# US 11,442,065 B2 · Marker for gastrointestinal tumors

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- Number: US 11,442,065 B2
- Document ID: US11442065B2
- Status: Granted
- Kind: B2
- Application number: 16/834,981
- Filed: 2020-03-30
- Published: 2020-12-03
- Granted: 2022-09-13
- Earliest claimed: 2019-05-30
- Assignees: Rhode Island Hospital
- Applicants: Rhode Island Hospital
- Inventors: Wentian Yang; Lijun Wang; Douglas C. Moore
- Web page: https://patentgrep.com/patent/US11442065B2

## CPC

- G01N 33/5753: of the stomach or small intestine
- G01N 33/56966: {Animal cells}
- 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}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

The invention provides that OSTERIX (a.k.a. SP7) is a marker for gastrointestinal stem cells and that OSTERIX is expressed widely and at elevated levels in human gastrointestinal tumors.

## Claims

### Claim 1

A method for selectively treating gastrointestinal cancer in a patient in need thereof, comprising the steps of:
(a) selecting a patient for treatment with an anticancer agent;
(b) providing a series of biological samples from the subject over a time period;
(c) analyzing the series of biological samples to determine the amount of OSTERIX marker in the subject's biological samples;
(d) determining the change in the amount of OSTERIX marker in the biological samples; and
(e) determining based upon the change whether to initiate or continue the prophylaxis or therapy of gastrointestinal cancer, and
(f) administering a therapeutically effective amount of an anticancer agent or method to the patient,
wherein the anticancer agent or method is selected from the group consisting of:
(i) non-drug treatments selected from the group consisting of Radio Frequency Ablation (RFA) and Hepatic Arterial Chemoembolization (HACE);
(ii) adjuvant or neoadjuvant therapy selected from the group consisting of imatinib, sunitinib, regorafenib, and avapritinib;
(iii) EGFR inhibitors selected from the group consisting of cetuximab, panitumumab, and necitumumab;
(iv) tyrosine kinase inhibitors selected from the group consisting of erlotinib, geftinib, afatinib, lapatinib, and osimertinib;
(v) cetuximab, either alone or combination with 5-FU, leucovorin, and irinotecan;
(vi) panitumumab;
(vii) regorafenib;
(viii) trifluridine/tipiracil; and
(ix) immune checkpoint inhibitors selected from the group consisting of nivolumab and ipilimumab.

### Claim 2 (depends on 1)

The method of claim 1, wherein the selecting a patient for treatment with an anticancer agent comprises identifying gastrointestinal stem cells in a gastrointestinal sample.

### Claim 3 (depends on 1)

The method of claim 1, wherein the selecting a patient for treatment with an anticancer agent comprises identifying gastrointestinal stem cells in a gastrointestinal sample and analyzing the gastrointestinal sample to determine the amount of OSTERIX marker.

### Claim 4 (depends on 1)

The method of claim 1, wherein the selecting a patient for treatment with an anticancer agent comprises identifying gastrointestinal stem cells in a gastrointestinal sample by the expression of the OSTERIX marker in the cells in the gastrointestinal sample.

### Claim 5 (depends on 1)

The method of claim 1, wherein the method for selectively treating gastrointestinal cancer in a patient further comprises the step of:
(g) determining whether to continue prophylaxis or treatment of gastrointestinal cancer in the subject.