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Translational approaches to disease modifying therapy of type 1 diabetes - HARVESTing the fruits of INNODIA

Objective

Building on the strong foundations of INNODIA, with its unique, Europe-wide clinical and basic research network for the study of type 1 diabetes (T1D), we propose in INNODIA HARVEST an ambitious program which aims to prevent and arrest T1D via focused objectives targeting consolidation and innovation. First, we will consolidate the INNODIA clinical network as the reference point for conducting studies to prevent or arrest T1D. We will transform our standardized clinical and bioresource platforms into a high-performance clinical trial network, running academic and industry-driven trials alongside small, mechanism-centric, biomarker-rich intervention trials to examine pathobiological pathways to T1D. INNODIA HARVEST will conduct two large studies to arrest T1D at its onset, one academia-driven, beta-cell focused (VER-A-T1D, verapamil) and one industry-driven, immune-focused (Iscalimab-study). We will exploit our original INNODIA Master Protocol allowing novel adaptive trial design to introduce combination therapies that build on complementary mechanisms. Second, we will extend our study design strategy by introducing novel biomarkers, both clinical (continuous glucose monitoring) and experimental (microbiome analysis) to deconvolute disease heterogeneity and identify new endpoints to accelerate identification of effective therapeutics. Third, we will use ‘disruptors’ in small mechanistic studies to channel innovation from clinic to basic research through a reverse immunology and reverse beta-cell biology approach. Finally, we will implement new discovery pipelines for future therapeutics, exploiting tools such as iPSC-derived islet-like cells to promote next generation target identification and drug development. As in INNODIA, the voice of people living with T1D and their families will hold a central place in INNODIA HARVEST to drive implementation of new, patient-proximal outcomes, shape our clinical trials, and bring about a meaningful change in disease perspective.
A major objective of INNODIA Harvest is the execution of at least two new phase 2 trials (studying Verapamil (VER-A-T1D) or Iscalimab (CCFZ533X2207)). Considering the expected time to first patient-in as preparations for trial start can only be initiated after the start of the Action and possible fluctuating recruiting rates, due to the intercurrent COVID epidemic, there is a risk that INNODIA HARVEST will not be able to completely finalize the clinical trials, fully analyse the biomarkers collected and publish the results in the initially proposed 24 months duration. To ensure the finalization of the clinical trials and corresponding full execution of the given budget including eligibility of EFPIA in-kind contribution we propose to extend the duration of the Action from 24 to 36 months.

Call for proposal

H2020-JTI-IMI2-2019-19-single-stage
See other projects for this call

Funding Scheme

IMI2-RIA - Research and Innovation action

Coordinator

KATHOLIEKE UNIVERSITEIT LEUVEN
Address
Oude Markt 13
3000 Leuven
Belgium
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 682 700

Participants (39)

THE CHANCELLOR MASTERS AND SCHOLARSOF THE UNIVERSITY OF CAMBRIDGE
United Kingdom
EU contribution
€ 427 500
Address
Trinity Lane The Old Schools
CB2 1TN Cambridge
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE UNIVERSITAT GRAZ
Austria
EU contribution
€ 740 570
Address
Auenbruggerplatz 2
8036 Graz
Activity type
Higher or Secondary Education Establishments
UNIVERSITE LIBRE DE BRUXELLES
Belgium
EU contribution
€ 636 875
Address
Avenue Franklin Roosevelt 50
1050 Bruxelles
Activity type
Higher or Secondary Education Establishments
KOBENHAVNS UNIVERSITET
Denmark
EU contribution
€ 155 950
Address
Norregade 10
1165 Kobenhavn
Activity type
Higher or Secondary Education Establishments
REGION HOVEDSTADEN
Denmark
EU contribution
€ 127 500
Address
Kongens Vaenge 2
3400 Hillerod
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 302 500
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
HELSINGIN YLIOPISTO
Finland
EU contribution
€ 425 310
Address
Yliopistonkatu 3
00014 Helsingin Yliopisto
Activity type
Higher or Secondary Education Establishments
OULUN YLIOPISTO
Finland
EU contribution
€ 63 750
Address
Pentti Kaiteran Katu 1
90014 Oulu
Activity type
Higher or Secondary Education Establishments
TURUN YLIOPISTO
Finland
EU contribution
€ 277 500
Address
Yliopistonmaki
20014 Turku
Activity type
Higher or Secondary Education Establishments
HANNOVERSCHE KINDERHEILANSTALT
Germany
EU contribution
€ 186 000
Address
Janusz Korczak Allee 12
30173 Hannover
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH
Germany
EU contribution
€ 51 250
Address
Ingolstadter Landstrasse 1
85764 Neuherberg
Activity type
Research Organisations
TECHNISCHE UNIVERSITAET DRESDEN
Germany
EU contribution
€ 253 750
Address
Helmholtzstrasse 10
01069 Dresden
Activity type
Higher or Secondary Education Establishments
UNIVERSITAET ULM
Germany
EU contribution
€ 38 750
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DEGLI STUDI DI SIENA
Italy
EU contribution
€ 188 750
Address
Via Banchi Di Sotto 55
53100 Siena
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DEGLI STUDI GABRIELE D'ANNUNZIO DI CHIETI-PESCARA
Italy
EU contribution
€ 0
Address
Via Dei Vestini 31
66013 Chieti
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DI PISA
Italy
EU contribution
€ 126 250
Address
Lungarno Pacinotti 43/44
56126 Pisa
Activity type
Higher or Secondary Education Establishments
CENTRE HOSPITALIER DE LUXEMBOURG
Luxembourg
EU contribution
€ 138 750
Address
Rue Nicolas Ernest Barble 4
1210 Luxembourg
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
THE UNIVERSITY OF EXETER
United Kingdom
EU contribution
€ 63 750
Address
The Queen's Drive Northcote House
EX4 4QJ Exeter
Activity type
Higher or Secondary Education Establishments
SLASKI UNIWERSYTET MEDYCZNY W KATOWICACH
Poland
EU contribution
€ 63 750
Address
Ul. Poniatowskiego 15
40 055 Katowice
Activity type
Higher or Secondary Education Establishments
UNIVERZA V LJUBLJANI
Slovenia
EU contribution
€ 76 250
Address
Kongresni Trg 12
1000 Ljubljana
Activity type
Higher or Secondary Education Establishments
UNIVERSITE DE LAUSANNE
Switzerland
EU contribution
€ 0
Address
Quartier Unil-centre Bâtiment Unicentre
1015 Lausanne
Activity type
Higher or Secondary Education Establishments
STICHTING KATHOLIEKE UNIVERSITEIT
Netherlands
EU contribution
€ 71 650
Address
Geert Grooteplein Noord 9
6525 EZ Nijmegen
Activity type
Higher or Secondary Education Establishments
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 252 500
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
KING'S COLLEGE LONDON
United Kingdom
EU contribution
€ 238 750
Address
Strand
WC2R 2LS London
Activity type
Higher or Secondary Education Establishments
LUNDS UNIVERSITET
Sweden
EU contribution
€ 63 750
Address
Paradisgatan 5C
22100 Lund
Activity type
Higher or Secondary Education Establishments
UNIVERCELL BIOSOLUTIONS SAS
France
EU contribution
€ 38 750
Address
Place Pierre Potier Centre Pierre Potier Canceropole Entree B
31000 Toulouse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SANOFI-AVENTIS DEUTSCHLAND GMBH
Germany
EU contribution
€ 0
Address
Bruningstrasse 50
65929 Frankfurt Am Main
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
NOVO NORDISK A/S
Denmark
EU contribution
€ 0
Address
Novo Alle 1
2880 Bagsvaerd
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
EU contribution
€ 0
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Eli Lilly and Company Limited
United Kingdom
EU contribution
€ 0
Address
Lilly House, Priestley Road
RG24 9NL Basingstoke
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
JDRF INTERNATIONAL
United States
EU contribution
€ 0
Address
26 Broadway 14Th Floor
10004 New York
Activity type
Research Organisations
THE LEONA M. AND HARRY B. HELMSLEY CHARITABLE TRUST
United States
EU contribution
€ 0
Address
230 Park Avenue Suite 659
10169 New York
Activity type
Other
OSLO UNIVERSITETSSYKEHUS HF
Norway
EU contribution
€ 63 750
Address
Kirkeveien 166 Tarnbygget
0450 Oslo
Activity type
Higher or Secondary Education Establishments
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 88 750
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
CARDIFF UNIVERSITY
United Kingdom
EU contribution
€ 88 750
Address
Newport Road 30-36
CF24 ODE Cardiff
Activity type
Higher or Secondary Education Establishments
UNIVERSITA VITA-SALUTE SAN RAFFAELE
Italy
EU contribution
€ 63 750
Address
Via Olgettina 58
20132 Milano
Activity type
Higher or Secondary Education Establishments
NOVARTIS PHARMA AG
Switzerland
EU contribution
€ 0
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
IMCYSE SA
Belgium
EU contribution
€ 0
Address
Avenue De L Hopital 1 Giga B34
4000 Sart Tilman
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
OSPEDALE PEDIATRICO BAMBINO GESU
Italy
EU contribution
€ 1 250
Address
Piazza Sant Onofrio 4
00165 Roma
Activity type
Other