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)    more  Organization address address: 101 Rue de Tolbiac city: PARIS postcode: 75654 contact info Titolo: Mrs. Nome: Lyddie Cognome: Laaland Email: send email Telefono: 33140784935 Fax: 33140784998
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

#	participant	country	role	EC contrib. [€]
1	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)  Organization address address: 101 Rue de Tolbiac city: PARIS postcode: 75654 contact info Titolo: Mrs. Nome: Lyddie Cognome: Laaland Email: send email Telefono: 33140784935 Fax: 33140784998	FR (PARIS)	coordinator	556˙641.74
2	IMCYSE SA  Organization address address: RUE DU COLLEGE 12 city: NAMUR postcode: 5000 contact info Titolo: Mr. Nome: Jérôme Cognome: Bollue Email: send email Telefono: 3226335651 Fax: 3226531438	BE (NAMUR)	participant	3˙852˙000.26
3	QUEEN MARY UNIVERSITY OF LONDON  Organization address address: 327 MILE END ROAD city: LONDON postcode: E1 4NS contact info Titolo: Mr. Nome: Greg Cognome: Dow Email: send email Telefono: 442079000000 Fax: 442079000000	UK (LONDON)	participant	504˙892.00
4	HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH  Organization address address: Ingolstaedter Landstrasse 1 city: MUENCHEN postcode: 85764 contact info Titolo: Dr. Nome: Juergen Cognome: Ertel Email: send email Telefono: +49 89 3187 3022 Fax: +49 89 3187 3866	DE (MUENCHEN)	participant	427˙892.50
5	INSERM - TRANSFERT SA  Organization address address: Rue Watt 7 city: PARIS postcode: 75013 contact info Titolo: Mr. Nome: Louis Cognome: Jammayrac Email: send email Telefono: 33155030100 Fax: 33155030160	FR (PARIS)	participant	373˙171.00
6	GlaxoSmithKline Biologicals  Organization address address: Rue de l'Institut 89 city: Rixensart postcode: 1330 contact info Titolo: Dr. Nome: Philippe Cognome: Denoel Email: send email Telefono: 3226564032	BE (Rixensart)	participant	285˙402.50

Mappa

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 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).'