CROISSY-BEAUBOURG, France— In 2013, Theradiag, a French company specializing in theranostics and in-vitro diagnostics, launched a collaborative research and development program in rectal cancer with the Cancer Institute of Montpellier (Institut de Recherche en Cancérologie de Montpellier, or IRCM) called miCRA (for circulating microRNAs in locally advanced rectal cancer). Theranostics is the development of molecular diagnostic tests in tandem with targeted therapeutics.
Now the two entities have announced the launch of the second phase of their study to identify microRNA biomarkers to predict the response to treatment and metastatic relapse in rectal cancer. Biological validation will be carried out on a broader range of patients, in partnership with the IRCM.
More than 17,000 cases of rectal cancer are diagnosed in France every year, making it the fifth most common cancer in that country. This figure is expected to rise to 45,000 new cases annually by 2020. Rectal cancer is also prevalent in Western Europe (United Kingdom, Italy, Spain and Germany), the United States and, more recently, Japan, accounting for 182,000 new cases per year. The five-year survival rate for patients suffering from rectal cancer is approximately 65 percent.
The miRCA project is designed to develop a simple, reliable, fast and non-invasive theranostics solution based on a microRNA signature in patients. The test will enable the early prediction of the response prior to any chemo/radiotherapy and anticipation of metastatic recurrences in rectal cancer. According to Michel Finance, CEO of Theradiag, the objective of the project is to define and patent a signature of miRNA which would predict resurgence (metastatic relapse) of rectal cancer and would predict responses to the treatment (association of chemotherapy and radiotherapy).
The first phase of the miCRA project began at the end of 2013 with the screening of potential microRNA candidates, which was followed by a technical validation on an initial cohort of 70. A biostatistical analysis of the data has helped identify modulated and specific microRNA candidates that predict the response to chemo/radiotherapy treatments and metastatic recurrence in rectal cancer.
The aim of the second phase of this study will be to validate, across a broader range of patients, the biological relevance of the identified microRNA candidates in order to establish a robust signature that could be routinely used in a new theranostics test. This second phase is also being carried out in partnership with the IRCM.
“In the partnership IRCM brings cohorts or samples and expertise in rectal cancer,” explained Finance. “Theradiag brings expertise in miRNA and molecular biology diagnostics.”
He added, “Thanks to our partnership [with IRCM] and to our platform specializing in development applied to microRNAs, we are able to position ourselves on the very large oncology market, on top of our presence on the autoimmune disease market. For the rectal cancer segment, a theranostics kit’s potential world market is estimated at several tens of millions of euros.”
The time frame for completing the project has not been disclosed.
In developing theranostic tests that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS, Theradiag is participating in the development of “customized treatment” that favors the individualization of treatments, the evaluation of their efficiency and the prevention of drug resistance. Theradiag markets the Lisa-Tracker range (CE marked), a comprehensive multiparameter diagnosis solution for patients with autoimmune diseases treated with biotherapies. Theradiag is also developing new diagnostic markers thanks to its microRNA platform, which will allow specific biomarkers to be identified in order to guide therapy and will be first and foremost applied to the treatment of AIDS.
Created in 1923, the IRCM is now recognized as one of the leading national centers for cancer patient care, as well as the benchmark regional center for cancer patients in the Languedoc Roussillon area. There are more than 40,000 consultations and 26,000 patients treated per year. The IRCM is one of the 18 cancer centers, known as CLCCs, of the oncology-focused hospital group called UNICANCER. The IRCM is one of eight research centers in France to have received the Integrated Research Center of Cancer mark, as well as one of France’s leading CLCCs in terms of clinical, fundamental and translational research.
The miCRA project was one of the 110 projects to receive a startup phase award by the French government’s Worldwide Innovation Challenge, which is based on the seven goals defined by the Innovation 2030 Commission. In March, 58 projects out of more than 600 applicants received awards. Winners were announced by the Prime Minister of France and will receive R&D grants from the French Public Investment Bank to finance the startup phase of their project.