EXALTProject reference: 602515
Funded under :
"Proposal to assess an innovative Immunotherapy, based on a thioredox peptide antigen, in a Phase I Trial for Type-1 Diabetes"
Total cost:EUR 8 639 831,39
EU contribution:EUR 6 000 000
Call for proposal:FP7-HEALTH-2013-INNOVATION-1See other projects for this call
Funding scheme:CP-FP - Small or medium-scale focused research project
"Type-1 diabetes (T1D) is an autoimmune disease in which pancreatic β-cells are gradually destroyed by autoreactive T-cells recognising autoantigens (Auto-Ag) such as GAD65 and insulin. ImCyse, a small SME, has developed a new technology based on short synthetic peptides flanked with a thioredox motif, which silence the pathogenic immune response against several auto-Ag through activation of one auto-Ag specific cytolytic CD4+ T-cells (cCD4). Preclinical work carried out by ImCyse with such peptides in a specific T1D mouse model showed that insulitis, an absolute condition for the development of T1D, is fully prevented (and/or suppressed) upon either active immunisation or passive transfer of GAD65-specific cCD4+ T cells. This was also observed for the prevention of hyperglycaemia.
The overall objective of the project is to perform a Phase I clinical study in adult T1D patients, using an immunotherapeutic (ITx) preparation based on the ImCyse technology. Primary objectives are to obtain safety data and information on the immune response, in particular the induction of cCD4+ T-cells and autoimmune responses. Clinical responses will also be monitored.
A five-member expert international consortium will conduct: co-ordination, ITx optimisation & GMP process development, manufacturing, toxicity evaluation, regulatory filing, preparation and conduct of the clinical trial and exploitation/dissemination of results.
The expectation is to exploit this antigen-specific immune modulation by immunising T1D patients in order to halt disease progression, and also to validate this new technology that could in the long term be applied to other autoimmune diseases. In addition, this project would benefit: patients (better quality of life), the European economy (decreased cost of the disease), science (mechanistic insight), employment (conduct of further trials in Phase II and III) and the synergistic contribution of different partners (SME/industry/public)."
EU contribution: EUR 556 641,74
RUE DE TOLBIAC 101
EU contribution: EUR 3 852 000,26
RUE DU COLLEGE 12
EU contribution: EUR 285 402,5
Rue de l’Institut
EU contribution: EUR 427 892,5
Ingolstaedter Landstrasse 1
Tel.: +49 89 3187 3022
Fax: +49 89 3187 3866
EU contribution: EUR 504 892
327 MILE END ROAD
E1 4NS LONDON
EU contribution: EUR 373 171
Rue Watt 7