Ventricular tachycardia (VT) is an unpredictable and potentially deadly condition and should be promptly treated with catheter ablation and medication, before irreversible and potentially fatal organ damage follows. Unfortunately, this combination of treatments does not prevent VT reoccurrence in 30-50% of VT patients and while they can undergo multiple invasive ablations, technical difficulties or refusal of the patient can lead to a lack of effective treatment options. A promising novel, non-invasive treatment option for VT is stereotactic arrhythmia radioablation (STAR). Besides being non-invasive, STAR can also be used to reach locations that are inaccessible for catheter ablation, which may potentially improve effectiveness of overall VT treatment. Small scale first in men/early phase trials have been performed for STAR, providing proof-of-concept for clinical safety and efficacy. However, patients with recurrent VT are not a homogenous group and each center deals with different inclusion criteria, imaging and/or target definition. Many questions remain and the available studies lack the power to clinically validate the approach and prepare for late stage phase III trials. The STOPSTORM consortium sets out to consolidate all current and future European efforts to clinically validate STAR treatment by merging all data in a validation cohort study, standardising pre-treatment and follow-up, in order to collect the data sets and statistical power needed to unanimously establish clinical safety, efficacy and benefit for STAR. The STOPSTORM consortium also sets out to refine protocols and guidelines, determine volumes of interest, define and model the optimal target region and target dose, also in relation to surrounding healthy tissues (i.e. organs at risk) and determine which patient population and underlying cardiopathies respond best to STAR. By doing so the STOPSTORM consortium paves the way to consensus and future late stage clinical trials for STAR.

Cancer is rapidly becoming the most frequent cause of death in EU. Though enormously expensive (several billions EUR/year), currently available anti-cancer therapies are major causes of chronic diseases. Adoptive immunotherapy with T cells genetically modified with a tumour-reactive chimeric antigen receptor (CAR) is an innovative therapeutic concept, promising to eradicate cancer without causing secondary chronic diseases. This approach is already at an advanced stage of development in the US, but struggles in the EU, due to a number of constrains that will be specifically tackled by this Project. The ultimate goal of EURE-CART is to bring EU at the forefront CAR T-cell immunotherapy. In this Project, we will extend the applicability of CAR T-cell immunotherapy to incurable tumours that have never been tackled with this approach. The EURE-CART Consortium is composed of 6 academic centres, 2 SMEs and 1 large enterprise from 6 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 starting the conduction of 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 AGC Biologics (formerly Molmed SpA), which 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.

Upper gastrointestinal bleeding (UGIB) is a potentially life-threatening condition that affects approx. 2 million people annually in Europe and in the United States. Current UGIB diagnosis comprises a long and slow set of laboratory tests and culminates ultimately with an endoscopy which is the only conclusive mean for UGIB diagnosis. This results in an over usage of endoscopic resources every time there is a suspicion of a bleed. Clinical data shows that up to 60% of the time endoscopy and consequent hospital admission is not necessary. In addition, endoscopy is invasive, expensive (approx. €2433) and cannot deliver prolonged monitoring. Multi-disciplinary consortium led by EnteraSense are developing a disruptive technology ‘PillSense’ which enables real-time detection of UGIB and subsequent monitoring of high risk patients without the need of endoscopy. The product includes an ingestible capsule and an external receiver. The capsule contains an optical based sensor to detect bleeding in the upper gastrointestinal tract. EnteraSense development team has already proven the core technology through lab-testing and in-vivo clinical studies. During this FTI project, the consortium aims to optimise PillSense product design, gain regulatory approvals, develop a commercial scale manufacturing process and gain clinical approval through two stages in-human clinical trials. Successful development and commercialisation will enable consortium to generate revenues of €59million and a gross profit of €29million over five years- post commercialisation.