Cel 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. Dziedzina nauki natural sciencesbiological sciencesbiochemistrybiomoleculesagricultural sciencesanimal and dairy sciencedomestic animalsmedical and health sciencesbasic medicineimmunologyautoimmune diseasesmedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccinesmedical and health sciencesbasic medicinetoxicology Program(-y) FP7-HEALTH - Specific Programme "Cooperation": Health Temat(-y) HEALTH.2013.1.3-3 - Safety and efficacy of therapeutic vaccines Zaproszenie do składania wniosków FP7-HEALTH-2013-INNOVATION-1 Zobacz inne projekty w ramach tego zaproszenia System finansowania CP-FP - Small or medium-scale focused research project Koordynator INSERM TRANSFERT SA Wkład UE € 355 284,16 Adres 10 RUE D'ORADOUR-SUR-GLANE - PARISANTE CAMPUS 75015 PARIS Francja Zobacz na mapie Region Ile-de-France Ile-de-France Paris Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Kontakt administracyjny Florence Chung (Ms.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych Uczestnicy (5) Sortuj alfabetycznie Sortuj według wkładu UE Rozwiń wszystko Zwiń wszystko CURAVAC EUROPE SPRL Belgia Wkład UE € 2 101 840,40 Adres AVENUE DE VILLEFRANCHE 80 1330 RIXENSART Zobacz na mapie Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Kontakt administracyjny Nicolas Havelange (Mr.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych PICHEM FORSCHUNGS-UND ENTWICKLUNGSGMBH Austria Wkład UE € 1 162 000,00 Adres PARKRING 3 8074 Raaba-Grambach Zobacz na mapie Region Südösterreich Steiermark Graz Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Kontakt administracyjny Fritz Andreae (Dr.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych ACADEMISCH ZIEKENHUIS LEIDEN Niderlandy Wkład UE € 1 061 595,84 Adres ALBINUSDREEF 2 2333 ZA Leiden Zobacz na mapie Region West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Rodzaj działalności Higher or Secondary Education Establishments Kontakt administracyjny Jan Verschuuren (Prof.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych AEPODIA SA Belgia Wkład UE € 779 999,60 Adres RUE LOUIS DE GEER 6 1348 OTTIGNIES LOUVAIN LA NEUVE Zobacz na mapie Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Kontakt administracyjny Charlotte Cuvelier (Mrs.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych UNIVERSITAIR ZIEKENHUIS ANTWERPEN Belgia Wkład UE € 440 000,00 Adres DRIE EIKENSTRAAT 655 2650 Edegem Zobacz na mapie Region Vlaams Gewest Prov. Antwerpen Arr. Antwerpen Rodzaj działalności Research Organisations Kontakt administracyjny Daisy Van Mieghem (Ms.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych