Claims for Patent: 8,450,068

Summary for Patent: 8,450,068

Title:	IgE antibodies to chimeric or humanized IgG therapeutic monoclonal antibodies as a screening test for anaphylaxis
Abstract:	The present invention provides an assay for detecting serum IgE antibody levels to cetuximab and to other proteins. The present invention further provides a method for predicting whether a subject will respond adversely to cetuximab treatment. The present further provides a method for detecting sensitivity to compounds comprising galactose-alpha-1,3-galactose.
Inventor(s):	Platts-Mills; Thomas A. E. (Charlottesville, VA), Merritt; Tina Hatley (Bentonville, AR)
Assignee:	University of Virginia Patent Foundation (Charlottesville, VA)
Application Number:	12/527,255
Patent Claims:	1. A method of identifying whether a compound comprises the oligosaccharide moiety galactose-alpha-1,3-galactose, said method comprising: combining the compound with an IgE antibody which binds specifically to galactose-alpha-1,3-galactose to form a complex comprising the galactose-alpha-1,3-galactose of the compound bound specifically IgE antibody; and detecting the presence of the complex, wherein the presence of the complex indicates that the compound comprises the oligosaccharide moiety galactose-alpha-1,3-galactose. 2. A method of screening a sample, for the presence or amount of IgE antibodies specific for alphaGal, comprising; (a) contacting the sample with a known amount of an isolated compound comprising the moiety galactose-alpha-1,3-galatose (alphaGal) that specifically binds to said IgE antibodies in the sample, so as to form complexes between alphaGal moieties on said compound and said IgE antibodies; and (b) detecting the presence or amount of said complexes, wherein the presence or amount indicates that the sample comprises said IgE antibodies. 3. The method of claim 2 wherein the presence or amount of IgE is detected by reacting the complex with a secondary enzyme-labeled anti-IgE antibody. 4. The method of claim 2, wherein the sample is screened for the presence of IgE antibodies specific for alphaGal. 5. The method of claim 2, wherein the sample is screened for the amount of IgE antibodies specific for alphaGal. 6. The method of claim 2, wherein said biological sample is selected from the group consisting of blood, serum, and plasma. 7. The method of claim 2, wherein said sample is a human sample. 8. The method of claim 1 or 2, wherein said compound is a protein. 9. The method of claim 8, wherein said protein is an antibody. 10. The method of claim 9, wherein said antibody is a therapeutic antibody. 11. The method of claim 2, wherein said IgE antibody cross-reacts with alphaGal moieties on cetuximab or on the F(ab').sub.2 fragment cetuximab. 12. The method of claim 11, wherein said IgE antibody which forms complexes with alphaGal moieties is measured using an ImmunoCAP assay. 13. The method of claim 12, wherein said ImmunoCAP assay is a modified ImmunoCAP) assay using streptavidin bound to the solid phase. 14. The method of claim 13, wherein the level of said IgE is expressed in IU/ml.

Details for Patent 8,450,068

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2027-02-16
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2027-02-16