Obiettivo 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. Campo scientifico natural sciencesbiological sciencesbiochemistrybiomoleculesagricultural sciencesanimal and dairy sciencedomestic animalsmedical and health sciencesbasic medicineimmunologyautoimmune diseasesmedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccinesmedical and health sciencesbasic medicinetoxicology Programma(i) FP7-HEALTH - Specific Programme "Cooperation": Health Argomento(i) HEALTH.2013.1.3-3 - Safety and efficacy of therapeutic vaccines Invito a presentare proposte FP7-HEALTH-2013-INNOVATION-1 Vedi altri progetti per questo bando Meccanismo di finanziamento CP-FP - Small or medium-scale focused research project Coordinatore INSERM TRANSFERT SA Contributo UE € 355 284,16 Indirizzo 10 RUE D'ORADOUR-SUR-GLANE - PARISANTE CAMPUS 75015 PARIS Francia Mostra sulla mappa Regione Ile-de-France Ile-de-France Paris Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Florence Chung (Ms.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato Partecipanti (5) Classifica in ordine alfabetico Classifica per Contributo UE Espandi tutto Riduci tutto CURAVAC EUROPE SPRL Belgio Contributo UE € 2 101 840,40 Indirizzo AVENUE DE VILLEFRANCHE 80 1330 RIXENSART Mostra sulla mappa Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Nicolas Havelange (Mr.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato PICHEM FORSCHUNGS-UND ENTWICKLUNGSGMBH Austria Contributo UE € 1 162 000,00 Indirizzo PARKRING 3 8074 Raaba-Grambach Mostra sulla mappa Regione Südösterreich Steiermark Graz Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Fritz Andreae (Dr.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato ACADEMISCH ZIEKENHUIS LEIDEN Paesi Bassi Contributo UE € 1 061 595,84 Indirizzo ALBINUSDREEF 2 2333 ZA Leiden Mostra sulla mappa Regione West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Tipo di attività Higher or Secondary Education Establishments Contatto amministrativo Jan Verschuuren (Prof.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato AEPODIA SA Belgio Contributo UE € 779 999,60 Indirizzo RUE LOUIS DE GEER 6 1348 OTTIGNIES LOUVAIN LA NEUVE Mostra sulla mappa Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Charlotte Cuvelier (Mrs.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato UNIVERSITAIR ZIEKENHUIS ANTWERPEN Belgio Contributo UE € 440 000,00 Indirizzo DRIE EIKENSTRAAT 655 2650 Edegem Mostra sulla mappa Regione Vlaams Gewest Prov. Antwerpen Arr. Antwerpen Tipo di attività Research Organisations Contatto amministrativo Daisy Van Mieghem (Ms.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato
