Claims for Patent: 9,572,878

Summary for Patent: 9,572,878

Title:	Method of combination therapy using an EGFR antagonist and anti-c-Met antibody
Abstract:	A method of combination therapy for prevention and/or treatment of c-Met- and/or EGFR-induced diseases including co-administering a pharmaceutically effective amount of an EGFR antagonist and a pharmaceutically effective amount of an anti-c-Met antibody to a subject in need thereof is provided.
Inventor(s):	Lee; Saet Byoul (Seoul, KR), Choi; Jae Hyun (Seongnam-si, KR), Kim; Kyung Ah (Seongnam-si, KR), Lee; Ji Min (Seoul, KR), Jeong; Yun Ju (Hwaseong-si, KR), Park; Keunchil (Seoul, KR), Kim; Youngwook (Seongnam-si, KR), Lee; Yumi (Seoul, KR)
Assignee:	SAMSUNG ELECTRONICS CO., LTD. (Suwon-si, KR) SAMSUNG LIFE WELFARE FOUNDATION (Seoul, KR)
Application Number:	14/227,759
Patent Claims:	1. A method for the treatment of a c-Met-induced or EGFR-induced cancer, comprising co-administering a pharmaceutically effective amount of (a) a small-molecule EGFR inhibitor and (b) an anti-c-Met antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti c-Met antibody or the antigen-binding fragment thereof comprises a complementarity determining region H1 (CDR-H1) comprising the amino acid sequence of SEQ ID NO: 1, a CDR-H2 comprising the amino acid sequence of SEQ ID NO: 2, a CDR-H3 comprising the amino acid sequence of SEQ ID NO: 3, a CDR-L1 comprising the amino acid sequence of SEQ ID NO: 10, a CDR-L2 comprising the amino acid sequence of SEQ ID NO: 11, and a CDR-L3 comprising the amino acid sequence of SEQ ID NO: 13. 2. The method of claim 1, wherein the small-molecule EGFR inhibitor and the anti-c-Met antibody or antigen-binding fragment thereof are administered simultaneously or sequentially in any order. 3. The method of claim 1, wherein the small-molecule EGFR inhibitor comprises at least one selected from the group consisting of erlotinib and gefitinib. 4. The method of claim 1, wherein the anti-c-Met antibody comprises: a heavy chain comprising the amino acid sequence from the 18.sup.th to 462.sup.nd positions of SEQ ID NO: 62, the amino acid sequence from the 18.sup.th to 461.sup.st positions of SEQ ID NO: 64, or the amino acid sequence from the 18.sup.th to 460.sup.th positions of SEQ ID NO: 66; and a light chain comprising the amino acid sequence from the 21.sup.st to 240.sup.th positions of SEQ ID NO: 68, the amino acid sequence from the 21.sup.st to 240.sup.th positions of SEQ ID NO: 70, or the amino acid sequence of SEQ ID NO: 108. 5. The method of claim 1, wherein the anti-c-Met antibody is a monoclonal antibody. 6. The method of claim 1, wherein the anti-c-Met antibody is a mouse antibody, a mouse-human chimeric antibody, or a humanized antibody. 7. The method of claim 1, wherein the antigen-binding fragment is selected from the group consisting of scFv, (scFv).sub.2, Fab, Fab', and F(ab').sub.2 of the anti-c-Met antibody. 8. The method of claim 1, wherein the anti-c-Met antibody is provided by a bispecific antibody comprising an anti-c-Met antibody or an antigen-binding fragment thereof and a VEGF-binding fragment. 9. The method of claim 8, wherein the VEGF-binding fragment is an anti-VEGF antibody, an antigen-binding fragment of the anti-VEGF antibody, a VEGF receptor, or a VEGF-binding region of the VEGF receptor. 10. The method of claim 8, wherein the VEGF-binding fragment is bevacizumab, an antigen-binding fragment of bevacizumab, human VEGF Receptor 1 (SEQ ID NO: 113), the second Ig-like domain 2 (VIG2) of SEQ ID NO: 114, or a polypeptide comprising 101 to 1338 consecutive amino acids within the amino acid sequence of SEQ ID NO: 113, wherein the 101 to 1338 consecutive amino acids comprises SEQ ID NO: 114. 11. The method according to claim 8, wherein the bispecific antibody further comprises a linker comprising 1 to 100 amino acids between the anti-c-Met antibody or the antigen-binding fragment thereof and the VEGF-binding fragment. 12. The method according to claim 1, wherein the c-Met-induced or EGFR-induced cancer is an EGFR antagonist resistant cancer. 13. A method for overcoming resistance to an EGFR antagonist, comprising administering a pharmaceutically effective amount of a small-molecule EGFR inhibitor together with an anti-c-Met antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti c-Met antibody or the antigen-binding fragment thereof comprises: a CDR-H1 comprising the amino acid sequence of SEQ ID NO: 1, a CDR-H2 comprising the amino acid sequence of SEQ ID NO: 2, a CDR-H3 comprising the amino acid sequence of SEQ ID NO: 3, a CDR-L1 comprising the amino acid sequence of SEQ ID NO: 10, a CDR-L2 comprising the amino acid sequence of SEQ ID NO: 11, and a CDR-L3 comprising the amino acid sequence of SEQ ID NO: 13.

Details for Patent 9,572,878

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2033-03-27