# US 8,119,355 B2 · Biomarkers for cancer sensitivity and uses thereof

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- Number: US 8,119,355 B2
- Document ID: US8119355B2
- Status: Granted
- Kind: B2
- Application number: 12/723,113
- Filed: 2010-03-12
- Published: 2010-07-08
- Granted: 2012-02-21
- Earliest claimed: 2006-10-23
- Assignees: The UAB Research Foundation
- Inventors: Robert P. Kimberly; Tong Zhou; Takeshi Isoyama
- Web page: https://patentgrep.com/patent/US8119355B2

## CPC

- G01N 33/5011: {for testing antineoplastic activity}
- A61P 35/00: Antineoplastic agents
- G01N 33/5088: {of vertebrates}
- G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites}
- G01N 2333/4703: Regulators; Modulating activity
- G01N 2333/908: acting on hydrogen peroxide as acceptor (1.11)
- G01N 2333/91225: with a carboxyl group as acceptor (2.7.2)
- G01N 2333/988: Lyases (4.), e.g. aldolases, heparinase, enolases, fumarase
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Disclosed herein are biomarkers and uses thereof for evaluating anti-cancer efficacy and sensitivity.

## Claims

### Claim 1

A method of predicting sensitivity of a cancer cell to a first anti-cancer agent comprising:
(a) contacting the cancer cell with an effective amount of the anti-cancer agent, wherein the anti-cancer agent comprises TRA-8 or an antibody having the same epitope specificity as TRA-8; and
(b) evaluating the release by the cell of one or more biomarkers selected from the group consisting of fructose-bisphosphate aldolase A (ALDOA), phosphoglycerate kinase 1 (PGK1), peroxiredoxin 1 (PRDX1), and colfilin 1 (COF1), an increase in release by the contacted cell compared to a control cell indicating that the cancer cell is sensitive to the agent.

### Claim 2 (depends on 1)

The method of claim 1, wherein the cancer cell is contacted in vivo.

### Claim 3 (depends on 1)

The method of claim 1, wherein the cancer cell is contacted in vitro.

### Claim 4 (depends on 1)

The method of claim 1, wherein the antibody having the same epitope specificity as TRA-8 is a humanized version of TRA-8.

### Claim 5

A method of determining an effective dose for an anti-cancer agent comprising:
(a) contacting one or more cancer cells with a plurality of dosages of the anti-cancer agent under conditions that allow cellular release of one or more biomarkers selected from the group consisting of fructose-bisphosphate aldolase A (ALDOA), phosphoglycerate kinase 1 (PGK1), peroxiredoxin 1 (PRDX1), and colfilin 1 (COF1), and histone H4, wherein the anti-cancer agent comprises TRA-8 or an antibody having the same epitope specificity as TRA-8; and
(b) detecting the release at each dosage, higher release rates indicating an effective dosage.

### Claim 6 (depends on 5)

The method of claim 5, wherein the antibody having the same epitope specificity as TRA-8 is a humanized version of TRA-8.

### Claim 7 (depends on 5)

The method of claim 5, wherein at least one cell is contacted with more than one dosage.

### Claim 8 (depends on 5)

The method of claim 5, wherein each cell is contacted with only one dosage.

### Claim 9 (depends on 1)

The method of claim 1, wherein the method further comprises evaluating the release by the cell of histone H4, an increase in release by the contacted cell compared to a control cell indicating that the cancer cell is sensitive to the agent.