EXALT
"Proposal to assess an innovative Immunotherapy, based on a thioredox peptide antigen, in a Phase I Trial for Type-1 Diabetes"
| Coordinatore | INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
Organization address
address: 101 Rue de Tolbiac contact info |
| Nazionalità Coordinatore | France [FR] |
| Totale costo | 8˙639˙831 € |
| EC contributo | 6˙000˙000 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2013-INNOVATION-1 |
| Funding Scheme | CP-FP |
| Anno di inizio | 2014 |
| Periodo (anno-mese-giorno) | 2014-02-01 - 2019-01-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
Organization address
address: 101 Rue de Tolbiac contact info |
FR (PARIS) | coordinator | 556˙641.74 |
| 2 |
IMCYSE SA
Organization address
address: RUE DU COLLEGE 12 contact info |
BE (NAMUR) | participant | 3˙852˙000.26 |
| 3 |
QUEEN MARY UNIVERSITY OF LONDON
Organization address
address: 327 MILE END ROAD contact info |
UK (LONDON) | participant | 504˙892.00 |
| 4 |
HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH
Organization address
address: Ingolstaedter Landstrasse 1 contact info |
DE (MUENCHEN) | participant | 427˙892.50 |
| 5 |
INSERM - TRANSFERT SA
Organization address
address: Rue Watt 7 contact info |
FR (PARIS) | participant | 373˙171.00 |
| 6 |
GlaxoSmithKline Biologicals
Organization address
address: Rue de l'Institut 89 contact info |
BE (Rixensart) | participant | 285˙402.50 |
Mappa
Word cloud
Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.
Obiettivo del progetto (Objective)
'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).'