Methods and compositions for screening and detecting biomarkers
AssigneeEDP Biotech Corporation
InventorNancy Tommye Ann Jordan
Life of this patent
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Abstract
The present invention is concerned with a novel antigens associated with human tumors, including carcinomas of the colon or lung, as well as novel monoclonal antibodies which specifically bind to said antigen. The antibodies bind to normal human cells to a much lesser degree than to tumor cells. The antigens include 100 kDa glycoprotein that has a colorectal cancer membrane bound and a soluble form, has a UV absorbance peak at about 228 nm, an isoelectric point of about 3.5 to 4, a sialic acid content of about 20%, and does not substantially bind to an antibody specific for ACT. The antibodies find use both in methods such as the detection of malignant cells associated with tumors and in monitoring therapeutic treatment of humans with tumors.
Claims21
An immunoassay for determining whether a subject is at risk of colorectal cancer comprising:
- a) combining an antibody or antigen binding fragment thereof with a human tissue or fluid sample from the subject;
- wherein the antibody or antigen binding fragment specifically binds to a 100 kDa glycoprotein comprising SEQ ID NO:1, but does not substantially bind to glycosylated 180 kDa CEA and one or more linear peptides consisting of a linear peptide of 15 amino acids from amino acids 1-60 of SEQ ID NO:2, a linear peptide of amino acids 111 to 125 of SEQ ID NO:3, and/or a linear peptide of 15 amino acids from amino acids 150-701 of SEQ ID NO:4;
- and b) determining the amount of the antigen in the human tissue or fluid by determining the amount of the antibody antigen complex.
An immunoassay kit comprising:
- a) a first antibody that specifically binds to a 100 kDa glycoprotein comprising SEQ ID NO:1, but does not bind to glycosylated 180 kDa CEA and one or more linear peptides consisting of a linear peptide of 15 amino acids from amino acids 1-60 of SEQ ID NO:2, a linear peptide of amino acids 111 to 125 of SEQ ID NO:3, and/or a linear peptide of 15 amino acids from amino acids 150-701 of SEQ ID NO:4;
- b) an additional antibody that specifically binds to a 100 kDa glycoprotein comprising SEQ ID NO:1, labeled with a signal generating element, wherein the first antibody has a different epitope specificity than the second antibody;
- and c) a calibrator.
An isolated antibody or antigen-binding fragment thereof that specifically binds to a 100 kDa glycoprotein comprising SEQ ID NO:1, but does not substantially bind to glycosylated 180 kDa CEA and one or more linear peptides consisting of a linear peptide of 15 amino acids from amino acids 1-60 of SEQ ID NO:2, a linear peptide of amino acids 111 to 125 of SEQ ID NO:3, and/or a linear peptide of 15 amino acids from amino acids 150-701 of SEQ ID NO:4.
An isolated antibody or antigen-binding fragment thereof that specifically binds to or competes for binding to an epitope of 100 kDa glycoprotein comprising SEQ ID NO:1, wherein the epitope comprises amino acids 61-69, 73-77, and 96-107 of SEQ ID NO:1.
An isolated antibody or antigen-binding fragment thereof that specifically binds to or competes for binding to an epitope of 100 kDa glycoprotein comprising SEQ ID NO:1, wherein the epitope comprises amino acids 61-69, 78-98, 96-107, and 127-139 of SEQ ID NO:1.
An isolated antibody or antigen-binding fragment thereof that specifically binds to a 100 kDa glycoprotein comprising SEQ ID NO:1, but does not bind to glycosylated 180 kDa CEA, wherein the antibody or antigen binding fragment comprises:
- (a) heavy chain CDRs (HCDR1, HCDR2 and HCDR3) from a heavy chain variable region having an amino acid sequence selected from the group consisting of SEQ ID NO:119 and SEQ ID NO:121;
- and (b) light chain CDRs (LCDR1, LCDR2 and LCDR3) from a light region having an amino acid sequence selected from the group consisting of SEQ ID NO:120 and SEQ ID NO:122.
Dependencies are inferred from the claim text.