IntegraGen Announces Publication in Oncotarget Showing Association of miR-31-3p Expression Levels with Progression-Free Survival in Metastatic Colorectal Cancer

Regulatory News:

INTEGRAGEN (Paris:ALINT), a company specializing in the transformation of data from biological samples into genomic information and diagnostic tools for oncology, today announced that results from an analysis of miR-31-3p expression in tumor samples from patients enrolled in the NEW EPOC clinical trial have been published online in Oncotarget. The paper entitled "Association between miR-31- 3p expression and cetuximab efficacy in patients with KRAS wild-type metastatic colorectal cancer: a post-hoc analysis of the New EPOC trial” confirms the relationship between miR-31-3p expression and the efficacy of anti-EGFR treatment.

"This publication confirms that analyzing miR-31-3p expression levels in patients with RAS wild-type metastatic colorectal cancer can be used as a complementary diagnostic tool to help identify patients who will benefit from targeted anti-EGFR therapy,” stated study co-author Prof. John Bridgewater a Medical Oncologist at University College London Cancer Institute and an Investigator for the New EPOC Study. "We are extremely pleased to be able to continue to publish clinical data from the New EPOC trial which provides clinicians with additional insight on tailoring therapeutic approaches to better treat patients with metastatic colorectal cancer.”

"This peer-reviewed publication contributes to the growing evidence of the benefit of measuring miR-31-3p in tumors from patients with metastatic colorectal cancer,” said Yann Gaston-Mathé, Director of Molecular Diagnostics at IntegraGen. "This is one more step towards the realization of the benefits of precision medicine as well as generating adoption and coverage for miR-31-3p expression testing.”

IntegraGen has recently announced the CE-IVD Marking and European commercial launch of the company’s miRpredX 31-3p kit, a simple ready-to-use kit designed to quantify the expression of the miR-31-3p in formalin-fixed, paraffin-embedded (FFPE) tumor samples. Earlier this year IntegraGen also announced a licensing agreement with the CERBA laboratories for the development of a laboratory developed test which measures the expression of the miR-31-3p.

About the miRpredX 31-3p Test

The miRpredX 31-3p test is the first positive theranostic test for patients with metastatic colorectal cancer (mCRC). The miRpredX 31-3p test predicts the potential clinical benefits associated with first-line anti-EGFR therapy compared to anti-VEGF therapy or when second or further lines of treatment with anti-EGFR therapy is beneficial versus chemotherapy alone for patients with RAS wild type (WT) mCRC. A recent study demonstrated that expression of the miR-31-3p is a predictive marker of both overall survival and response to treatment with anti-EGFR therapy¹. The study also demonstrated that patients whose expression level is measured below the pre-defined threshold treated with FOLFIRI plus cetuximab have a one year longer median overall survival, a 40% reduction in mortality risk, and a better treatment response compared to patients treated with FOLFIRI plus bevacizumab.

For more information on the miRpredX 31-3p test visit www.miRpredX.com.

About Metastatic Colorectal Cancer

Colorectal cancer is third most common cancer in men and second most common in women with over 1.3 million new cases annually on a worldwide basis. This includes over 345,000 new cases in Europe and 135,000 new cases in the United States on an annual basis². An estimated 25% of patients with colorectal cancer will present with metastatic disease at the time of diagnostic with up to an additional 50% of patients developing mCRC following initial diagnosis³. An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer². Approximately 50% of patients with metastatic colorectal cancer, representing 347,000 patients worldwide, have RAS wild-type tumors⁴.

1. Laurent-Puig P, Grisoni ML, Heinemann V, et al. MiR-31-3p as a predictive biomarker of cetuximab efficacy effect in metastatic colorectal cancer (mCRC) patients enrolled in FIRE-3 study. J Clin Oncol. 2016; 34 (suppl; abstr 3516).

2. World Health Organization – International Agency for Research on Cancer, 2017

3. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D for the ESMO Guidelines Working Group. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014; 25 Suppl 3:iii1-9.

4. Peeters M, et al. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015; 51:1704-13.

About IntegraGen

IntegraGen is a company specializing in deciphering the human genome and producing relevant and easily interpretable data for academic and private laboratories. IntegraGen’s oncology efforts provide researchers and clinicians with sophisticated tools for analysis and therapeutic individualization of treatment approaches allowing them to tailor therapy to the genetic profiles of patients. As of December 31, 2016, IntegraGen had 38 employees and had generated revenue of €6.0 million in 2016. Based in Evry Genopole, IntegraGen also has an U.S. office in Cambridge, Massachusetts. IntegraGen is listed on Euronext Growth (ISIN: FR0010908723 - Ticker: ALINT - PEA-SME).

For more information, visit www.integragen.com

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