Objectif The MYASTERIX project will advance a therapeutic vaccine candidate (designated orphan drug) indicated for the autoimmune disease myasthenia gravis (MG) to clinical proof of concept studies. MG is caused by T cell dependent antibodies that bind to and deplete acetylcholine receptors (AChR) at neuromuscular junctions causing muscle weakness by interfering with neuromuscular transmission and junction architecture. The vaccine candidate comprises two synthetic peptides designed to generate antibodies that bind to autoantibodies and T-cell receptors associated with MG. These peptides prevented or improved muscle fatigue in a rat model of MG and increased the remission rate to 75% in pet dogs (compared to 17% natural remission rate in historical controls). In both models, administration of the peptides resulted in reduced titres of anti-AChR antibodies and lower numbers of anti-AChR T-cells, based on the induction of antibodies that bound to the corresponding B and T cell antigen receptors. These results suggest that similar antigen receptor mimetic vaccination approaches could drive autoimmune diseases like MG into long-term remission.The objectives of the project are to manufacture toxicology and clinical batches of the vaccine human formulation based on already developed and tested standard operating procedures, to carry out stability and regulatory toxicity testing of the GMP product, to conduct phase I and subsequently phase II clinical trials to demonstrate safety, tolerability and proof of mechanism of action/concept of the therapeutic vaccine.The impact on MG patients will be to offer a targeted therapeutic approach requiring only three injections, bringing significant and lasting improvement or even a cure. MG is a model for many autoimmune diseases and the concept of targeted therapeutic vaccines could lead to a new class of drugs for the treatment of autoimmune diseases more generally, with a significant impact on innovation, competitiveness and society. Champ scientifique natural sciencesbiological sciencesbiochemistrybiomoleculesagricultural sciencesanimal and dairy sciencedomestic animalsmedical and health sciencesbasic medicineimmunologyautoimmune diseasesmedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccinesmedical and health sciencesbasic medicinetoxicology Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Thème(s) HEALTH.2013.1.3-3 - Safety and efficacy of therapeutic vaccines Appel à propositions FP7-HEALTH-2013-INNOVATION-1 Voir d’autres projets de cet appel Régime de financement CP-FP - Small or medium-scale focused research project Coordinateur INSERM TRANSFERT SA Contribution de l’UE € 355 284,16 Adresse 10 RUE D'ORADOUR-SUR-GLANE - PARISANTE CAMPUS 75015 PARIS France Voir sur la carte Région Ile-de-France Ile-de-France Paris Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Florence Chung (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée Participants (5) Trier par ordre alphabétique Trier par contribution de l’UE Tout développer Tout réduire CURAVAC EUROPE SPRL Belgique Contribution de l’UE € 2 101 840,40 Adresse AVENUE DE VILLEFRANCHE 80 1330 RIXENSART Voir sur la carte Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Nicolas Havelange (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée PICHEM FORSCHUNGS-UND ENTWICKLUNGSGMBH Autriche Contribution de l’UE € 1 162 000,00 Adresse PARKRING 3 8074 Raaba-Grambach Voir sur la carte Région Südösterreich Steiermark Graz Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Fritz Andreae (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée ACADEMISCH ZIEKENHUIS LEIDEN Pays-Bas Contribution de l’UE € 1 061 595,84 Adresse ALBINUSDREEF 2 2333 ZA Leiden Voir sur la carte Région West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Type d’activité Higher or Secondary Education Establishments Contact administratif Jan Verschuuren (Prof.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée AEPODIA SA Belgique Contribution de l’UE € 779 999,60 Adresse RUE LOUIS DE GEER 6 1348 OTTIGNIES LOUVAIN LA NEUVE Voir sur la carte Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Charlotte Cuvelier (Mrs.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée UNIVERSITAIR ZIEKENHUIS ANTWERPEN Belgique Contribution de l’UE € 440 000,00 Adresse DRIE EIKENSTRAAT 655 2650 Edegem Voir sur la carte Région Vlaams Gewest Prov. Antwerpen Arr. Antwerpen Type d’activité Research Organisations Contact administratif Daisy Van Mieghem (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée