Periodic Reporting for period 5 - INNODIA (Translational approaches to disease modifying therapy of type 1 diabetes: an innovative approach towards understanding and arresting type 1 diabetes – Sofia ref.: 115797)
Reporting period: 2019-11-01 to 2020-10-31
After major efforts at the start of INNODIA focusing on standardization of sampling protocols and ethical approvals, all clinical partners (WP 1) are now recruiting at full speed, resulting in an exponential increase of recruitment to a total of 4021 participants. Our clinical network is expanding, with new partners joined INNODIA and satellites of established INNODIA partners now present in 6 countries. All clinical centers are accredited and have been trained for use of the INNODIA eCRF.
As a cornerstone for the working of INNODIA, we have conceived the modular interrogation platforms for analysis of cellular and molecular features of T1D for beta-cell and immune cells, proteomes, lipidomes and metabolomes (WP2). Six Immune Hubs or Sub-Hubs are installed and active. We completed successfully an integrated multi-omics natural history study on samples of newly diagnosed (ND) participants. Work has been initiated on the ‘First 100 unaffected family members’. In addition, first distribution of samples for analysis of specific biomarkers (discovery research, collaboration WP3) has happened. Also, WP4 has elaborated approaches for GDPR-compliant analysis of the results of WP2 analyses embedded with clinical WP1 parameters in the INNODIA database by partners.
WP3 aims to gain better insight in the way beta-cells are destroyed in T1D. Development of novel biomarkers in particular is being pursued. Our collaborative research, focusing on the interplay between beta-cell and immune system has progressed in period 5. Despite being forced to homework for many researchers due to COVID, many virtual interactions took place, leading to fortification of existing collaborations and an amazing number of new INNODIA WP3 publications, mostly the result of collaborations between 2 or more INNODIA partners. We used the virtual annual meeting of EASD 2020 as the launching platform for many INNODIA presentations, with 14 oral and poster presentations by INNODIA researchers. Of importance, novel biomarkers issuing from WP3 work have now been incorporated in the multi-omics analysis performed on the ‘first ND 100’ described under WP2.
WP4 is devoted to the establishment of an integrative systems biology platform and in silico modelling for T1D. A crucial role for WP4 in period 5 has been the work in the biomarker identification effort on ‘the first 100’, preparing INNODIA for the first integrative analysis effort of clinical with multi-omics data and adaptation of the whole system for clinical trials. In this regard, WP4 has been instrumental in expanding the eCRF system to comply with regulatory requirements to be used in intervention clinical trials,
As INNODIA moved to the next level (clinical trial initiation and execution), the role of WP5 grows. We have progressed more rapidly than foreseen and are already running the first trial. To streamline our efforts, we have taken several steps: 1) Accreditation of clinical centers. All centers have been accredited in 2017/2018 and are being followed up for quality in recruitment. New centers were accredited in 2020, and re-accreditation is ongoing; 2) Establishment of a Masterprotocol on the backbone of which clinical trials run and that allows adaptive and novel trial design. This has been finalized and obtained positive advice in February 2020; 3) Establishment of a Clinical Trial Prioritization Committee (ICTPC) that handles prioritization of offered trials to INNODIA; 4) Establishment of the Clinical Coordination Centre to oversee the activities related to the clinical trials running in INNODIA. In 2020, the first INNODIA trial MELD-ATG (KU Leuven as sponsor, UCAM as coordinator and Sanofi providing study drug) has been initiated in September 2020 with first participant recruited on 15 December 2020.
WP6 groups all the work of managing and running INNODIA. As INNODIA grows in partners, in recruitment and in scientific output, we are stepping up the management of INNODIA. Next to overall project management, specific attention has been dedicated in 2020 to communication on the aspects related to the COVID-19 pandemic and increasing visibility of INNODIA network. Moreover, expansion (in budget, partners and projects), longterm sustainability and dealing with Brexit were prioritized. We stepped up communication to partners and increased the use of external communication channels to promote our work.