Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
First in Man Novel Anticancer Therapeutic based on Dependence Receptors Concept (HERMIONE-2MAN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Horizontal topics for collaborative projects relevant for the whole of theme health
Action type: Collaborative project
Countries involved: France,Austria,Belgium
Call:  (FP7-HEALTH-2013-INNOVATION-2, 2013)
Start date: 2013-09-01
End date: 2016-08-31
Duration (months): 36.0
Total project cost (EUR): 7750543.0
EU funding (EUR): 5962231.0
Participants: 4
Project status: CLOSED

It is usually assumed that transmembrane receptors are inactive unless bound by their respective ligand. Against this dogma, the CLB proposed that some receptors may also be active in the absence of ligand and in this case trigger cell death. These receptors were called dependence receptors (DR) as their expression at the cell surface leads the cell to be dependent for its survival on ligand availability. The prototypic DRs are receptors DCC and UNC5H that bind their ligand netrin-1. The FP6 HERMIONE project (2006-2009) aimed to show DRs are negative regulators of tumor progression and to provide a setting in which DRs could be used in therapeutic perspective. The project was successful in these 2 aspects. Of interest, it was shown that in a large fraction of human cancers netrin-1 is autocrinally expressed to block DCC/UNC5H-induced apoptosis and that interference with netrin-1/receptors interaction is associated with tumor growth and metastasis inhibition in animal models of various cancer types. The results of HERMIONE and subsequent R&D performed by the HERMIONE-spin-off company Netris Pharma (NP) allowed the development of a promising anti-cancer drug candidate (anti-netrin mAb). Large pharmaceutical firms declared their interest to acquire this biologic after completion of human safety and possibly efficacy data. The challenge now is to bring rapidly and successfully this product to the patients. This requires maximum effort to develop the anti-netrin mAb production process, to perform preclinical regulatory toxicology and pharmacology, to evaluate the safety and gain some data on the efficacy of this biologic in human. The final objective of the project is a first-in-class first-in-man clinical trial. The HERMIONE-2MAN project will pave the way to an outstanding & innovative approach of cancer treatment, offering great clinical and market potential. The consortium gathers 1 academic partner (CLB), 2 SMEs (NP & Polymun) and a non-profit organization (EORTC).

Keywords: new therapies,preclinical activities,clinical trial,cancer treatment,dependence receptor,first-in-man,first-in-class,netrin-1
Donor T Cells for Immune Control (T-CONTROL)

Framework: FP7 — Cooperation
Programme: Health
Destination: Horizontal topics for collaborative projects relevant for the whole of theme health
Action type: Collaborative project
Countries involved: Germany,United Kingdom,Germany,Netherlands,Germany
Call:  (FP7-HEALTH-2013-INNOVATION-2, 2013)
Start date: 2013-05-01
End date: 2017-01-31
Duration (months): 45.0
Total project cost (EUR): 7437856.0
EU funding (EUR): 5682536.0
Participants: 6
Project status: CLOSED

Patients with high-risk hematological tumors can be cured by allogeneic hematopoietic stem cell transplantation (HSCT). However, the main causes of failure of HSCT are infections, tumor relapse and over-shooting immune responses of the donor T cells to healthy cells and tissues of the patient or graft-versus host disease (GvHD). Therefore, this treatment is still associated with a high morbidity and mortality, as well as a high economic burden. Our previous EU FP6 project, ALLOSTEM, resulted in a number of achievements, including a ‘first in man’ clinical trial that used a highly innovative novel cell selection strategy (Streptamer technology) for the generation of non-ATMP (advanced therapy medicinal product) monovirus specific T cell products. Continuing from ALLOSTEM, we now aim to develop two novel Streptamer-based clinical cell selection processes and its corresponding cell products. A multispecific T cell product targeting several viruses and tumors as well as a primary regulatory T cell product targeting GvHD will be developed to market maturity. These two cell products will improve the outcome of allogeneic HSCT. A significant improvement in the outcome and this coupled with a significant reduction of the costs for a large number of patients in Europe will further broaden the application in other forms of cancer of this curative treatment. In order to achieve this goal we assembled a consortium led by the University Hospital of Würzburg with Prof. Einsele as scientific coordinator together with renowned clinical scientists in the field of HSCT (all key players in ALLOSTEM).

Keywords: allogeneic stem cell transplantation,infection,leukemia,tumor relapse,gvhd,cell therapy,antigen-specific t cells,regulatory t cells,streptamer technology,fp6 project allostem
Oral Vaccination against Clostridium difficile Infection (CDVAX)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: United Kingdom,France,France,Belgium,Germany
Call:  (FP7-HEALTH-2013-INNOVATION-2, 2013)
Start date: 2013-06-01
End date: 2016-11-30
Duration (months): 42.0
Total project cost (EUR): 7570783.6
EU funding (EUR): 5808756.8
Participants: 5
Project status: CLOSED

Clostridium difficile infection (CDI) is a major threat to public health in the industrialised world, particularly in Europe. In many EU countries C. difficile now eclipses Methicillin resistant S. aureus (MRSA) with hospital acquired infection mortality exceeding that of MRSA by a factor of four. C. difficile is resistant to a wide range of antibiotics with hypervirulent and multiple drug resistant strains now emerging. Vaccines are under development, but all are injectable and as such will elicit only a systemic immune response whereas growing scientific evidence suggests that to effectively prevent infection mucosal immunity is critical. Further, full protection to CDI (primary infection and recurrence) requires anti-toxin antibody responses as well as decolonisation of C. difficile spores. Our approach will be to use a novel mucosal vaccine delivery system based on the use of inactivated Bacillus subtilis spores that express two different recombinant C. difficile antigens on their surface, a toxoid antigen and a unique spore colonisation factor. In vivo proof of concept studies has provided compelling evidence for their use in a robust oral vaccine to CDI. This project aims to construct and optimise B. subtilis spores expressing these two antigens and to undertake therapeutic development. Our approach will use inactivated, killed, spores and oral delivery addressing any ethical issues that might arise. A patent application has been filed protecting this unique oral spore vaccine approach. A consortium has been built of SMEs with the expertise to optimise the therapeutic product and address its safety and immunogenicity in both preclinical and phase I clinical studies. The project will enable a unique oral vaccine against C. difficile to be clinically validated. The expected outcome will be the implementation of this vaccine in further clinical trials as well as validation of a novel vaccine platform that is applicable to other bacterial and viral infections.

Keywords: clostridium difficile,clostridium difficile infection,nosocomial infection drug resistance,multiple drug resistance,hypervirulent strains mucosal,oral,vaccine phase 1 clinical trial
Macroencapsulated Porcine Pancreatic Islets to cure Diabetes Mellitus type 1/2 (XENOISLET)

Framework: FP7 — Cooperation
Programme: Health
Destination: Horizontal topics for collaborative projects relevant for the whole of theme health
Action type: Collaborative project
Countries involved: Belgium,United Kingdom,Italy,Hungary,Hungary
Call:  (FP7-HEALTH-2013-INNOVATION-2, 2013)
Start date: 2013-09-01
End date: 2017-08-31
Duration (months): 48.0
Total project cost (EUR): 6396946.52
EU funding (EUR): 5037148.0
Participants: 5
Project status: CLOSED

During the last five years, within the EU FP6 Integrated Project XENOME (LSHB-CT-2006-037377), we have convincingly demonstrated in primates that a complete control of induced type 1 diabetes is routinely obtained for 6/8 months after transplantation of subcutaneous alginate macroencapsulated porcine islets xenograft without the use of any immunosuppression. In order to improve the function of pig islets, we have produced with AVANTEA a transgenic pig expressing GLP-1 at the level of the pig islets. In fact, GLP1 is not only able to (i) increase the insulin gene expression and insulin biosynthesis, but also to (ii) induce the replication of islet cells and promotes islet-cell neogenesis and (iii) protect islets cells from apoptosis. GLP-1 has already demonstrated its in vivo potential to improve insulin secretion in subjects with impaired glucose tolerance and type 2 diabetes. New vectors (GLP1/M3Rr) containing both GLP1 sequence and muscarinic receptor mutation (M3R) will also be tested. The main objectives of this four-year project will therefore be (1) to evaluate in vitro the effect of GLP1/M3R transgene expression in pig islets after hyperglycaemic challenge; (2) to continue to produce double transgenic pigs specifically expressing GLP-1/M3R in pig islets under insulin promoter, and (3) finally to test these modified pig islets in our well characterized pig-to-diabetic primates model in vivo. However, in order to use islets from newborn unmodified or transgenic pigs, we will also set up (4) the pig islets isolation and cell maturation technique for Neonates Pancreatic Pig Cluster cells since neonates pig islets have prolonged survival and would also render possible the use of Designed Pathogen Free (DPF) neonates pigs which will represent a key point to reach clinical studies. BIOT will be mainly involved in this part of the work which is in vitro purification, amplification of NPCCS. GCU and AVIDIN Ltd will together develop arrays and a set of molecular testing for pig cell pathogens.A pilot study for safety will be achieved whether all the prerequisite are achieved at the end of the fourth year project.

Keywords: diabetes / islet xenotransplantation / alginate macroencapsulation / cell therapy / tissue engineering / regenerative medicine / medical technology / biodevices
Point-of-care tests to revolutionise the clinical management of patients infected by Hepatitis C virus (POC-HCV)

Framework: FP7 — Cooperation
Programme: Health
Destination: Horizontal topics for collaborative projects relevant for the whole of theme health
Action type: Collaborative project
Countries involved: France,Sweden,United Kingdom,Portugal
Call:  (FP7-HEALTH-2013-INNOVATION-2, 2013)
Start date: 2013-09-01
End date: 2016-08-31
Duration (months): 36.0
Total project cost (EUR): 8034430.0
EU funding (EUR): 5991426.0
Participants: 5
Project status: CLOSED

Point-of-care (PoC) medical devices have the potential to revolutionise clinical practice. SMEs within our Consortium (Epistem & Biosurfit) have developed genetic and protein PoC devices to deliver on this promise. Results from these enabling technologies will be integrated using novel bioinformatics tools and algorithms (Qlucore) allowing for bed-side analysis. This integrated genetic-protein approach will exploit recent biomarker discoveries from the FP7 project SPHINX, to improve the management of hepatitis C virus (HCV) infected patients. We will focus on two public health problems: (i) addressing the need to predict, pre-treatment, individuals in resource poor countries (e.g. Egypt) who will benefit from conventional treatment; and (ii) helping to limit treatment costs globally, where new therapies for HCV are anticipated to significantly increase health care expenditures. The predicitve biomarkers are ready for immediate implementation and will greatly improve HCV patient management issues such as decision to treat, selection of therapy, and response-guided monitoring. The predictive power of the SPHINX biomarkers are reliant upon the combination of genetic and protein data. Highlighting the innovative aspect of our proposed work, no clinical algorithms have taken advantage of such a combined genetic / protein biomarker approach for diagnostic tests. To realise this vision, Qlucore will establish patient population-based algorithms that integrate the PoC data on a mobile application, thus facilitating immediate interpretation by physicians. Together, our Consortium will boost prior FP7 discoveries and deliver an integrated platform for predictive and prognostic applications. The associated SMEs will expand their portfolio, but more importantly, our consortium will forge a lasting partnership, formalised by the creation of a new corporation that will have the freedom to market and exploit our collective results.

Keywords: point of care assays,predictive biomarkers,diagnostics / theragnostics,mobile application algorithms,hepatitis c
Evaluation of phage therapy for the treatment of Escherichia coli and Pseudomonas aeruginosa burn wound infections (Phase I-II clinical trial) (PHAGOBURN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: France,France,France,Belgium,Switzerland
Call:  (FP7-HEALTH-2013-INNOVATION-2, 2013)
Start date: 2013-06-01
End date: 2017-02-28
Duration (months): 45.0
Total project cost (EUR): 4920435.99
EU funding (EUR): 3838422.0
Participants: 5
Project status: CLOSED

Sepsis is the major problem of large burn patients and a predominant cause of death. The burn wound pathology, combined to a global intensive use of antibiotics (ATB), put patients at high risk of suffering from multidrug resistant (MDR) infections, notably carried out by the Gram-negative bacteria species: Pseudomonas aeruginosa or Escherichia coli. But the last Gram- ATB is more than 20 years old and impeded by spread out exponential resistance. New ATB with genuine mode of action to target current resistant types are out of scope. In this context, MDR Gram- infections are becoming orphan pathologies without treatment. Fighting MDR in burn trauma is becoming an urgent medical need through innovation. PHAGOBURN is focused on a highly promising alternative to ATB: phage therapy. Bacteriophages are viruses that specifically infect and kill bacteria during their replicative cycle. The main objective of the project is to assess the safety, effectiveness and pharmacodynamics of two therapeutic phage cocktails to treat either E. coli or P. aeruginosa burn wound infections. To reach that goal, a combined Phase I/II multicentric clinical trial will be carried out in 3 EU countries (France, Belgium, Switzerland), by different hospital burn units. Prior to that, a GMP bioproduction process will be implemented to produce both drug products according to current EMA standards. Meanwhile, the production process and the trial results will provide basis for an optimization of current regulatory guidelines. PHAGOBURN is coordinated by the French Ministry of Defence. The Consortium also includes the following partners: Pherecydes (French SME) and Clean Cells (French SME) for the GMP bioproduction of drug products, CHU Vaudois (CH) burn wards, as well as the Royal Military Academy of Belgium (Queen Astrid).

Keywords: therapeutic bacteriophages,phage therapy,bacterial infections,multidrug resistant bacteria,burn wounds,clinical study,phase i,phase ii
Mutanome Engineered RNA Immuno-Therapy (MERIT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Horizontal topics for collaborative projects relevant for the whole of theme health
Action type: Collaborative project
Countries involved: Germany,France,Belgium,Switzerland,Sweden
Call:  (FP7-HEALTH-2013-INNOVATION-2, 2013)
Start date: 2013-06-01
End date: 2017-11-30
Duration (months): 54.0
Total project cost (EUR): 7794995.47
EU funding (EUR): 5964250.0
Participants: 5
Project status: CLOSED

The Mutanome Engineered RNA Immuno-Therapy (MERIT) project aims to clinically translate and industrially validate a pioneering RNA-based immunotherapy approach to target the individual tumour antigen signature. MERIT focuses on previous inventions, fits into the overall business and innovation needs of the partners, and addresses triple-negative breast cancer patients with high medical need. The MERIT concept, including patents and potential products, was developed using EU FP6 funding. The innovative therapeutics will pave the way for generation of scientific knowledge and technologies and will stimulate the development of new products, tools, patents, and innovative marketable applications. The concept behind MERIT is to implement a highly innovative Next-Generation-Immunotherapy drug platform enabling Next–Generation-Sequencing-guided stratified medicine and clinical-grade individualized RNA vaccines. Every patient’s tumour expresses many shared tumour-specific antigens and bears a highly individual molecular “signature” comprising 10’s to 100’s of non-synonymous mutations, many of which are immunogenic. We will use clinical-grade RNA to produce a) a warehouse of therapeutic vaccines targeting shared antigens and b) custom therapeutic vaccines targeting patient-specific mutations. Upon success, partner BioNTech will move the therapeutics to advanced clinical trials and commercial applications for the benefit of triple negative breast cancer patients and other solid tumours.

Keywords: rna vaccine,cancer genomics,new gene-,immunotherapy,individualized/personalized medicine,triple-negative breast cancer,clinical trial,gmp manufacturing,liposomal drugs,biomarker,immunomonitoring
Two-phase Acid/Gas Anaerobic Reactor for Industrial Wastewater of Food & Drink SME industries (PHASEPLIT)

Framework: FP7 — Capacities
Programme: Research for the benefit of SMEs
Destination: Research for SMEs
Action type: Research for the benefit of specific groups
Countries involved: France,France,Spain,Portugal,Spain,Romania
Call:  (FP7-SME-2013, 2013)
Start date: 2014-09-01
End date: 2016-11-30
Duration (months): 27.0
Total project cost (EUR): 1481154.79
EU funding (EUR): 1124000.0
Participants: 8
Project status: CLOSED

More than 99% of European Food & Drink companies are small and medium enterprises. Industrial food production generates a lot of polluting wastewater. the Urban Waste Water Directive has set strict regulations to the quality of waste water discharged from these industries to the environment. But treating wastewater is expensive. The smaller the company is, the more expensive it is to treat 1m3 of wastewater. Anaerobic treatment is an eco-efficient solution: biogas can be transformed at the Food & Drink industries in electricity and heat. Current anaerobic reactors available in the market are good but they are extremely expensive for SMEs. PhasepliT is an SME-size anaerobic wastewater reactor achieving a reduction of capital investment costs by 50% and operational costs by 30% to generate enough renewable energy from biogas to cover the reactor’s consumption and generate a surplus for the SME. Phaseplit will separate the anaerobic treatment in two-phases: acidogenic and metanogenic. 100% of current wastewater anaerobic alternatives are single-phase. This is the first time two-phase acid/gas separation will be used for wastewater treatment. We have estimated a 1.5% penetration (4,500 reactors) in the 99% SME-based Food and Drink sector by our decentralised two-phase anaerobic wastewater reactor. The potential economic impact of PhasepliT is estimated to be EUR 823 million in five years post project and after a time to market of 24 months. PhasepliT will also have a potential application in spill-over markets (chemical, pharmaceutical, textile). PhasepliT is expected to have the very significant contribution to European Objectives of EUR 329 million, by reducing organic pollution in fresh waters and contributing to the 20% of renewable energy in 2020 European objective.

Keywords: anaerobic,two phase acid/gas,acidogenic,methanogenic,wastewater treatment,phase separation,fuzzy logic control,eco-efficient design,internal circulation,gas lift reactor
Targeting and exploiting B cell functions for treatment in cardiovascular disease (ATHERO-B-CELL)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: United Kingdom,Denmark,Switzerland,Italy,Sweden,Netherlands,Sweden,United Kingdom,France,Italy
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-09-01
End date: 2018-08-31
Duration (months): 60.0
Total project cost (EUR): 7739594.0
EU funding (EUR): 5892178.0
Participants: 11
Project status: CLOSED

Cardiovascular disease (CVD) mortality and morbidity is predicted to increase in Europe and worldwide in the next decades due to aging and the rise of diabetes and obesity. The link between metabolic and inflammatory disease is getting stronger, raising hopes for novel therapeutic targets to be exploited clinically. Clinical evidence generated by the Academic partners of the Athero-B-Cell Consortium demonstrates that CVD is associated with pro- and anti-atherogenic B cell responses. We aim to use existing proteomic, transcriptomic and miRNA data generated from large-scale clinical studies in previous EU-funded collaborative efforts to decipher the pathways that favor pro- and anti-atherogenic B cell functions in order to unravel a new set of therapeutic targets and refine potential vaccine strategies for CVD. The selection and validation of targets will be made possible by substantial technological advance achieved by the participating SMEs that are world leaders in the field of bioinformatics, genetic modification including humanised mouse models, and 3rd generation antisense drugs with locked nucleic-acid (LNA) design that are in Phase II human trials. Academia-led innovation includes high-resolution methodologies such as CyTOF and ImageStream to interrogate available samples from clinical trials and the ability to validate the targets of interest in accredited models of CVD. The validation in vivo and in vitro of such targets will feed into the SME pipeline accelerating the process of drug discovery. The recent clinical success of 3rd generation antisense drugs underscores the advantage of the Athero-B-Cell approach: the seamless transition from validation tools to clinical applications. Harnessing protective or abating unwanted B cell responses has the potential to improve health, innovation and competitiveness of European SME and Academia, while shedding light on the pathogenesis of CVD, the world's biggest killer.

Keywords: atherosclerosis,b cells,immunity,inflammation,rna interference,cardiovascular disease,oligonucleotides,immune regulation