Tox3 as a biomarker for breast cancer

Abstract

The invention provides compositions and methods for detecting and/or modulating TOX3 gene expression and/or biological activity. Such compositions and methods find utility in the detection and/or treatment of certain subsets of cancers, e.g. breast cancer. In particular, the inventive compositions and methods are drawn to production and use of anti-TOX3 antibodies and TOX3 nucleic acids for both detection and modulation of TOX3. The invention also provides for pharmaceutical compositions and methods for the modulation of TOX3 in a subject in need thereof. Further aspects of the invention relate to transgenic mice that either overexpress or inducibly express TOX3.

1 - 21 . (canceled) 
     
     
         22 . An isolated monoclonal antibody capable of binding to human TOX3. 
     
     
         23 . The isolated antibody of  claim 22 , wherein the antibody binds to human TOX3 within the N-terminus of TOX3. 
     
     
         24 . The isolated antibody of  claim 22 , wherein the isolated antibody is a rabbit monoclonal antibody. 
     
     
         25 . The isolated antibody of  claim 24 , wherein the isolated antibody binds to 5 to 45 consecutive amino acids of SEQ ID NO: 2. 
     
     
         26 . The isolated antibody of  claim 24 , wherein the isolated antibody binds to 45 to 90 consecutive amino acids of SEQ ID NO: 2. 
     
     
         27 . The isolated antibody of  claim 22 , wherein the isolated antibody preferentially binds to cells obtained from tumor tissue compared to non-tumor tissue. 
     
     
         28 . The isolated antibody of  claim 25 , wherein the tumor tissue is derived from subtypes of breast cancer selected from the group consisting of: sub luminal A (lumA), luminal B (lumB), ErbB2-enriched, basal (basL), normal-breast-like (normL), molecular apocrine (mApo) and luminal C (lumC). 
     
     
         29 . The isolated antibody of  claim 28 , wherein the isolated antibody preferentially binds to cells obtained from tumor tissue derived from one or more subtype of breast cancer compared to a different subtype of breast cancer. 
     
     
         30 . A method of treating a disease in a subject in need thereof, comprising:
 providing a pharmaceutical composition comprising the isolated antibody of  claim 22 , and a pharmaceutically acceptable carrier; and   administering the pharmaceutical composition to the subject, whereby the disease is treated.   
     
     
         31 . The method of  claim 30 , wherein the disease is selected from a subtype of breast cancers. 
     
     
         32 . The method of  claim 31 , wherein the subtype of breast cancer comprises one or more of the subtypes selected from the group consisting of: sub luminal A (lumA), luminal B (lumB), ErbB2-enriched, basal (basL), normal-breast-like (normL), molecular apocrine (mApo) and luminal C (lumC). 
     
     
         33 . A pharmaceutical composition, comprising:
 a quantity of an isolated monoclonal antibody capable of binding to human TOX3; and   a pharmaceutically acceptable carrier.   
     
     
         34 . The isolated antibody of  claim 33 , wherein the antibody binds to human TOX3 within the N-terminus of TOX3. 
     
     
         35 . The isolated antibody of  claim 33 , wherein the isolated antibody is a rabbit monoclonal antibody. 
     
     
         36 . The isolated antibody of  claim 34 , wherein the isolated antibody binds to 5 to 45 consecutive amino acids of SEQ ID NO: 2. 
     
     
         37 . The isolated antibody of  claim 34 , wherein the isolated antibody binds to 45 to 90 consecutive amino acids of SEQ ID NO: 2.