Community Research and Development Information Service - CORDIS

H2020

RABIOPRED Report Summary

Project ID: 666798

Periodic Reporting for period 1 - RABIOPRED (RABIOPRED - Clinical validation of BIOmarker assay to PREDict treatment response in Rheumatoid Arthritis (RA) patients)

Reporting period: 2015-07-01 to 2016-06-30

Summary of the context and overall objectives of the project

"Personalization is the nature’s art and fashion. With the advent of more precision tools, personalized medicine is making its way in the current medical practice, eventually conquering every ailment of human society. With personalized tools, it is now possible to tailor the treatment according to individual response and genotype, hence lowering the costs and avoiding unnecessary side-effects of the treatment. The RABIOPRED project is one of such efforts of Tcland Expression S.A. to develop a non-invasive in vitro companion diagnostic tool that would help clinicians choose a better treatment strategy for patients with active Rheumatoid Arthritis. More specifically, the aim of this project is to take the final steps in order to bring an innovative set of biomarkers that is able to predict response to treatment of TNF-α inhibitors used in the treatment of Rheumatoid Arthritis (RA). Millions of RA patients are treated with TNF-α inhibiting agents, currently one of the main second-line treatment strategies for RA. These expensive biological therapies represent a multibillion market. However, the TNF-α inhibiting agents are not effective in 30-40% of the patients. Clinicians are currently unable to predict the response to this treatment beforehand. The ability to predict response to treatment would greatly improve clinical decision-making, improve health outcomes for RA patients, and contribute to cost reduction and sustainability of the health-care system.

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IMAGE ATTACHED: "RABIOPRED as a biological basis for guiding anti-TNF therapy in RA patients."
(This image is uploaded and available on the section "Images attached to the Summary for publication")

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The RABIOPRED assay is based on a novel gene expression signature and a predictive model that have been identified, developed and patented by Tc Land Expression. Proof-of-concept has already been obtained for the prototype biomarker assay. The analytical validation and clinical performance evaluation of the RABIOPRED assay are the final development steps which are being performed in the current project that would allow towards market introduction and clinical application. At the end of this 3.5 year project, a validated and CE registered IVD biomarker assay will be available that is ready for clinical application, initial market introduction and further commercialization and implementation.

Tc Land Expression is a French SME developing biomarkers for personalized medicine and companion diagnostics in immune mediated disorders. TcLand focusses on development and validation of non-invasive multi-gene molecular diagnostic blood tests. Tc Land is embedded in an international network of collaborating pharmaceutical companies and clinical centers throughout Europe, facilitating clinical performance evaluation and enhancing subsequent market uptake of novel biomarkers assays."

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The RABIOPRED project launched formally on July 1, 2015. The official kickoff meeting with the clinical partners took place on July 7, 2015 at Tcland facility. During this day long meeting, the partners were briefed about the project with details on all work packages and finances. Responsibilities were assigned and tasks were delegated to respective key partners and collaborators. Since the start of this project, we have made significant progress in achieving our targets. Six work packages out of eight are currently active and we have delivered reports on 8 deliverables and achieved 1 milestone so far.

The important steps of clinical qualification of RABIOPRED assay involves analytical and clinical validation of its signature in sufficient number of patients’ samples. For this purpose, our team has successfully designed the analytical validation plan in conformity with the HTG Molecular Diagnostics recommendations. Clinival Investigation Plan along with Clinical protocols for Healthy Volunteer Study and for Proof-of-Performance Study have been written. In order to receive regulatory advice on the analytical validation plan and clinical protocols, we also sought advice from European Medicine Agency (EMA). The clinical study protocols, informed consents and information brochure for patients have been submitted to local ethics committee and ANSM (Agence nationale de securite du medicament et des produits de santé) for authorization. Other supporting documents and Standard Operative Procedures (SOP) for clinical operations are currently under development. As a part of commercialization plan, RABIOPRED project website is active since the beginning of this project. It can be accessed via the following link: http://www.rabiopred-project-h2020.eu. This website is a tool for dissemination of most up-to-date information about the project advancements. Tcland has been also active in presentation of RABIOPRED assay in different workshops and congresses. The team gave a talk at a scientific workshop held in London on 10-12th February 2016. Later in EULAR 2016 conference, Tcland presented a poster on preliminary results obtained on HTG EdgeSeq platform that is being used for RABIOPRED assay. The company also contacted different association of Rheumatology in order to disseminate the information about advancement and the usefulness of the RABIOPRED IVD kit.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The RABIOPRED project has made significant progress in its operations. The project aims at bringing a novel biomarker assay in the form of an in vitro diagnostic kit in the market that will improve treatment decisions and health outcomes for patients of Rheumatoid Arthritis. More specifically, the assay will facilitate prediction of treatment response of TNFα inhibitors prior to starting the treatment, thereby increasing treatment efficiency and reducing health care costs. With the help of this assay, the clinicians will be able to make better treatment decisions. Besides guiding in the right treatment choice, the assay would also help in the stratification of patients for clinical trials in order to improve drug development. Patient identification for a tailored drug is the way forward in the field of personalized medicine.

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