EURE-CART: (EURopean Endeavour for Chimeric Antigen Receptor Therapies)
About EURE-CARTCancer is a chronic disease rapidly becoming the most frequent cause of morbidity and mortality in the EU. Though enormously expensive (several billions EUR/year), currently available anti-cancer therapies are highly toxic and often ineffective and are major causes of chronic diseases.
Adoptive immunotherapy with T cells genetically modified to express a tumour-reactive chimeric antigen receptor (CAR) is an innovative therapeutic concept, promising to eradicate cancer once for all, without causing chronic disabilities. The goal of EURE-CART is to bring EU at the forefront CAR-T cell immunotherapy and extending its applicability to incurable tumours that so far have never been tackled with this approach.
EURE-CART project’s main object is to conduct a multicentre, first-in-man Phase I/IIa clinical trial to demonstrate the safety and the efficacy of CD44v6 CAR-T cell immunotherapy in acute myeloid leukaemia and multiple myeloma.
CD44v6 CAR-T, is part of the CAR-T (Chimeric antigen-receptor-engineered T cells) family: lymphocytes armed with chimeric receptors that have demonstrated high anti-tumour potential, also against tumours, which are particularly aggressive and resistant to traditional therapies. CAR-CD44v6, which has already been successfully tested in appropriate murine models, represents a product candidate with a particularly high therapeutic potential, as it specifically recognises variant 6 (v6) of the antigen CD44 (CD44v6), expressed by many haematological malignancies, including acute myeloid leukaemia and multiple myeloma - as well as by several epithelial tumours, including breast, colon, pancreatic, head-and-neck and lung carcinomas.
Context & BackgroundEURE-CART participants believe that patient-derived T cells genetically modified to express a tumour-targeting chimeric antigen receptor (CAR) will contribute to shaping the next generation of personalised cancer therapies. It is therefore anticipated that EURE-CART will have a significant impact on the life and wellbeing of cancer patients, their families and health care providers, as well as on the sustainability and excellence of EU health care systems.
ObjectivesThe main expected impact of EURE-CART is to strengthen the leader role of the EU in translational research, to establish CAR T-cell immunotherapy as the ultimate personalised therapy for cancer and to create secure new jobs in the EU through the instalment of an unprecedented alliance between academia, industry and regulatory bodies.
- To pioneer CAR-T cell immunotherapy in the EU
- To make a harmonised effort on advanced therapies
- To foster the implementation of cellular therapies in the EU
- Promoting personalised cancer therapy for better outcomes and reduced costs
- Leveraging the role of advanced therapies for chronic diseases
- Strengthening the academia-biotech partnership to "make it happen"
- Creating equal opportunities in the European research area
Expected ImpactScientific impact: breakthrough research in cancer immunotherapy. The development of immunotherapy strategies for the treatment of cancer was elected ‘Breakthrough of the Year’ by the prestigious Science magazine in 2013, underlying its appeal as a radically innovative and rapidly developing translational research field
Technological impact: bringing the EU at the forefront of advanced therapies. It is expected that EURE-CART will have a considerable and beneficial technological impact on EU research.
Opportunities for economical growth and new jobs: personalised cellular therapeutics as medicinal products. Considering the impressive potential of CAR-T cell immunotherapy, the biotech and pharmaceutical industry has already placed significant investments on its further development at the major academic centres in the US.
About the consortiumThe EURE-CART Consortium is composed of 6 academic centres, 3 SMEs from 5 EU countries, clearly representing excellences in their respective fields. EURE-CART will bring together clinical experts in oncology, and pioneers and leaders in the field of cell and gene therapy for conducting a first-in-man Phase I/II clinical trial. To be successful, EURE-CART proposes the early involvement of National regulatory authorities for accelerating the approval of CAR T-cell immunotherapy, as well as the centralisation of its production by the Molmed Spa. Molmed Spa is uniquely endowed in the EU with the knowhow and experience necessary to meet this ambitious objective, as demonstrated by its unparalleled track record. The main expected impact of EURE-CART is the establishment of CAR T-cell therapy as the ultimate personalised therapy, capable of defeating chronic diseases, and to create secure new jobs in the EU through the instalment of an unprecedented alliance between academia, industry and regulatory bodies.
To carry out this project and to reach clinical translation, a consortium of nine partners from five different EU countries has been established, including clinical, scientific and industrial groups clearly representing excellences in their fields: MolMed S.p.A. (Italy), Ospedale San Raffaele (Italy), Universitätsklinikum Würzburg (Germany), Ospedale Pediatrico Bambino Gesù (Italy), Fundacio Privada Institut de Recerca de L' Hospital de la Santa Creu i Sant Pau (Spain), Fakultni Nemocnice S Poliklinikou Ostrava Foundation (Czech Republic), Istituto Superiore di Sanità (Italy), Acromion GMBH (Germany), ARTTIC SAS (France).
EURE-CART aims at bringing the European Union at the forefront CAR-T cell immunotherapy
The field of CAR-T cell engineering is rapidly moving forward in a global developmental rush. This is where the European research project EURE-CART sets in.
The main objective of EURE-CART is to conduct a multicentre, first-in-man Phase I/IIa clinical trial to demonstrate the safety and the efficacy of CD44v6 CAR-T cell immunotherapy in acute myeloid leukaemia and multiple myeloma. Crucial activities will include GMP-manufacturing of the cellular product, obtaining regulatory approval, and designing and conducting a multicentre clinical trial under GCP in different EU member countries.
In addition, to prepare to the next wave of CAR-T cell immunotherapies, EURE-CART has designed an ambitious concomitant preclinical program aimed at identifying and validating new target antigens and receptors, integrating concepts of combinatorial targeting, and developing personalised tumour models.
The European Union has awarded EURE-CART with 5 Million Euro within the Horizon 2020 - Research and Innovation Framework Programme, section reserved to the new therapies for chronic diseases (including cancer). To carry out this project and to reach clinical translation, a consortium of nine partners from five different EU countries has been established. The coordinator of the EURE-CART project is MolMed Spa. The project started on January 1st 2017 and will go on until December 2020.