imSAVAR

IMMUNE SAFETY AVATAR – nonclinical mimicking of the immune system effects of immunomodulatory therapies (Horizon 2020 – European reserch project)

The EU Horizon 2020 project imSAVAR  started 1th December 2020. IZBI will contribute by designing cellular and molecular biomarkers for early detection of adverse effects. imSAVAR brings together more than 20 partners from Europe.

The vision of imSAVAR is to develop a platform for integrated nonclinical assessmrnts of immunomodulatory therapy safety and efficacy. Existing nonclinical models do not adequately represent the complexity of the immune system and its interactions i 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:

  1. understanding the value of nonclinical models for predicting efficacy and safety of immunomodulators incorporating cellular high throughput assys, complex organisms models and micro physiological systems
  2. developing new endpoints and better monitoring approaches for immune function tests
  3. designing cellular and molecular biomarkers for early detection of adverse effect

The platform imSAVAR will be based upon case studies for prioritized therapeutic modalities and has been built around institutes of the Frauenhofer-Gesellschaft which has strong track records in applied science and in particular toxicology. The consortium wil improve the prediction of the transferability of safety and efficacy of immunmodulators from pre-clinical models to first-in-human studies in collaboration with the proivate sector, pharma, regulators and technical providers.

We will share experiance on customized models that can be deployed, establish the nessesary 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.

IZBI role in ImSAVAR

IZBI will contribute to WP4 (Computational Immunology, Marker) and WP5 (Data management)

– immune-biology mechanisms, genomic regulation and related adverse effects of immune therapy, characterizing immune-phenotypes

– omics analyses, machine learning, SOM portrayal of omics data sets, single cell transcriptomics, feature selection and knowledge mining

– data management providing and analysing omics data set

project leader at IZBI Dr. Henry Löffler Wirth

duration 01.12.2019 – 30.11.2025

joint project / third-party founding

coodinator: Fraunhofer Gesellschaft zur Förderung der angewandten Forschung e.V. München / Germany

click here for official imSAVAR-project-homepage: https://imsavar.eu/