Project description
Towards innovative therapies against type 1 diabetes
Type 1 diabetes (T1D) is an autoimmune disorder associated with the destruction of pancreatic islet beta cells, leading to little or no insulin production. The EU-funded INNODIA HARVEST project is undertaken by a large network of experts that aim to prevent or arrest T1D through innovative strategies. The project builds on the strong foundations of the INNODIA consortium, its origin. Partners will perform a series of intervention trials to study the mechanisms of T1D, identify biomarkers and study pathways associated with disease pathobiology. Through a beta-cell focussed and an immune-focussed intervention trial, the team hopes to deliver key knowledge for new combination therapies and to establish discovery pipelines for future T1D therapeutics. The people living with T1D remain at the center of INNODIA HARVEST, driving the implementation of patient-centered results, shaping our clinical trials and making meaningful change in the disease perspective.
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.
Fields of science
- medical and health sciencesbasic medicinepharmacology and pharmacydrug discovery
- agricultural sciencesagriculture, forestry, and fisheriesagriculturehorticulturefruit growing
- medical and health sciencesclinical medicineendocrinologydiabetes
- medical and health sciencesbasic medicineimmunology
- medical and health sciencesmedical biotechnologytissue engineeringartificial pancreascontinuous glucose monitors
Keywords
Programme(s)
Topic(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
3000 Leuven
Belgium
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Participants (41)
CB2 1TN Cambridge
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8010 Graz
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1050 Bruxelles / Brussel
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1165 Kobenhavn
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3400 Hillerod
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75654 Paris
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00014 Helsingin Yliopisto
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90014 Oulu
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20014 Turku
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30173 Hannover
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85764 Neuherberg
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01069 Dresden
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89081 Ulm
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53100 Siena
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66013 Chieti
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56126 Pisa
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1210 Luxembourg
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EX4 4QJ Exeter
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40 055 Katowice
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1000 Ljubljana
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Participation ended
1015 LAUSANNE
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Participation ended
6525 XZ Nijmegen
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2333 ZA Leiden
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WC2R 2LS London
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22100 Lund
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
291 89 Kristianstad
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31000 Toulouse
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
65929 Frankfurt Am Main
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2880 Bagsvaerd
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WC1A 1DG LONDON
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RG21 4FA Basingstoke
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10281 NEW YORK
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10169 New York
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0450 Oslo
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OX1 2JD Oxford
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CF24 0DE Cardiff
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20132 Milano
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4056 Basel
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4032 SART TILMAN
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
00165 Roma
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6525 GA Nijmegen
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