2019-06-018 - Biomarker-CDx - Novel biomarker for precision medicine

Biomarker-CDx

2019-06-018

Novel predictive biomarker detectable through immunohistochemistry. Used to identify cancer patients with a TGFβ-activated microenvironment in colorectal cancer (CRC) and other tumor types

IRB Barcelona adheres to the 3 pillars of ESG, environmental, social and governance, to perform all of their projects with the highest standards.

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Problem: CRC is the third most-diagnosed cancer in EU and USA. Diagnosed prevalent cases in 2018 were 2,741 million being stage III and IV of the disease 45% of all cases and expected to reach 3,152 million by 2025. According to Globaldata, the CRC market size in 2018 in the 8MM was 8,552 USD million with a CAGR of 0.03% (2015- 2025). Not only for CRC, but novel therapies targeting TGFβ signaling are in clinical trials for a variety of cancers. One of the important needs for effective TGFβ inhibitors treatment is the use of predictive biomarkers for patient selection, in order to define in what kind of tumor microenvironment TGFβ signaling inhibition may be more beneficial. Solution: Our new biomarker can identify patients responsive to TGFβ signaling inhibition

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Biomarker CDx project aims to develop a novel predictive and diagnostic tool, by using immunohistochemistry, for its use as a prognosis test as well as for personalized medicine purposes (companion diagnostic). The new biomarker will be useful to identify cancer patients with a TGFβ-activated microenvironment in colorectal cancer (CRC) and other tumor types. Our biomarker is currently patent protected (Patent: NOVEL PROGNOSIS, PREDICTIVE AND RESPONSE BIOMARKER, September 2019).

Our new biomarker will help doctors and their patients to make informed and individualized treatment decisions, based on the risk of the patient to develop recurrent CRC and their responsiveness to new treatments, helping to save lives. With more than one million new cases of CRC diagnosed per year, the possibility of sparing unnecessary chemotherapeutic treatments would represent substantial savings for health care systems and will prevent unnecessary suffering to patients.

We have identified one biomarker that is a secreted glycoprotein, the expression of which is strongly associated with poor prognosis in multiple tumor types. For example, overexpression of our biomarker has been associated with increased aggressiveness in lung cancer, with EMT in ovarian cancer, as well as with a poor prognosis in pancreatic adenocarcinoma. We have also demonstrated that cancer patient samples with high mRNA expression of our biomarker, exhibited elevated levels of public TGF-beta associated signatures of more than 1000 genes in total((Calon et al., Cancer Cell 2012; Calon et al., Nature Genetics 2015)). Interestingly, a high biomarker score was also shown to identify most of CRC tumors classified under CMS4, a CRC molecular subtype associated with prominent TGFβ activation according to the consensus molecular subtypes (CMSs) classification (Guinney et al., Nature Medicine, 2015). Therefore, determining our biomarker expression could be a simple method to identify patients bearing CMS4 tumors. In addition, we have demonstrated that our biomarker was capable of identifying tumors presenting a TGFβ activated TME, and thus likely to benefit from a therapy inhibiting the TGFβ signaling pathway.

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Our biomarker is a simple method what could facilitate the transition from current clinical practice to precision medicine, making it attractive to many companies developing TGF-beta inhibitors.