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"Proposal to assess an innovative Immunotherapy, based on a thioredox peptide antigen, in a Phase I Trial for Type-1 Diabetes"

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)."

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Address
Rue De Tolbiac 101
75654 Paris
France
Activity type
Research Organisations
EU contribution
€ 556 641,74
Administrative Contact
Lyddie Laaland (Mrs.)

Participants (5)

IMCYSE SA
Belgium
EU contribution
€ 3 852 000,26
Address
Avenue De L Hopital 1 Giga B34
4000 Sart Tilman
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jérôme Bollue (Mr.)
GLAXOSMITHKLINE BIOLOGICALS SA

Participation ended

Belgium
EU contribution
€ 285 402,50
Address
Rue De L Institut 89
1330 Rixensart
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Philippe Denoel (Dr.)
HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH
Germany
EU contribution
€ 427 892,50
Address
Ingolstadter Landstrasse 1
85764 Neuherberg
Activity type
Research Organisations
Administrative Contact
Juergen Ertel (Dr.)
QUEEN MARY UNIVERSITY OF LONDON
United Kingdom
EU contribution
€ 504 892
Address
327 Mile End Road
E1 4NS London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Greg Dow (Mr.)
INSERM TRANSFERT SA
France
EU contribution
€ 373 171
Address
Rue Watt 7
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Louis Jammayrac (Mr.)