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Emerging translational safety technologies and tools for interrogating human immuno-biology

For full details of the topic, please see the call text on the IMI website.

This topic aims to establish a public-private consortium that will enhance translational safety assessment approaches for immunomodulatory therapeutics (spanning oncology and non-oncology indications), with an emphasis on evaluating human-relevance.

The following objectives are within the scope of this proposal:

  1. development of innovative comparative (cross-species) in situ and ex vivo molecular, biochemical tools and cellular profiling of immune cells (including patient-derived clinical samples) and association with functional/phenotypic endpoints to enable;
  2. establishment, refinement and validation of non-clinical tools and models to enable the development of novel classes of immunomodulatory medicines supporting in vitro-in vivo and cross-species translation.

For full details of the topic, please see the call text on the IMI website.

There is an urgent need to better understand inherent risks of innovative therapeutics for immuno-oncology and immuno-inflammatory disease indications including cytokine release syndrome, infection, malignancy and autoimmunity during early (non-clinical) stages of drug development. The toxicities induced by immunomodulatory therapeutics in patients are often not detected in the young healthy animal models that are routinely used for toxicology studies either due the lack of expression of appropriate drug targets/pathways or due to differences in drug target genetics, expression and functions between animal models and the intended patient populations. Thus, innovative translational safety assessment tools, technologies, models and resources are needed to facilitate the development of novel immunomodulatory drugs (either immunostimulatory or immunosuppressive).

For full details of the topic, please see the call text on the IMI website.

The action generated by this topic will ultimately help deliver safer medicines to patients via:

  • provision of new tools and models to enable a better understanding of the inherent safety risks of immunomodulatory therapeutics;
  • improvement of drug development processes and regulatory assessments for immunomodulatory therapeutics;
  • better definition of limitations in the translatability of non-clinical test systems to patients and will also contribute to the principles of the 3Rs.

Small and medium-sized enterprises (SMEs) can be of great benefit to IMI2 JU projects. Their involvement in the action might offer a complementary perspective to industry and academia, and help deliver the long-term impact of the action.