# US 9,753,036 B2 · Methods and compositions for screening and detecting biomarkers > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,753,036 B2 - Document ID: US9753036B2 - Status: Granted - Kind: B2 - Application number: 14/264,801 - Filed: 2014-04-29 - Published: 2015-10-29 - Granted: 2017-09-05 - Earliest claimed: 2014-04-29 - Assignees: EDP Biotech Corporation - Applicants: EDP Biotech Corporation - Inventors: Nancy Tommye Ann Jordan - Web page: https://patentgrep.com/patent/US9753036B2 ## CPC - G01N 33/57535: of the large intestine, e.g. colon, rectum or anus - C07K 16/3046: {Stomach, Intestines} - C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity - C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues - G01N 2800/50: Determining the risk of developing a disease - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## 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. ## Claims ### Claim 1 An immunoassay for determining whether a subject is at risk of cancer, the immunoassay comprising: a) combining an antibody or antigen binding fragment thereof with a sample from the subject; wherein the antibody or antigen binding fragment thereof specifically binds to a 100 kDa glycoprotein comprising SEQ ID NO:1, but does not substantially bind to glycosylated 180 kDa CEA and to one or more linear peptides selected from the group consisting of 15 amino acids from amino acids of SEQ ID NO:2, amino acids of SEQ ID NO:3, and 15 amino acids from amino acids of SEQ ID NO:4, and wherein said antibody or antigen binding fragment binds to an epitope comprised within amino acids of SEQ ID NO:6, 7, 8, 9, 10 or 11; and b) determining the amount of the antigen in the sample by determining the amount of the antibody antigen complex. ### Claim 2 (depends on 1) The immunoassay of claim 1, wherein the antibody or antigen binding fragment thereof is a monoclonal antibody or antigen binding fragment thereof. ### Claim 3 (depends on 2) The immunoassay of claim 2, wherein the antibody or antigen binding fragment is a capture antibody or antigen binding fragment thereof. ### Claim 4 (depends on 1) The immunoassay of claim 1, further comprising a second antibody or antigen binding fragment thereof, wherein the second antibody or antigen binding fragment thereof specifically binds to a 100 kDa glycoprotein comprising SEQ ID NO:1, but does not substantially bind to glycosylated 180 kDa CEA and to one or more linear peptides selected from the group consisting of 15 amino acids from amino acids of SEQ ID NO:2, amino acids of SEQ ID NO:3, and 15 amino acids from amino acids of SEQ ID NO:4, and wherein said antibody or antigen binding fragment binds to an epitope comprised within amino acids of SEQ ID NO:6, 7, 8, 9, 10 or 11. ### Claim 5 (depends on 4) The immunoassay of claim 4, wherein the second antibody or antigen binding fragment thereof is a monoclonal antibody or antigen binding fragment thereof. ### Claim 6 (depends on 5) The immunoassay of claim 5, wherein the second antibody or antigen binding fragment thereof is a capture antibody or antigen binding fragment thereof. ### Claim 7 (depends on 1) The immunoassay of claim 1, further comprising an additional antibody or antigen binding fragment thereof that specifically binds to the 100 kDa glycoprotein comprising SEQ ID NO:1. ### Claim 8 (depends on 7) The immunoassay of claim 7, wherein said additional antibody or antigen binding fragment thereof is labeled with a label selected from the group consisting of a radionuclide, an enzyme, a fluorescent agent and a chromophore. ### Claim 9 (depends on 8) The immunoassay of claim 8, wherein the additional antibody or antigen binding fragment thereof is a polyclonal antibody or antigen binding fragment thereof. ### Claim 10 (depends on 1) The immunoassay of claim 1, further comprising identifying the subject as at risk for cancer if the amount of the antigen in the sample is about 6.5 units/ml or greater. ### Claim 11 (depends on 1) The immunoassay of claim 1, wherein the sample is a human tissue or fluid. ### Claim 12 An immunoassay for determining whether a subject is at risk of cancer, the immunoassay comprising: a) combining an antibody or antigen binding fragment thereof with a sample from the subject wherein the antibody or antigen binding fragment thereof specifically binds to a 100 kDa glycoprotein comprising SEQ ID NO:1, but does not substantially bind to glycosylated 180 kDa CEA and to one or more linear peptides selected from the group consisting of 15 amino acids from amino acids of SEQ ID NO:2, amino acids of SEQ ID NO:3, and 15 amino acids from amino acids of SEQ ID NO:4, wherein the antibody or antigen binding fragment thereof comprises: heavy chain CDRs (HCDR1, HCDR2 and HCDR3) from a heavy chain variable region having the sequence of SEQ ID NO:119; and light chain CDRs (LCDR1, LCDR2 and LCDR3) from a light chain variable region having the sequence of SEQ ID NO:120; and b) determining the amount of the antigen in the sample by determining the amount of the antibody antigen complex. ### Claim 13 (depends on 12) The immunoassay of claim 12, wherein the antibody or antigen binding fragment thereof comprises the heavy and light chain variable regions.