# US 10,481,159 B2 · IL-6 signaling and breast cancer

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- Number: US 10,481,159 B2
- Document ID: US10481159B2
- Status: Granted
- Kind: B2
- Application number: 15/806,883
- Filed: 2017-11-08
- Published: 2018-05-10
- Granted: 2019-11-19
- Earliest claimed: 2016-11-09
- Assignees: City of Hope
- Applicants: City of Hope
- Inventors: Peter P. Lee
- Web page: https://patentgrep.com/patent/US10481159B2

## CPC

- G01N 33/57515: of the breast
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/6869: {Interleukin}
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- G01N 2333/4703: Regulators; Modulating activity
- G01N 2333/5412: IL-6
- G01N 2333/7155: for interleukins [IL]
- G01N 2800/54: Determining the risk of relapse
- 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)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

The disclosure provides, inter alia, methods of detecting IL-6 signaling activity in T cells in breast cancer patients, such as breast cancer patients in remission.

## Claims

### Claim 1

A method of detecting IL-6 activity in a breast cancer patient in remission, the method comprising the steps of:
(i) obtaining a biological sample comprising CD4+ T cells from the breast cancer patient in remission;
(ii) contacting the biological sample with either: (a) an IL-6 pathway detection agent capable of binding an IL-6 pathway protein, wherein the IL-6 pathway protein is phosphorylated STAT1, phosphorylated STAT3, IL-6Rα, or ADAM17, thereby forming a detectable complex; or (b) an IL-6 pathway probe capable of hybridizing an IL-6 pathway mRNA expression sequence, wherein the IL-6 pathway mRNA expression sequence is gp130; thereby forming a hybridization complex; and
(iii) detecting and/or quantifying either: (a) the detectable complex; or (b) the hybridization complex, respectively;
thereby detecting IL-6 activity in the breast cancer patient in remission.

### Claim 2 (depends on 1)

The method of claim 1, wherein the biological sample is a blood sample.

### Claim 3 (depends on 1)

The method of claim 1, wherein the biological sample is a peripheral blood sample.

### Claim 4 (depends on 1)

The method of claim 1, wherein the biological sample is peripheral blood mononuclear cell sample.

### Claim 5 (depends on 1)

The method of claim 1, wherein the CD4+ T cells are naïve CD4+ T cells.

### Claim 6 (depends on 1)

The method of claim 1, wherein the IL-6 pathway protein is IL-6Rα.

### Claim 7 (depends on 1)

The method of claim 1, wherein the IL-6 pathway protein is ADAM 17.

### Claim 8 (depends on 1)

The method of claim 1, wherein the IL-6 pathway protein is phosphorylated STAT1.

### Claim 9 (depends on 1)

The method of claim 1, wherein the IL-6 pathway protein is phosphorylated STAT3.

### Claim 10 (depends on 1)

The method of claim 1, further comprising the steps of: (i) monitoring the patient for breast cancer relapse; (ii) administering to the patient an anti-cancer agent; or (iii) monitoring the patient for breast cancer relapse and administering to the patient an anti-cancer agent.

### Claim 11 (depends on 1)

The method of claim 1, wherein the IL-6 pathway detection agent comprises: (i) an antibody; (ii) an antibody bound to an enzyme; (iii) a primary antibody bound to a secondary antibody that is bound to an enzyme; (iv) biotin and streptavidin; (v) biotin streptavidin, and an enzyme; (vi) biotin and avidin, or (vii) biotin, avidin, and an enzyme.