IP Library Granted Patent US 8,697,373
Granted Patent B2
US 8,697,373 · App. 12/444,007 · Granted Apr 15, 2014

Reagents and methods for use in cancer diagnosis, classification and therapy

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Quick Facts
Patent No.
US 8,697,373
App. No.
12/444,007
Granted
Apr 15, 2014
Kind
B2
Abstract

Methods and reagents for classifying HER2+ breast tumors and for identifying new HER2+ breast tumor classes and subclasses. Methods for correlating tumor class or subclass with therapeutic regimen or outcome, for identifying appropriate (new or known) therapies for particular classes or subclasses, and for predicting outcomes based on class or subclass. New therapeutic agents and methods for the treatment of HER2+ breast cancer.

Claims (27)

1. A method comprising steps of:

obtaining a tumor sample from a patient having an HER2+ breast tumor;

contacting the tumor sample with a first antibody directed to HTF9C (Hpall tiny fragments locus 9C); and

assessing the patient's likely prognosis based upon binding of the first antibody to the tumor sample, wherein binding of the first antibody correlates with a higher likelihood that the patient will have a poor outcome.

2. The method of claim 1 further comprising:

providing a positive control sample; and

contacting the positive control sample with a first antibody directed to HTF9C (Hpall tiny fragments locus 9C), wherein the step of assessing the patient's likely prognosis comprises a step of comparing the binding of the first antibody to the tumor sample with the binding of the first antibody to the positive control sample.

3. The method of claim 1 , wherein the first antibody is a monoclonal antibody.

4. The method of claim 1 further comprising:

determining from the binding of the first antibody that the patient's prognosis is poor and administering a breast cancer therapeutic to the patient.

5. The method of claim 4 , wherein the breast cancer therapeutic is Trastuzumab.

6. The method of claim 1 further comprising:

confirming the breast tumor is positive for HER2.

7. The method of claim 6 , wherein the breast tumor is confirmed to be positive for HER2 by imunohistochemistry.

8. The method of claim 6 , wherein the breast tumor is confirmed to be positive for HER2 by in situ hybridization.

9. The method of claim 1 further comprising:

contacting the tumor sample with a second antibody directed to estrogen receptor, wherein in the step of assessing, the patient's likely prognosis is assessed based upon binding of the first and second antibodies to the tumor sample, wherein binding of the second antibody correlates with a higher likelihood that the patient will have a good outcome.

10. The method of claim 9 , wherein binding of the second antibody correlates with a lower likelihood that the patient will have a recurrence.

11. The method of claim 9 , wherein binding of the second antibody correlates with a higher likelihood that the patient will survive for a period of time.

12. The method of claim 1 , wherein binding of the first antibody correlates with a higher likelihood that the patient will have a recurrence.

13. The method of claim 1 , wherein binding of the first antibody correlates with a lower likelihood that the patient will survive for a period of time.

14. A method comprising steps of:

obtaining a tumor sample from a patient having an HER2+ breast tumor;

contacting the tumor sample with a first antibody directed to HTF9C (Hpall tiny fragments locus 9C); and

classifying the HER2+ breast tumor based upon binding or nonbinding of the first antibody to HTF9C (Hpall tiny fragments locus 9C) in the tumor sample.

15. The method of claim 14 further comprising:

contacting the tumor sample with a second antibody directed to estrogen receptor, wherein in the step of classifying, the HER2+ breast tumor is classified based upon binding or nonbinding of the first antibody to HTF9C (Hpall tiny fragments locus 9C) in the tumor sample and based on binding or nonbinding of the second antibody to estrogen receptor in the tumor sample.

Assignments (8)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS Recorded Jun 28, 2019
From: REGIONS BANK, AS COLLATERAL AGENT
To: CLARIENT DIAGNOSTIC SERVICES, INC.
Reel/Frame 049629/0243 →
RELEASE OF SECURITY INTEREST Recorded Dec 23, 2016
From: WELLS FARGO BANK, NATIONAL ASSOCIATION
To: CLARIENT, INC.; CLARIENT DIAGNOSTIC SERVICES, INC.
Reel/Frame 040759/0857 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Dec 23, 2016
From: CLARIENT DIAGNOSTIC SERVICES, INC.
To: REGIONS BANK, AS COLLATERAL AGENT
Reel/Frame 041182/0700 →
RELEASE OF SECURITY INTEREST Recorded Dec 22, 2016
From: AB PRIVATE CREDIT INVESTORS LLC, AS COLLATERAL AGENT
To: NEOGENOMICS LABORATORIES, INC.; NEOGENOMICS, INC.; CLARIENT, INC.; CLARIENT DIAGNOSTIC SERVICES, INC.; PATH LABS, LLC
Reel/Frame 040754/0293 →
SECURITY INTEREST Recorded Jan 5, 2016
From: NEOGENOMICS LABORATORIES, INC.; NEOGENOMICS, INC.; CLARIENT, INC.; CLARIENT DIAGNOSTIC SERVICES, INC.; PATH LABS, LLC
To: AB PRIVATE CREDIT INVESTORS LLC, AS COLLATERAL AGENT
Reel/Frame 037408/0921 →
SECURITY INTEREST Recorded Dec 30, 2015
From: CLARIENT, INC.; CLARIENT DIAGNOSTIC SERVICES, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 037386/0565 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2012
From: APPLIED GENOMICS, INC.
To: CLARIENT DIAGNOSTIC SERVICES, INC.
Reel/Frame 028468/0455 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 2, 2009
From: RING, BRIAN Z.; ROSS, DOUGLAS T.; SEITZ, ROBERT S.
To: APPLIED GENOMICS, INC.
Reel/Frame 022908/0604 →