Case Number 115075 - Exosome Associated Long Non-coding RNA Markers as Circulatory Cancer Biomarkers

Contact: Jill Uhl
Email: uhlje@ucmail.uc.edu
Phone: 513-558-5621

Description:  Drs. Shao-Chun Wang has discovered the use of exosome-associated long non-coding RNA HOTAIR as a circulatory biomarker in breast cancer, specifically as a prognostic marker associated with TNBC and/or advanced breast cancer, such as tumors developing resistance to anti-estrogens, and as a marker to assess therapeutic responsiveness. The invention can be used to either evaluate the prognosis of TNBC or other advanced breast cancers or to determine the therapeutic responsiveness to dual treatment by imatinib and lapatinib. Additionally, HOTAIR levels can be detected quantitatively with high sensitivity from PCR of patient blood samples.

This marker can be detected using high-sensitivity and quantitative PCR in patient blood samples to monitor tumor development as well as for prognosis. Although exosomal HOTAIR as a marker has recently been reported in rheumatoid arthritis [Song et al. 2014], its application as a biomarker in breast cancer and in response to targeted cancer treatment has not been reported. This patent application posits the use of exosome-associated long non-coding RNA HOTAIR as a circulatory biomarker in breast cancer, specifically as a prognostic marker associated with TNBC and/or advanced breast cancer, such as tumors developing resistance to anti-estrogens. Furthermore, exosomal HOTAIR can be used as a marker of therapeutic responsiveness in dual treatment by imatinib and lapatinib, which based on our own work is a novel and promising approach for cancer therapy. Thus this biomarker is expected to have a wide application in the management of breast cancer.

The present invention provides a novel non-invasive circulatory biomarker that would be useful in assessing prognosis and/or therapeutic responsiveness of TNBC tumors. Two target markets have been identified as relevant, including the oncology biomarker market and the HER2-negative breast cancer therapy market. Breast cancer is the most frequently diagnosed cancer in women worldwide, accounting for 25% of all new cancer cases in women. In 2012, nearly 1.7 million new cases of breast cancer were diagnosed. TNBC occurs in about 10% to 20% of diagnosed breast cancers. The global market for oncology biomarkers was valued at $13.16 billion in 2011 and is expected to be worth $29.78 billion in 2018. In 2013, the global HER2-negative breast cancer therapy market was valued at $1.45 billion and is projected to increase to $6.12 billion by 2023. TNBC accounts for around 10% of all HER2-negative breast cancers.

A provisional patent application has been filed.

Oncotarget, Advanced Publications 2015; "Combined inhibition of EGFR and c-ABL suppresses the growth of triple-negative breast cancer growth through inhibition of HOTAIR", Yuan-Liang Wang, et. Al.