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Immune Safety Avatar: nonclinical mimicking of the immune system effects of immunomodulatory therapies

Objective

The vision of Immune Safety Avatar (imSAVAR) is to develop a platform for integrated nonclinical assessments of immunomodulatory therapy safety and efficacy. Existing nonclinical models do not adequately represent the complexity of the immune system and its interactions in both immunoncology and immunmediated diseases. They also do not accurately reflect the diversity of response to new therapies that is seen in clinical medicine.
We will, thus, constantly refine existing and develop new nonclinical models with the final goal of validation aiming at: (i) understanding the value of nonclinical models for predicting efficacy and safety of immunomodulators incorporating cellular high throughput assays, complex organisms models and micro physiological systems, (ii) developing new endpoints and better monitoring approaches for immune function tests, and (iii) designing cellular and molecular biomarkers for early detection of adverse effects. The platform imSAVAR will be based upon case studies for prioritized therapeutic modalities and has been built around institutes of the Fraunhofer-Gesellschaft which has strong track records in applied science and in particular toxicology. The consortium will improve the prediction of the transferability of safety and efficacy of immunomodulators from pre-clinical models to first-in-human studies in collaboration with the private sector, pharma, regulators and technology providers. We will share experience on customized models that can be deployed (w.r.t. the 3Rs principles), establish the necessary infrastructure, conduct the analyses and provide wider disease domain expertise. This conjoint effort assures that the platform imSAVAR constantly benefits the field of immune safety evaluation, and will generate opportunities for European businesses. A guiding principle of this consortium is the meaningful engagement of multiple stakeholders including patients and regulators. A multi-stakeholder community will be established.

Call for proposal

H2020-JTI-IMI2-2018-15-two-stage
See other projects for this call

Funding Scheme

IMI2-RIA - Research and Innovation action

Coordinator

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.
Address
Hansastrasse 27C
80686 Munchen
Germany
Activity type
Research Organisations
EU contribution
€ 3 720 803,75

Participants (27)

Universitätsklinikum Jena
Germany
EU contribution
€ 519 475
Address
Bachstraße 18
07743 Jena
Activity type
Higher or Secondary Education Establishments
UNIVERSITEIT TWENTE
Netherlands
EU contribution
€ 519 362,50
Address
Drienerlolaan 5
7522 NB Enschede
Activity type
Higher or Secondary Education Establishments
BIOSCI CONSULTING BVBA
Belgium
EU contribution
€ 288 750
Address
Weg Naar Geneuth 95
3631 Maasmechelen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 419 687,50
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
UNIVERSITAET LEIPZIG
Germany
EU contribution
€ 706 775
Address
Ritterstrasse 26
04109 Leipzig
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE HOCHSCHULE HANNOVER
Germany
EU contribution
€ 568 650
Address
Carl-neuberg-strasse 1
30625 Hannover
Activity type
Higher or Secondary Education Establishments
EBERHARD KARLS UNIVERSITAET TUEBINGEN
Germany
EU contribution
€ 724 250
Address
Geschwister-scholl-platz
72074 Tuebingen
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
EU contribution
€ 366 485
Address
Christoph Probst Platz 1
6020 Innsbruck
Activity type
Higher or Secondary Education Establishments
BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL
Germany
EU contribution
€ 602 556,25
Address
Paul-ehrlich-strasse 51-59
63225 Langen
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
INFORMATION TECHNOLOGY FOR TRANSLATIONAL MEDICINE (ITTM) SA
Luxembourg
EU contribution
€ 340 000
Address
9 Avenue Des Hauts-forneaux
4362 Esch-sur-alzette
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITE DU LUXEMBOURG
Luxembourg
EU contribution
€ 423 400
Address
2 Avenue De L'universite
4365 Esch-sur-alzette
Activity type
Higher or Secondary Education Establishments
UNIVERSITAETSKLINIKUM WUERZBURG - KLINIKUM DER BAYERISCHEN JULIUS-MAXIMILIANS-UNIVERSITAT
Germany
EU contribution
€ 978 100
Address
Josef-schneider-strasse 2
97080 Wurzburg
Activity type
Higher or Secondary Education Establishments
LUNDS UNIVERSITET
Sweden
EU contribution
€ 396 771,25
Address
Paradisgatan 5C
22100 Lund
Activity type
Higher or Secondary Education Establishments
T-CURX GMBH
Germany
EU contribution
€ 211 250
Address
Friedrich-bergius-ring 15
97076 Wurzburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITETET I OSLO
Norway
EU contribution
€ 124 250
Address
Problemveien 5-7
0313 Oslo
Activity type
Higher or Secondary Education Establishments
DYNAMIC42 GMBH
Germany
EU contribution
€ 88 750
Address
Winzerlaer Str 2
07745 Jena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BLUEBIRD BIO INC.
United States
EU contribution
€ 0
Address
60 Binney Street
02142 Cambridge Ma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
COVANCE LABORATORIES LTD
United Kingdom
EU contribution
€ 0
Address
Otley Road
HG3 IPY Harrogate
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BOEHRINGER INGELHEIM INTERNATIONALGMBH
Germany
EU contribution
€ 0
Address
Binger Strasse
55218 Ingelheim
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
MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN
Germany
EU contribution
€ 0
Address
Frankfurter Strasse 250
64293 Darmstadt
Activity type
Private for-profit entities (excluding 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)
F. HOFFMANN-LA ROCHE AG
Switzerland
EU contribution
€ 0
Address
Grenzacherstrasse 124
4070 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
EU contribution
€ 0
Address
Pierre Brossolette 1
91380 Chilly Mazarin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INSTITUT DE RECHERCHES SERVIER
France
EU contribution
€ 0
Address
3 Rue De La Republique
92150 Suresnes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TRANSGENE SA
France
EU contribution
€ 0
Address
Boulevard Gonthier D Andernach - Parc D'innovation
67405 Illkirch-graffenstaden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MERCK SHARP & DOHME CORP
United States
EU contribution
€ 0
Address
One Merck Drive
08889 Whitehouse Station Nj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)