Claims for Patent: 7,662,926

Summary for Patent: 7,662,926

Title:	Anti-Fc-gamma receptor antibodies, bispecific variants and uses therefor
Abstract:	The present application describes antibodies that selectively bind human Fc.gamma.RIIB, with little or no binding to other human Fc.gamma.Rs, e.g., human Fc.gamma.RIIA. The invention also provides isolated bispecific antibodies comprising an antibody that selectively binds Fc.gamma.RIIB, and a second antibody that specifically binds an activating receptor. Various uses, including therapeutic uses, for those antibodies are also described, including administration with anti-tumor antibodies and methods of inhibiting immune responses and suppressing histamine release.
Inventor(s):	Chan; Andrew C. (Menlo Park, CA), Shields; Robert L. (San Mateo, CA), Wu; Lawren (Foster City, CA)
Assignee:	Genentech, Inc. (South San Francisco, unknown)
Application Number:	11/624,523
Patent Claims:	1. An isolated antibody or an antigen binding fragment thereof, comprising a heavy chain CDR1 having the sequence of SEQ ID NO: 1, a heavy chain CDR2 having the sequence of SEQ ID NO:2, a heavy chain CDR3 having the sequence of SEQ ID NO:3, a light chain CDR1 having the sequence of SEQ ID NO:4, a light chain CDR2 having the sequence of SEQ ID NO:5, and a light chain CDR3 having the sequence of SEQ ID NO:6, wherein the antibody selectively binds Fc.gamma.RIIB receptor. 2. An isolated antibody comprising a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO: 7, wherein said antibody selectively binds Fc.gamma.RIIB. 3. An isolated antibody comprising a light chain variable domain comprising the amino acid sequence of SEQ ID NO: 8, wherein said antibody selectively binds Fc.gamma.RIIB. 4. The isolated antibody or an antigen binding fragment thereof of claim 1, comprising a heavy chain variable domain comprising the amino acid sequences SEQ ID NO:7 and a light chain variable domain comprising the amino acid sequence of SEQ ID NO:8. 5. The antibody or an antigen binding fragment thereof of claim 1, wherein the antibody is a monoclonal antibody, a chimeric antibody, or a humanized antibody. 6. The antibody or an antigen binding fragment thereof of claim 1, wherein the antibody antagonizes the binding of an antibody Fc region to Fc.gamma.RIIB. 7. The antibody or an antigen binding fragment thereof of claim 1, having the binding characteristics of an antibody produced from a hybridoma cell line having ATCC accession number PTA-4614. 8. An isolated antibody, or antigen binding fragment thereof, produced from a hybridoma cell line having ATCC accession number PTA-4614. 9. An isolated bispecific antibody comprising: a) a first arm with binding specificity for Fc.gamma.RIIB comprises the antibody or antigen binding fragment thereof of claim 1; and b) a second arm comprising an antibody or antigen binding fragment that specifically binds Fc.epsilon.RI.alpha.. 10. The isolated bispecific antibody of claim 9, which downregulates Fc.epsilon.RI.alpha. expression, but does not downregulate Fc.gamma.RIA on a cell. 11. The isolated bispecific antibody of claim 9, wherein the antibody or antigen binding fragment thereof of the second arm is a monoclonal antibody, a chimeric antibody, or humanized antibody. 12. The isolated bispecific antibody of claim 10, wherein the cell is a B-cell or mast cell. 13. The isolated bispecific antibody of claim 12, wherein the cell is a human cell. 14. The isolated bispecific antibody of claim 9, wherein the second arm binds to Fc.epsilon.RI.alpha. when Fc.epsilon.RI.alpha. is bound to IgE. 15. The isolated bispecific antibody of claim 9, wherein the first arm of the bispecific antibody blocks binding to Fc.gamma.RIIB by the anti-Fc.gamma.RIIB antibody secreted by the hybridoma having ATCC accession number PTA-4614. 16. An isolated bispecific antibody comprising: a) a first arm with binding specificity for Fc.gamma.RIIB comprises an antibody produced from a hybridoma cell line having ATCC accession number PTA-4614 or an antigen binding fragment thereof, that selectively binds Fc.gamma.RIIB; and b) a second arm comprising an antibody or antigen binding fragment thereof that specifically binds an activating receptor. 17. The isolated bispecific antibody of claim 16, wherein the antibody of the second arm is a monoclonal antibody, a chimeric antibody, a humanized antibody. 18. The isolated bispecific antibody of claim 16, wherein the first arm, comprises a heavy chain CDR1, a heavy chain CDR2, a heavy chain CDR3, a light chain CDR1, a light chain CDR2 and a light chain CDR3 of the antibody produced from a hybridoma cell line having ATCC accession number PTA-4614. 19. The isolated bispecific antibody of claim 16, wherein the antibody or antigen binding fragment of the first arm comprises all six heavy and light chain CDRs of the antibody produced from hybridoma cell line ATCC accession number PTA-4614. 20. The isolated bispecific antibody of claim 16, wherein the antigen binding fragments of the first or second arm is an antibody fragment selected from the group consisting of Fab, Fab', Fab.sub.2, Fab'.sub.2, Fd, Fd', scFv, scFv.sub.2, dAb. 21. The bispecific antibody of claim 16, wherein the first antibody is covalently bound to the second antibody. 22. The bispecific antibody of claim 16, wherein the first and second antigen binding polypeptides or antibodies are covalently bound via a linker comprising at least five amino acids. 23. The bispecific antibody of claim 16, wherein the bispecific antibody comprises a variant heavy chain hinge region incapable of inter-heavy chain disulfide linkage. 24. The bispecific antibody of claim 16, wherein the first antigen binding polypeptide or antibody, binds human Fc.gamma.RIIB and demonstrates little or no binding to human Fc.gamma.RIIA. 25. A composition comprising the antibody or antigen binding fragment thereof of any of claims 1, 2-7, 8, 9-13, 14-15, 16-20, and 21-24 and a pharmaceutical carrier. 26. The composition of claim 25 further comprising an anti-IgE antibody. 27. The composition of claim 26, wherein the anti-IgE antibody is omalizumab. 28. A kit comprising the composition of claim 25, further comprising a container and a label. 29. A kit comprising the composition of claim 26, wherein the anti-IgE antibody is omalizumab. 30. A kit comprising the composition of claim 26, further comprising a container and label. 31. The kit of claim 29, wherein the ratio of bispecific antibody to anti-IgE antibody is 0.01:1 to 100:1. 32. The kit of claim 31, wherein the ratio is 0.05:1. 33. The kit of claim 32, wherein the ratio is 0.1:1. 34. The kit of claim 33, wherein the ratio is 0.5:1. 35. The kit of claim 34, wherein the ratio is 1:1. 36. The kit of claim 29, wherein the ratio is 1:0.5. 37. The kit of claim 29, wherein the ratio is 1:0.1. 38. The kit of claim 29, wherein the ratio is 1:0.05. 39. The isolated bispecific antibody of claim 16, wherein the antibody of the first arm is chimeric or humanized.

Details for Patent 7,662,926

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	06/20/2003		2039-03-29
Genentech, Inc.	XOLAIR	omalizumab	Injection	103976	09/28/2018		2039-03-29