# US 2025/0085286 A1 · Collagen Type XXII Assay

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- Number: US 2025/0085286 A1
- Document ID: US20250085286A1
- Status: Published application
- Kind: A1
- Application number: 18/708,242
- Filed: 2022-11-07
- Published: 2025-03-13
- Earliest claimed: 2021-11-08
- Assignees: Nordic Biioscience A/S
- Applicants: Nordic Biioscience A/S
- Inventors: Emilie Albrecht Madsen; Jeppe Thorlacius-Ussing; Nicholas Willumsen; Morten Asser Karsdal
- Web page: https://patentgrep.com/patent/US20250085286A1

## CPC

- G01N 33/57525: of the liver or pancreas
- G01N 33/57585: {involving compounds identifiable in body fluids}
- C07K 16/18: against material from animals or humans
- G01N 33/6893: {related to diseases not provided for elsewhere}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- 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
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- G01N 2333/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- 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 relates to immunoassays, in particular immunoassays for detecting and/or monitoring cancer in a patient, and to monoclonal antibodies and immunoassay kits for use in carrying out the immunoassays.

## Claims

### Claim at position 1

1: A method of immunoassay for detecting and/or monitoring cancer in a patient, the method comprising:
i) contacting a sample from a patient with a monoclonal antibody that specifically binds to a C-terminus amino acid sequence AARPGNVKGP (SEQ ID No. 1); and
ii) detecting and determining the amount of binding between said monoclonal antibody and peptides in the sample.

### Claim at position 2 (depends on 1)

2: The method of claim 1, wherein the method further comprises:
iii) correlating said amount of binding of said monoclonal antibody as determined in step (ii) with values associated with normal healthy subjects, and/or with values associated with known disease severity, and/or with values obtained from said patient at a previous time point, and/or with a predetermined cut-off value.

### Claim at position 3 (depends on 1)

3: The method of claim 1, wherein the cancer is bladder cancer, breast cancer, colorectal cancer, head and neck cancer, kidney cancer, lung cancer, melanoma, ovarian cancer, pancreatic cancer, prostate cancer, or stomach cancer.

### Claim at position 4 (depends on 1)

4: The method of claim 1, wherein the cancer is pancreatic cancer.

### Claim at position 5 (depends on 4)

5: The method of claim 4 further comprising providing a prognosis of overall survival, wherein an amount of binding of said monoclonal antibody as determined in step (ii) above the median value associated with known pancreatic cancer patients is associated with poor overall survival.

### Claim at position 6 (depends on 1)

6: The method of claim 1, wherein the monoclonal antibody does not specifically bind to an elongated version of said C-terminus amino acid sequence which is AARPGNVKGPA (SEQ ID No. 3).

### Claim at position 7 (depends on 1)

7: The method of claim 1, wherein the monoclonal antibody does not specifically bind to a truncated version of said C-terminus amino acid sequence which is AARPGNVKG (SEQ ID No. 4).

### Claim at position 8 (depends on 1)

8: The method of claim 1, wherein the monoclonal antibody is raised against a synthetic peptide having the C-terminus amino acid sequence AARPGNVKGP (SEQ ID No. 1).

### Claim at position 9 (depends on 1)

9: The method of claim 1, wherein the sample is a biofluid sample selected from blood, serum or plasma.

### Claim at position 10 (depends on 1)

10: The method of claim 1, wherein the immunoassay is a competition assay or a sandwich assay.

### Claim at position 11 (depends on 1)

11: The method of claim 1, wherein the immunoassay is a radio-immunoassay or an enzyme-linked immunosorbent assay.

### Claim at position 12

12: An immunoassay kit comprising a monoclonal antibody that specifically binds to a C-terminus amino acid sequence AARPGNVKGP (SEQ ID No. 1), and at least one of;
a streptavidin coated well plate;
a biotinylated peptide Biotin-L-AARPGNVKGP (SEQ ID No. 15), wherein L is an optional linker;
a secondary antibody for use in a sandwich immunoassay;
a calibrator protein comprising the C-terminus amino acid sequence AARPGNVKGP (SEQ ID No. 1);
an antibody biotinylation kit;
an antibody HRP labelling kit;
an antibody radiolabelling kit; or
an assay visualisation kit.

### Claim at position 13 (depends on 12)

13: The immunoassay kit of claim 12, wherein the monoclonal antibody does not specifically bind to an elongated version of said C-terminus amino acid sequence which is AARPGNVKGPA (SEQ ID No. 3).

### Claim at position 14 (depends on 12)

14: The immunoassay kit of claim 12, wherein the monoclonal antibody does not specifically bind to a truncated version of said C-terminus amino acid sequence which is AARPGNVKG (SEQ ID No. 4).

### Claim at position 15 (depends on 12)

15: The immunoassay kit of claim 12, wherein the monoclonal antibody is raised against a synthetic peptide having the C-terminus amino acid sequence AARPGNVKGP (SEQ ID No. 1).

### Claim at position 16

16: A monoclonal antibody that specifically binds to a C-terminus amino acid sequence AARPGNVKGP (SEQ ID No. 1).

### Claim at position 17 (depends on 16)

17: The monoclonal antibody of claim 16, wherein the monoclonal antibody does not specifically bind to an elongated version of said C-terminus amino acid sequence which is AARPGNVKGPA (SEQ ID No. 3).

### Claim at position 18 (depends on 16)

18: The monoclonal antibody of claim 16, wherein the monoclonal antibody does not specifically bind to a truncated version of said C-terminus amino acid sequence which is AARPGNVKG (SEQ ID No. 4).

### Claim at position 19 (depends on 16)

19: The monoclonal antibody of claim 16, wherein the monoclonal antibody is raised against a synthetic peptide having the C-terminus amino acid sequence AARPGNVKGP (SEQ ID No. 1).
