiting fusion protein. 8. The method of claim 7, wherein the second therapeutic agent is aflibercept or bevacizumab. 9. A method of treating an advanced solid tumor malignancy, the method comprising administering to a patient in need of such treatment a pharmaceutical composition comprising a therapeutically effective amount of an isolated antibody or antigen-binding fragment thereof that specifically binds human angiopoietin-2 (hAng-2) but does not substantially bind hAng-1, wherein the antibody or antigen binding fragment comprises the complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) having the amino acid sequence of SEQ ID NO: 18 and the CDRs of a light chain variable region (LCVR) having the amino acid sequence of SEQ ID NO: 20. 10. The method of claim 9, wherein the antibody or antigen binding fragment comprises a heavy chain CDR1 (HCDR1) having the amino acid sequence of SEQ ID NO: 4, an HCDR2 having the amino acid sequence of SEQ ID NO: 6, an HCDR3 having the amino acid sequence of SEQ ID NO: 8, a light chain CDR1 (LCDR1) having the amino acid sequence of SEQ ID NO: 12, a LCDR2 having the amino acid sequence of SEQ ID NO: 14, and an LCDR3 having the amino acid sequence of SEQ ID NO: 16. 11. The method of claim 9, wherein the antibody or antigen binding fragment binds an epitope on hAng-2 (SEQ ID NO: 518) comprising an amino acid selected from the group consisting of F-469, Y-475 and S-480. 12. The method of claim 9 further comprising administering a second therapeutic agent. 13. The method of claim 12, wherein the second therapeutic agent is an anti-angiogenic agent. 14. The method of claim 13, wherein the anti-angiogenic agent is selected from the group consisting of an anti-VEGF (vascular endothelial growth factor) antibody, a small molecule kinase inhibitor of VEGF receptor and a VEGF-inhibiting fusion protein. 15. The method of claim 14, wherein the anti-angiogenic agent is aflibercept or bevacizumab. 16. The method of claim 15, wherein the advanced solid tumor malignancy is present in the ovary, colon or liver of the patient. 17. The method of claim 16, wherein the advanced solid tumor malignancy is resistant to conventional therapy. 18. The method of claim 17, wherein the advanced solid tumor malignancy is advanced platinum-resistant ovarian cancer. 19. A method of inhibiting angiogenesis in an advanced solid tumor, the method comprising administering to a patient in need of such treatment a pharmaceutical composition comprising a therapeutically effective amount of an isolated antibody or antigen-binding fragment thereof that specifically binds human angiopoietin-2 (hAng-2) but does not substantially bind hAng-1, wherein the antibody or antigen binding fragment comprises the complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) having the amino acid sequence of SEQ ID NO: 18 and the CDRs of a light chain variable region (LCVR) having the amino acid sequence of SEQ ID NO: 20. 20. The method of claim 19, wherein the antibody or antigen binding fragment comprises a heavy chain CDR1 (HCDR1) having the amino acid sequence of SEQ ID NO: 4, an HCDR2 having the amino acid sequence of SEQ ID NO: 6, an HCDR3 having the amino acid sequence of SEQ ID NO: 8, a light chain CDR1 (LCDR1) having the amino acid sequence of SEQ ID NO: 12, a LCDR2 having the amino acid sequence of SEQ ID NO: 14, and an LCDR3 having the amino acid sequence of SEQ ID NO: 16. 21. The method of claim 19, wherein the antibody or antigen binding fragment binds an epitope on hAng-2 (SEQ ID NO: 518) comprising an amino acid selected from the group consisting of F-469, Y-475 and S-480. 22. The method of claim 19 further comprising administering a second anti-angiogenic agent. 23. The method of claim 22, wherein the second anti-angiogenic agent is selected from the group consisting of an anti-VEGF (vascular endothelial growth factor) antibody, a small molecule kinase inhibitor of VEGF receptor and a VEGF-inhibiting fusion protein. 24. The method of claim 23, wherein the second anti-angiogenic agent is aflibercept or bevacizumab. 25. The method of 24, wherein the advanced solid tumor is present in ovary, colon or liver of the patient. 26. The method of claim 25, wherein the tumor is advanced platinum-resistant ovarian cancer.

Details for Patent 8,980,268

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2029-07-29
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	11/18/2011		2029-07-29
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	08/16/2018		2029-07-29