# US 9,753,038 B2 · Method for detecting cancer via measurement of caprin-1 expression level

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- Number: US 9,753,038 B2
- Document ID: US9753038B2
- Status: Granted
- Kind: B2
- Application number: 14/415,090
- Filed: 2013-07-19
- Published: 2015-07-02
- Granted: 2017-09-05
- Earliest claimed: 2012-07-19
- Assignees: Toray Industries, Inc.
- Applicants: Toray Industries, Inc.
- Inventors: Takayoshi Ido; Fumiyoshi Okano
- Web page: https://patentgrep.com/patent/US9753038B2

## CPC

- G01N 33/57595: {involving intracellular compounds}
- C07K 14/4738: {Cell cycle regulated proteins, e.g. cyclin, CDC, INK-CCR (cell cycle dependent kinases C12N9/12)}
- C07K 14/4748: {Tumour specific antigens; Tumour rejection antigen precursors [TRAP], e.g. MAGE}
- C07K 16/18: against material from animals or humans
- C07K 16/30: from tumour cells
- G01N 33/5759: {involving compounds localised on the membrane of tumour or cancer cells}
- G01N 33/6872: {Intracellular protein regulatory factors and their receptors, e.g. including ion channels}
- 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
- G01N 2333/4703: Regulators; Modulating activity
- 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

This invention provides: a method for detecting a cancer, comprising measuring the expression of a polypeptide having binding reactivity through antigen-antibody reaction with an antibody against CAPRIN-1 having the amino acid sequence shown in any even-numbered SEQ ID NO of SEQ ID NOs: 2 to 30 in the Sequence Listing in a biological sample; a method for detecting a cancer which involves determining the presence and the amount of CAPRIN-1 in a sample of a cancer patient in order to determine the administration of a CAPRIN-1-targeting drug to the cancer patient; and a drug and a kit for the diagnosis of a cancer, comprising an anti-CAPRIN-1 antibody.

## Claims

### Claim 1

A method for detecting a cancer in an individual, comprising:
detecting an expression level of CAPRIN-1 in a biological sample from the individual above that of a healthy subject through an antigen-antibody reaction using
a monoclonal antibody having a heavy chain variable region comprising the amino acid sequence shown in SEQ ID NO: 70 and a light chain variable region comprising the amino acid sequence shown in SEQ ID NO: 71, or an antigen-binding fragment thereof.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the CAPRIN-1 to be detected is:
(a) a polypeptide consisting of the amino acid sequence shown in any even-numbered SEQ ID NO of SEQ ID Nos: 2 to 30 in the Sequence Listing, or
(b) a polypeptide consisting of 85% or higher sequence identity to the polypeptide consisting of the amino acid sequence shown in any even-numbered SEQ ID NO of SEQ ID Nos: 2 to 30 in the Sequence Listing.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the biological sample is derived from a human, a dog, or a cat.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the biological sample is derived from a dog, and the CAPRIN-1 to be detected consists of the amino acid sequence shown in SEQ ID NO: 6, 8, 10, 12, or 14.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the biological sample is derived from a human, and the CAPRIN-1 to be detected consists of the amino acid sequence shown in SEQ ID NO: 2 or 4.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the detection of the expression level of CAPRIN-1 is carried out using an immunological assay method.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the immunological assay method is ELISA and/or an immunohistochemical staining method.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the biological sample is a body fluid, a tissue, or a cell.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the cancer is at least one cancer selected from the group consisting of breast cancer, brain tumor, esophagus cancer, stomach cancer, lung cancer, liver cancer, kidney cancer, thyroid gland cancer, spleen cancer, pancreas cancer, large bowel cancer, skin cancer, ovary cancer, uterus cancer, prostate cancer, bladder cancer, testis cancer, osteosarcoma, and fibrosarcoma.

### Claim 10 (depends on 2)

The method according to claim 2, wherein the biological sample is derived from a human, a dog, or a cat.

### Claim 11 (depends on 2)

The method according to claim 2, wherein the biological sample is derived from a dog, and the CAPRIN-1 to be detected consists of the amino acid sequence shown in SEQ ID NO: 6, 8, 10, 12, or 14.

### Claim 12 (depends on 3)

The method according to claim 3, wherein the biological sample is derived from a dog, and the CAPRIN-1 to be detected consists of the amino acid sequence shown in SEQ ID NO: 6, 8, 10, 12, or 14.

### Claim 13 (depends on 2)

The method according to claim 2, wherein the biological sample is derived from a human, and the CAPRIN-1 to be detected consists of the amino acid sequence shown in SEQ ID NO: 2 or 4.

### Claim 14 (depends on 3)

The method according to claim 3, wherein the biological sample is derived from a human, and the CAPRIN-1 to be detected consists of the amino acid sequence shown in SEQ ID NO: 2 or 4.

### Claim 15

A method for selecting an individual-specific therapeutic drug for a cancer, comprising:
detecting an expression level of CAPRIN-1 in a biological sample from the individual using a monoclonal antibody having a heavy chain variable region comprising the amino acid sequence SEQ ID NO: 70 and a light chain variable region comprising the amino acid sequence shown in SEQ ID NO: 71, or an antigen-binding fragment thereof; and,
if the expression level is statistically significantly higher than that of a healthy individual, selecting a CAPRIN-1-targeting drug as a therapeutic drug for the cancer suitable for administration to the individual from which the biological sample was derived.

### Claim 16 (depends on 15)

The method for selecting an individual-specific therapeutic drug for a cancer according to claim 15, wherein the CAPRIN-1-targeting drug is an antibody having immunological reactivity with CAPRIN-1, or an antigen-binding fragment thereof.

### Claim 17

A method for detecting CAPRIN-1 in an individual comprising:
detecting CAPRIN-1 in a biological sample from the individual through an antigen-antibody reaction using a monoclonal antibody having a heavy chain variable region comprising the amino acid sequence SEQ ID NO: 70 and a light chain variable region comprising the amino acid sequence shown in SEQ ID NO: 71, or an antigen-binding fragment thereof.
