Claims for Patent: 7,858,087

Summary for Patent: 7,858,087

Title:	Enhancing the efficacy of immunotherapies by supplementing with complement
Abstract:	The present invention is directed to a composition and method for enhancing the complement-mediated cytotoxicity of therapeutic antibodies for their target cells (i.e. those cells displaying the target epitope). More particularly the present invention enhances the efficacy of such therapies by providing a supplemental source of complement.
Inventor(s):	Taylor; Ronald P. (Charlottesville, VA), Lindorfer; Margaret A. (Charlottesville, VA), Solga; Michael D. (Charlottesville, VA), Kennedy; Adam (Charlottesville, VA)
Assignee:	University of Virginia Patent Foundation (Charlottesville, VA)
Application Number:	11/881,036
Patent Claims:	1. A method of enhancing the cytotoxic activity of chimeric anti-CD20 monoclonal antibody IDEC-C2B8 for its target cells in a patient suffering from a neoplastic disease, said method comprising administering to said patient a composition comprising said chimeric anti-CD20 monoclonal antibody; and administering to said patient a composition comprising compatible human serum or citrated plasma comprising complement component 2. 2. The method claim 1 wherein the monoclonal antibody IDEC-C2B8 and the human complement factor are combined and administered as a single composition. 3. The method of claim 1 wherein the human serum or plasma is prepared from AB type blood. 4. A method of enhancing the cytotoxic activity of chimeric anti-CD20 monoclonal antibody IDEC-C2B8 (RITUXIMAB) for its target cells in a patient suffering from a neoplastic disease, said method comprising measuring the complement levels in a blood sample obtained from said patient; and administering said monoclonal antibody IDEC-C2B8 in conjunction with administering a composition comprising compatible human serum or citrated plasma comprising complement component 2 to said patient when the complement levels of said patient are insufficient to support adequate complement activation. 5. The method of claim 4 wherein the patient having insufficient levels of complement is identified by contacting a serum or plasma sample obtained from said patient with the monoclonal antibody IDEC-C2B8 to form a reaction mixture; incubating the reaction mixture in the presence absence of human serum or plasma complement proteins; and determining whether the sample exhibits higher opsonization or cell killing in the presence of human serum or plasma complement as the criteria for identifying a patient having insufficient levels of complement and that would be administered both the monoclonal antibody IDEC-C2B8 and said human serum or plasma. 6. The method of claim 4 wherein the monoclonal antibody IDEC-C2B8 and the human serum or plasma are administered as a single composition. 7. The method of claim 4 wherein said human serum or plasma is administered in conjunction with the monoclonal antibody IDEC-C2B8 when the measured CH50 level of said patient's blood sample is 150 or lower.

Details for Patent 7,858,087

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2021-08-10
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2021-08-10
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2021-08-10