Project description
Research platform for safer immunomodulating therapy
Modulation of the immune system is emerging as an attractive approach for treating a plethora of conditions from immune-mediated diseases to cancer. However, responses in clinical trials have been variable, underscoring the need for better biomarkers, endpoints and monitoring approaches. Towards this goal, the EU-funded imSAVAR project will develop a platform for testing the safety and efficacy of immunomodulators. Researchers will work on novel assays, reliable models and predictive biomarkers to improve the safety of immunotherapy. In collaboration with big pharmaceutical companies, the ultimate goal of the imSAVAR effort is to transfer the knowledge from preclinical models into first-in-human studies.
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.
Fields of science
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
80686 Munchen
Germany
See on map
Participants (27)
07747 Jena
See on map
7522 NB Enschede
See on map
3631 Maasmechelen
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
2333 ZA Leiden
See on map
04109 Leipzig
See on map
30625 Hannover
See on map
72074 Tuebingen
See on map
6020 Innsbruck
See on map
63225 Langen
See on map
4354 ESCH SUR ALZETTE
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
4365 ESCH-SUR-ALZETTE
See on map
97080 Wurzburg
See on map
22100 Lund
See on map
97076 Wurzburg
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
0313 Oslo
See on map
07745 Jena
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Participation ended
02142 Cambridge Ma
See on map
HG3 IPY Harrogate
See on map
55218 Ingelheim
See on map
10281 NEW YORK
See on map
64293 Darmstadt
See on map
4056 Basel
See on map
4070 Basel
See on map
94250 GENTILLY
See on map
91190 GIF-SUR-YVETTE
See on map
67400 Illkirch-Graffenstaden
See on map
08889 Whitehouse Station Nj
See on map