THERADIAG: Creation of an Experts Committee for the miCRA Project

Regulatory News:

THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER, PEA-PME eligible), a company specializing in theranostics and in vitro diagnostics, announces the creation of an experts committee for its miCRA project to support it with the development of its microRNA theranostics kit for rectal cancer. The miCRA project has received a start-up phase award by the French government’s Worldwide Innovation Challenge.

For the first time, Theradiag has gathered a cross-disciplinary expert committee (clinical oncologists, gastroenterologists, surgeons, anatomical pathologist), all of whom are well-known specialists in treating rectal cancer. This panel will play a consultative role and be involved in continuing the study to identify circulating microRNA biomarkers for the development of a theranostics kit to predict the response to neoadjuvant therapy and metastatic relapse in locally advanced rectal cancer. Alongside clinical observations, this rapid and innovative test will provide a decision-making tool guiding the choice of therapeutic approach at an early stage on a personalized basis before any therapy.

"The creation of this committee of rectal cancer experts will help us to set in motion the biological validation phases for the biomarkers identified recently and patented at the initial stages of the miCRA project. Since it will provide access to retrospective and prospective cohort studies, this committee will help us to accelerate the validation of the microRNAs used to predict patient response to radiochemotherapy and metastatic relapse. This scientific and clinical support will also guide our efforts to confirm the positioning of our future product”, comments Odile Prigneau, General Manager of Prestizia.

"This committee will advise the company and provide its medical expertise, which is critical for the validation of the miCRA project”, adds Michel Finance, Chief Executive Officer of Theradiag. "In view of its frequency (fifth most common form of cancer in France) and its severity given its high rate of metastatic relapse, rectal cancer represents a major public health issue. Identifying predictive biomarkers would represent a valuable tool for selecting the most appropriate therapeutic strategy for each patient”.

About Theradiag’s Expert Committee for the miCRA project:
This Scientific Committee will advise the company on the development of a microRNA theranostics kit for rectal cancer. Its members are:

Professor Eric Assenat, MD-PhD, gastroenterologist and digestive oncologist at the Saint Eloi CHU university hospital in Montpellier, is responsible for treating patients with digestive cancer in the oncology department of medicine of the Montpellier CHU university hospital. He also is lead investigator and joint lead investigator in several clinical trials related to digestive cancer.

Dr Valérie Boige, MD-PhD, a cancer treatment center specialist responsible for treating patients with digestive cancer at the medical oncology department of the Institut Gustave Roussy hospital. She is lead investigator and joint lead investigator in several clinical trials related to digestive cancer and in particular cancer of the rectum (joint lead investigator of the Prodige 23 nationwide clinical trial).

Dr Evelyne Crapez, PhD, Pharm.D, is head of the Translational Research Unit at the Montpellier/Val d’Aurelle Regional Cancer Institute. She works on translational research projects aiming to discover biomarkers for personalized oncology treatments with a focus on digestive cancers.

Dr Astrid Lièvre, MD, is a digestive oncologist at the Curie Institute and the René Huguenin hospital and also Lecturer at the University of Versailles Saint-Quentin in the Yvelines department. For several years, she has pursued an interest in research areas around the molecular markers playing a role in colorectal carcinogenesis representing prognostic and predictive factors of patient response to colorectal cancer therapies.

Professor Frédérique Peschaud, MD-PhD, is Professor of digestive surgery and oncology at Ambroise Paré hospital in Boulogne Billancourt and joint head of department at the University of Versailles Saint-Quentin in the Yvelines department. Her primary research focus is on rectal cancer. She also belongs to the SFCD’s (French digestive surgery society) scientific committee, the "French group” and the AFC.

Dr Anne Rullier, MD-PhD, works in the Pathology department of the Bordeaux CHU university hospital. She is a coordinating anatomical pathologist for national colorectal pathology projects and the pathologist responsible for the French Rectal Cancer Recommendations.

About rectal cancer
Rectal cancer is the fifth most common cancer in France. Currently, more than 17,000 cases of rectal cancer are diagnosed each year in this country, and 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, Germany), the United States and, more recently, Japan. Indeed, on these 7 major markets, 182,000 new cases of rectal cancer were diagnosed in 2010, 40,000 of them in the United States. Taking into account every stage of the illness, the 5-year survival rate for patients suffering from rectal cancer is approximately 65% (sources: Guide infection de longue durée: Cancer colorectal adénocarcinome, INCa/HAS, 2012 and DataMonitor).

About the miCRA project
In 2013, Theradiag put in place a collaborative research and development program in the field of rectal cancer with the Cancer Institute of Montpellier (ICM) called "miCRA” (circulating microRNAs in locally advanced rectal cancer). The miCRA project was one of the 110 projects to receive a start-up phase award by the French government’s Worldwide Innovation Challenge, which is based on the 7 goals defined by the Innovation 2030 Commission chaired by Mrs Anne Lauvergeon. It receives financing from BpiFrance. The aim of this project is to develop a simple, reliable, fast and non-invasive theranostics solution based on a microRNA signature in patients. The test will allow the early prediction of the response prior to any chemo/radiotherapy and anticipation of metastatic recurrences in rectal cancer.

About Prestizia
Prestizia SAS is a biotechnology company founded in 2011. A wholly-owned subsidiary of Theradiag since 2012, it has developed technology and expertise in the identification of the non-coding RNAs known as microRNAs in the blood samples taken from patients. Detected using molecular biology techniques, these microRNAs are used as specific biomarkers. They can be used to identify, provide the best possible therapeutic care or monitor patients with various pathologies such as cancer, HIV, obesity or autoimmune conditions. Prestizia’s ultimate goal is to develop diagnostics and in vitro theranostics kits to be marketed and distributed by its parent company Theradiag.

About Theradiag
Capitalizing on its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag notably markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter theranostics solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is developing new biomarkers based on microRNAs for the diagnosis and monitoring of HIV/AIDS and rectal cancer. Theradiag is thus participating in the development of "customized treatment”, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 65 employees.

For further information about Theradiag, please visit our website: www.theradiag.com