Periodic Reporting for period 3 - RABIOPRED (RABIOPRED - Clinical validation of BIOmarker assay to PREDict treatment response in Rheumatoid Arthritis (RA) patients)
Période du rapport: 2018-01-01 au 2018-12-31
"With the advent of novel precision medicine tools, personalized medicine would occupy growing place in the future medical practice. With personalized tools, it is already possible to tailor the treatment according to individual response and genotype, hence optimizing the costs and avoiding unnecessary adverse effects of the treatment. The RABIOPRED project is one of such efforts of Tcland Expression S.A. to develop a non-invasive in vitro theranostic 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 RA patients’ disease management, and contribute to cost optimization and sustainability of the health-care system.
The RABIOPRED assay is based on a novel mRNA expression signature that have been identified, and predictive models developed and patented by The company. The clinical performance evaluation of the RABIOPRED assay is the final development step which is being performed in the current stage of project that would allow towards market introduction and clinical application.
The company is a French SME developing biomarkers for personalized medicine and companion diagnostics in immune mediated disorders using non-invasive molecular diagnostic tests. Tc Land is embedded in an international network of collaborating pharmaceutical companies and clinical centers of excellence throughout Europe, facilitating clinical performance evaluation and enhancing subsequent market uptake of novel biomarkers assays.
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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 mRNA expression signature that have been identified, and predictive models developed and patented by The company. The clinical performance evaluation of the RABIOPRED assay is the final development step which is being performed in the current stage of project that would allow towards market introduction and clinical application.
The company is a French SME developing biomarkers for personalized medicine and companion diagnostics in immune mediated disorders using non-invasive molecular diagnostic tests. Tc Land is embedded in an international network of collaborating pharmaceutical companies and clinical centers of excellence throughout Europe, facilitating clinical performance evaluation and enhancing subsequent market uptake of novel biomarkers assays.
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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 project launched formally on July 1, 2015. The official kickoff meeting with all partners took place on July 7, 2015 . The consortium has made significant progress during the period of past 30 months by successfully delivering reports on 25 out of total 33 deliverables and achieved 9 out of total 16 milestones.
Amongst the Scientific and Business objectives, we have successfully performed :
• Complete analytical validation of the RABIOPRED panel, including reproducibility, assay performance and accuracy, comparison with other technologies.. An RUO version of the RABIOPRED panel has been fully validated and ready to be marketed worldwide for mRNA targeted profiling services.
• Healthy volunteer reference ranges by utilizing samples from a healthy volunteer chronobiology study and other available patients’ cohorts. Initial performance evaluation in samples from retrospective studies. Ultimate clinical validation of the RABIOPRED assay is still awaited as the Clinical Proof-of-Performance study is in progress.
• After submitted the Briefing document, The team has obtained informal advices from EMA in February 2016. A panel of EMA experts advised on the clinical study protocol as well as on the clinical qualification strategy of the RABIOPRED project.
• While analytical validation is almost completed, CE-marking and IVD registration of the RABIOPRED assay is awaited, which will be executed after the conclusion of the RABIOPRED Proof-of-Performance study.
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 consortium has successfully developed a research-use-only (RUO) RABIOPRED HTG panel which is offered for profiling services starting 1Q 2018.
Amongst the Scientific and Business objectives, we have successfully performed :
• Complete analytical validation of the RABIOPRED panel, including reproducibility, assay performance and accuracy, comparison with other technologies.. An RUO version of the RABIOPRED panel has been fully validated and ready to be marketed worldwide for mRNA targeted profiling services.
• Healthy volunteer reference ranges by utilizing samples from a healthy volunteer chronobiology study and other available patients’ cohorts. Initial performance evaluation in samples from retrospective studies. Ultimate clinical validation of the RABIOPRED assay is still awaited as the Clinical Proof-of-Performance study is in progress.
• After submitted the Briefing document, The team has obtained informal advices from EMA in February 2016. A panel of EMA experts advised on the clinical study protocol as well as on the clinical qualification strategy of the RABIOPRED project.
• While analytical validation is almost completed, CE-marking and IVD registration of the RABIOPRED assay is awaited, which will be executed after the conclusion of the RABIOPRED Proof-of-Performance study.
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 consortium has successfully developed a research-use-only (RUO) RABIOPRED HTG panel which is offered for profiling services starting 1Q 2018.
The RABIOPRED project has made significant progress in its operations. The company has already launched an RUO version of RABIOPRED Assaay. In near future, the Rabiopred assay in the form of an in vitro diagnostic kit in the market will be launched soon. This CE-IVD 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.
The Consortium has generated preliminary results on its 1st generation RABIOPRED Assay. These data will be discussed with the EMA for its clinical qualification and CE-marking. The final product launch is expected in 4Q 2019 and based on the initial sales price and the initial market share, the profit for TcLand with the sales of the RABIOPRED assay is expected to grow from € 2.9 million in 2020 to € 15.0 million in 2024. Return on investment is expected 3-4 years after market introduction.
The Consortium has generated preliminary results on its 1st generation RABIOPRED Assay. These data will be discussed with the EMA for its clinical qualification and CE-marking. The final product launch is expected in 4Q 2019 and based on the initial sales price and the initial market share, the profit for TcLand with the sales of the RABIOPRED assay is expected to grow from € 2.9 million in 2020 to € 15.0 million in 2024. Return on investment is expected 3-4 years after market introduction.