# US 10,308,709 B2 · Anti-GP73 monoclonal antibodies and methods of obtaining the same

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- Number: US 10,308,709 B2
- Document ID: US10308709B2
- Status: Granted
- Kind: B2
- Application number: 15/290,762
- Filed: 2016-10-11
- Published: 2017-04-06
- Granted: 2019-06-04
- Earliest claimed: 2013-03-15
- Assignees: Abbott Laboratories
- Applicants: Abbott Laboratories
- Inventors: Bailin Tu; Robert N. Ziemann; Bryan C. Tieman; Philip M. Hemken; Carol S. Ramsay; Carolyn J. Strobel; David J. Hawksworth; Larry G. Birkenmeyer; Cheng Zhao; Susan E. Brophy; Barry L. Dowell; Anthony S. Muerhoff
- Web page: https://patentgrep.com/patent/US10308709B2

## CPC

- C07K 16/18: against material from animals or humans
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 35/00: Antineoplastic agents
- G01N 33/57525: of the liver or pancreas
- G01N 33/6893: {related to diseases not provided for elsewhere}
- C07K 2317/21: from primates, e.g. man
- 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]
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- G01N 2333/47: Assays involving proteins of known structure or function as defined in the subgroups
- G01N 2800/085: Liver diseases, e.g. portal hypertension, fibrosis, cirrhosis, bilirubin
- G01N 2800/50: Determining the risk of developing a disease
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

Disclosed herein are antibodies and methods of using said antibodies to detect Golgi protein 73 (GP73) and fucosylated GP73 in a sample.

## Claims

### Claim 1

A method for determining GP73 concentration in a test sample, the method comprising:
(a) contacting the test sample with at least one capture antibody comprising (i) a variable heavy chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO: 18, a CDR2 comprising the amino acid sequence of SEQ ID NO: 19, and a CDR3 comprising the amino acid sequence of SEQ ID NO: 20, and (ii) a variable light chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO: 22, a CDR2 comprising the amino acid sequence of SEQ ID NO: 23, and a CDR3 comprising the amino acid sequence of SEQ ID NO: 24, which binds to an epitope on GP73 comprising the amino acid sequence of SEQ ID NO: 102 to form a capture antibody-GP73 antigen complex;
(b) contacting the capture antibody-GP73 antigen complex with at least one detection antibody comprising a detectable label, wherein the detection antibody comprises (i) a variable heavy chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO:26, a CDR2 comprising the amino acid sequence of SEQ ID NO:27, and a CDR3 comprising the amino acid sequence of SEQ ID NO:28, and (ii) a variable light chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO:30, a CDR2 comprising the amino acid sequence of SEQ ID NO:31, and a CDR3 comprising the amino acid sequence of SEQ ID NO:32 which binds to an epitope on GP73 that is not bound by the capture antibody and forms a capture antibody-GP73 antigen-detection antibody complex; and
(c) determining the GP73 concentration in the test sample based on the signal generated by the detectable label in the capture antibody-GP73 antigen-detection antibody complex formed in (b).

### Claim 2 (depends on 1)

The method of claim 1, further comprising comparing the signal generated by the detectable label as a direct or indirect indication of the GP73 concentration in the test sample to a signal generated as a direct or indirect indication of the GP73 concentration in a control or calibrator.

### Claim 3 (depends on 2)

The method of claim 2, wherein the GP73 concentration in the test sample is used to determine or assess whether a subject has or is at risk of developing liver disease.

### Claim 4 (depends on 1)

The method of claim 1, wherein the capture antibody comprises a variable heavy chain domain comprising the amino acid sequence of SEQ ID NO: 17 and a variable light chain domain region comprising the amino acid sequence of SEQ ID NO: 21.

### Claim 5 (depends on 1)

The method of claim 1, wherein the detection antibody comprises a variable heavy chain domain comprising the amino acid sequence of SEQ ID NO: 25 and a variable light chain domain region comprising the amino acid sequence of SEQ ID NO: 29.