# US 12,767,990 B2 · EPLIN as a biomarker for cancer

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- Number: US 12,767,990 B2
- Document ID: US12767990B2
- Status: Granted
- Kind: B2
- Application number: 17/917,902
- Filed: 2021-04-09
- Published: 2023-05-04
- Granted: 2026-10-20
- Earliest claimed: 2020-04-09
- Assignees: Thestra Oy
- Applicants: Thestra Oy
- Inventors: Sami Ventelä; Jukka Westermarck
- Web page: https://patentgrep.com/patent/US12767990B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/57515: of the breast
- G01N 33/57535: of the large intestine, e.g. colon, rectum or anus
- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- G01N 33/57595: {involving intracellular compounds}
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- 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
- 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

The present invention relates to EPLIN as a biomarker for cancer and particularly small-size (T1/T2N0 and/or stage I/II) cancer. Thus, the invention provides use of EPLIN and an in vitro method of prognosing cancer or diagnosing aggressive cancer in a subject on the basis of the expression level of EPLIN. Also provided is a method for selecting treatment for cancer or predicting response to treatment. Also provided is a kit for use in said methods.

## Claims

### Claim 1

A method of treating HNSCC cancer in a subject, the method comprising:
a) assaying a HNSCC sample obtained from said subject for expression level of EPLIN,
b) selecting as a treatment either:
(i) monotherapy with surgery when the expression of EPLIN is non-increased or decreased as compared to a relevant control level; or
(ii) chemotherapy in combination with dissection, radiotherapy, or both dissection and radiotherapy, when the expression of EPLIN is increased as compared to the relevant control level; and
c) administering the selected treatment to the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the relevant control level is the expression level of EPLIN in a non-diseased normal control or the relevant control level is determined from a sample collected from said subject treated for cancer before the treatment.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the chemotherapy is chemotherapy with an EGFR inhibitor being one or more selected from Erlotinib, AZD9291, Afatinib, Cetuximab, AZD8931, Gefitinib and Neratinib.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the cancer is T1/T2N0 and/or I/II cancer.

### Claim 5 (depends on 1)

The method according to claim 1, wherein a sample is obtained from the cancer tumor and the healthy tissue area adjacent to the tumor, and expression level of EPLIN is determined from both samples.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the expression level of EPLIN is determined at mRNA, cDNA, or protein level.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the method comprises the use of a kit comprising one or more reagents that specifically detect EPLIN.

### Claim 8 (depends on 1)

The method according to claim 1, wherein EPLIN is assayed as expression level of total EPLIN, EPLIN alpha or EPLIN beta or any combination thereof.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the expression level of total EPLIN and EPLIN alpha or EPLIN beta is assayed to determine a ratio between total EPLIN and EPLIN alpha or EPLIN beta.