Four times is the charm for Theradiag

This fourth development program has been formed to identify, on a cohort of 100 patients, microRNA signatures which would improve the diagnosis of RA, allow for analysis of disease-activity and severity parameters and provide prognosis information regarding response to treatment. These findings could be the subject of a joint patent application by Theradiag and CNRS.

Theradiag has proven again that it is “not only a pioneer in the development, manufacturing and commercialization of high-quality and innovative IVD (in-vitro diagnostic) products, but is also the only French industrial company developing diagnostics and theranostics tests based on microRNAs,” says Michel Finance, CEO of Theradiag.

Reportedly coined years ago by a diagnostics company called PharmaNetics, the term theranostics defines the development of diagnostic tests that can identify which patients are most suited for a drug, and provide feedback on how well the drug is working.

The demand for theranostics is substantial, and the companies that produce these tests are reporting high-growth revenue rates, according to the R&D research group at Theradiag. These companies tout the main benefits of theranostic products as being that patients get optimal treatment while excessive healthcare expenditures are reduced. These products will become more relevant in the coming years as healthcare resources become even more limited, experts predict.

“There are currently very few tools enabling physicians to adapt RA therapies to each patient and choose one treatment over another,” Gérard Tobelem, Theradiag chairman, stated in a news release. “Identifying prognosis factors for response to treatment would bring a huge benefit to RA patients.”

With this fourth partnership, Theradiag significantly strengthens its positioning in the autoimmune diseases segment, and should offer in the near future a complete diagnostics and theranostics portfolio in RA including disease diagnosis (available FIDIS product range and microRNA test under development); disease monitoring (microRNA test under development); monitoring of biotherapies for the disease (available LISA TRACKER portfolio) and identification of treatment response prognosis factors (microRNA test under development), Finance said.

“Our development and partnering strategy is clear,” Finance says. “We want Theradiag to remain a groundbreaking company leading the field of theranostics for autoimmune diseases, alongside our other microRNA developments in AIDS and cancer. Our goal for 2014 is to strengthen the initiatives launched in 2013, and to build new partnerships which will help us increase our theranostics portfolio and accelerate the sales of our products.”

This specific partnership is about “research on microRNA for rheumatoid arthritis,” Finance explains. “Autoimmune diseases are the historical and core therapeutic field of Theradiag. With this new partnership agreement, Theradiag is significantly strengthening its positioning in the autoimmune diseases segment.”

Theradiag’s three previous agreements with CNRS include: one, to determine HIV/AIDS tropism through a microRNA signature; two, an agreement to determine the tropism of HIV/AIDS through long non-coding RNAs (lncRNAs); and three, to provide support in the CaReNA project (Splicos/Theradiag/CNRS) companion diagnostics tests for Splicos’ anti-HIV therapy, Finance says.

“Any new discovery regarding the microRNA signature in these segments will be submitted for a joint patent by CNRS and Theradiag,” he said. “We also have another microRNA partnership with the Cancer Institute of Montpellier, in oncology (rectal cancer).”

The purpose of Theradiag’s first agreement was to implement two of the four theranostics projects as part of CaReNA, which is a collaborative project between Theradiag, Splicos and CNRS signed in 2013.

These two theranostics projects included: one, a companion diagnostic test to the anti-HIV treatment under development by Splicos (SPL‑464), and two, a predictive and monitoring test of HIV/AIDS.

As part of the agreement, CNRS brought scientific and material support to Theradiag in identifiying microRNA signatures, including technical validations and biological and statistical analysis of the signatures.

The second agreement became an extension to the existing agreement between Prestizia and the CNRS for the identification of HIV/AIDS tropism through microRNAs to a new research program on lncRNAs.

“By strengthening its collaboration with CNRS on microRNAs, and extending it to lncRNAs, Theradiag is now at the forefront of research and development of new diagnostics and monitoring tools for HIV/AIDS,” Odile Prigneau, managing director of Prestizia, stated.

Like microRNAs, lncRNA signatures could be used in the development of new diagnostics or for prognosis and monitoring tools for AIDS, particularly to determine the HIV viral load and tropism (CXCR4 or CCR5), the company states. The purpose of this partnership was to determine the scientific, clinical and industrial value of these new biomarkers, which are still largely unexplored in applied research. Commercialization of the first HIV tropism test developed by Theradiag is planned for 2015.

On June 4, 2013, Theradiag announced it significantly strengthened its activities in microRNA by signing a partnership agreement with the Regional Cancer Institute of Montpellier to develop microRNA-based theranostics tools for the screening and monitoring of colorectal cancer.

The goal of the collaborative R&D program, called miCRA, was to assess the expression and predictive role of microRNA in treatment response to radio/chemotherapies for colorectal cancer.

As part of the project, Theradiag identified relevant biomarkers and developed related theranostic assays, the company stated. In parallel, Theradiag opened its new laboratory dedicated to applied research for the development of microRNA-based assays within the Cap Alpha incubator in Montpellier.

The prevalence of RA in France is stable at around 175,000 cases, based on Datamonitor arthritis statistics, Finance said. In the five major European markets, the prevalence of RA is approximately 1.8 million cases, slightly increasing as the population ages. In the seven major markets, the prevalence of RA cases is 4.9 million, again slightly increasing.

“We are applying our theranostics strategy to other large therapeutic areas, such as cancer with our development program on rectal cancer launched in 2013, and to the monitoring of biotherapies in chronic inflammatory diseases with our complete CE-marked, theranostics range LISA TRACKER,” Finance said. “The potential markets for our theranostics kits are huge as they account for more than $80 million in anti-CCR5 treatments in HIV/AIDS, and represent a $300-million market in autoimmune diseases."