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Generated: September 19, 2017

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Title:Anti-notch NRR antibodies and methods using same
Abstract: The invention provides anti-Notch1 NRR antibodies, and compositions comprising and methods of using these antibodies.
Inventor(s): Siebel; Christian W. (Berkeley, CA), Wu; Yan (Foster City, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:14/177,452
Patent Claims:1. A method for treating cancer in an individual, the method comprising administering an effective amount of a monoclonal anti-Notch1 negative regulatory region (NRR) antibody to the individual, wherein the antibody binds Notch1 NRR comprising amino acids 1447-1733 of SEQ ID NO:56, and wherein the cancer is not a T-cell leukemia.

2. The method of claim 1, wherein said cancer is a breast cancer.

3. The method of claim 1, wherein said cancer is a colon cancer.

4. The method of claim 1 further comprising administering to the individual an effective amount of a second medicament, wherein the anti-Notch1 NRR antibody is a first medicament.

5. The method of claim 4, wherein the second medicament is another antibody, a chemotherapeutic agent, a cytotoxic agent, an anti-angiogenic agent, an immunosuppressive agent, a prodrug, a cytokine, a cytokine antagonist, cytotoxic radiotherapy, a corticosteroid, an anti-emetic, a cancer vaccine, an analgesic, or a growth-inhibitory agent.

6. The method of claim 4, wherein the second medicament is tamoxifen, letrozole, exemestane, anastrozole, irinotecan, cetuximab, fulvestrant, vinorelbine, erlotinib, bevacizumab, vincristine, imatinib, sorafenib, lapatinib, or trastuzumab.

7. The method of claim 4, wherein the second medicament is administered prior to or subsequent to the administration of the anti-Notch1 NRR antibody.

8. The method of claim 4, wherein the second medicament is administered concurrently with the anti-Notch1 NRR antibody.

9. The method of claim 1, wherein Notch1 expression or a Notch1 ligand expression is determined in a biological sample of the individual before, during or after administration of the anti-Notch1 NRR antibody.

10. The method of claim 1, wherein said individual is a human.

11. The method of claim 1, wherein said anti-Notch1 NRR antibody binds human Notch1 NRR with a Kd of 1.times.10.sup.-7 or stronger.

12. The method of claim 11, wherein the Kd is determined by a surface plasmon resonance assay.

13. The method of claim 11, wherein the Kd is determined by a radiolabeled antigen binding assay.

14. The method of claim 1, wherein the antibody comprises HVR-L1, HVR-L2, HVR-L3, HVR-H1, HVR-H2, and HVR-H3, wherein each, in order, comprises SEQ ID NO:7, 8, 9, 1, 2, 6.

15. The method of claim 1, wherein the antibody comprises HVR-L1, HVR-L2, HVR-L3, HVR-H1, HVR-H2, and HVR-H3, wherein each, in order, comprises SEQ ID NO:7, 8, 10, 1, 3, 6.

16. The method of claim 1, wherein the antibody comprises HVR-L1, HVR-L2, HVR-L3, HVR-H1, HVR-H2, and HVR-H3, wherein each, in order, comprises SEQ ID NO:7, 8, 11, 1, 4, 6.

17. The method of claim 1, wherein the antibody comprises HVR-L1, HVR-L2, HVR-L3, HVR-H1, HVR-H2, and HVR-H3, wherein each, in order, comprises SEQ ID NO:7, 8, 12, 1, 5, 6.

18. The method of claim 1, wherein the antibody induces cancer cell differentiation.

19. The method of claim 1, wherein the antibody reduces tumor angiogenesis.

20. The method of claim 1, wherein the cancer is associated with an activating mutation in Notch 1.

21. The method of claim 1, wherein the antibody comprises a heavy chain variable region sequence of SEQ ID NO:58, 60, 62 or 64, and a light chain variable region sequence of SEQ ID NO:59, 61, 63 or 65.

22. The method of claim 1, wherein the antibody decreases Notch 1 signaling.

23. The method of claim 22, wherein decreased Notch1 signaling is measured using a luciferase reporter assay.

24. The method of claim 23, wherein the antibody decreases Notch1 signaling by at least three fold below levels observed in the absence of the antibody.

25. The method of claim 22, wherein the antibody reduces signaling to about 18% of signaling in the absence of the antibody.

26. The method of claim 22, wherein the Notch1 signaling is ligand-mediated Notch1 signaling.

27. The method of claim 26, wherein the ligand is Jagged1.

28. The method of claim 1, wherein the antibody is a humanized or chimeric antibody.

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Inventors Patent Expiration Status Orphan Source
Genentech
HERCEPTIN
trastuzumab
VIAL; INTRAVENOUS1037920011998-09-25► Subscribe Genentech, Inc. (South San Francisco, CA) Siebel; Christian W. (Berkeley, CA), Wu; Yan (Foster City, CA) ► SubscribeRXOrphansearch
Imclone
ERBITUX
cetuximab
VIAL; INTRAVENOUS1250840012004-06-18► Subscribe Genentech, Inc. (South San Francisco, CA) Siebel; Christian W. (Berkeley, CA), Wu; Yan (Foster City, CA) ► SubscribeRXOrphansearch
Genentech
AVASTIN
bevacizumab
VIAL; INTRAVENOUS1250850012004-02-26► Subscribe Genentech, Inc. (South San Francisco, CA) Siebel; Christian W. (Berkeley, CA), Wu; Yan (Foster City, CA) ► SubscribeRXsearch
Genentech
AVASTIN
bevacizumab
VIAL; INTRAVENOUS1250850022004-02-26► Subscribe Genentech, Inc. (South San Francisco, CA) Siebel; Christian W. (Berkeley, CA), Wu; Yan (Foster City, CA) ► SubscribeRXsearch
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International Patent Family for Patent: ► Subscribe

Country Document Number Publication Date
Argentina066846Sep 16, 2009
Australia2008260439Dec 11, 2008
Australia2008260439Jan 07, 2010
BrazilPI0811382Dec 09, 2014
Canada2687866Dec 11, 2008
China101796074Aug 04, 2010
China101796074May 28, 2014
Colombia6150200Apr 20, 2010
Costa Rica11139Dec 30, 2009
Costa Rica20150088Apr 10, 2015
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