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

Deliverables

Preliminary irAOP - CPI Mo

Same as D2.1, but for Checkpoint inhibitors

CAR-T & BITE immune safety assessment research roadmap

A document that is based upon the outcome of the imSAVAR workshops on CAR-T/BiTE immune safety assessment. It will contain a description of the highest priority irAOPs for CAR-T/BiTE MoAs, input from different stakeholders including regulators. This document will also highlight the most important areas where further research and development is needed with specific representation of what is planned for the effort in imSAVAR

Dissemination materials

A websiste, overview, slides, and a dynamic set of messages for use in describing and disseminating the outputs of imSAVAR and for building the stakeholder community.

TReg-IL2 immune safety assessment research roadmap

A document that is based upon the outcome of the imSAVAR workshop on TR-IL2 MoA. It will contain a description of the highest priority irAOPs for TR-IL2 MoA, and the input from different stakeholders including regulators. This document will also highlight the most important areas where further research and development is needed with specific representation of what is planned for the effort in imSAVAR

Preliminary irAOP - CAR-T & BiTE MoAs

In order to inform the attendees for the workshop and to form the basis for the assessment roadmap the preliminary irAOPs will be pathways of the most different adverse outcomes for CAR-T and BiTEs. These will be defined by the consortium members and supplemented by research and available data where possible.

Preliminary irAOP - IL2-TREG

In order to inform the attendees for the workshop and to from the basis for the assessment roadmap the preliminary irAOPs will be pathways of the most different adverse outcomes for IL2-TREG MoA. These will be define by the consortium members and supplemented by research and available data where possible.

1st imSAVAR workshop

This workshop will be multi-stakeholder, multi-disciplinary workshop to define irAOPs specific case study for CAR-T cells and CD3-targeted bispecific antibodies. Within this workshop the gaps for where models need to be refined or new models developed.

Distributed network biobanking system

A system the process of know which types of samples are available where and support the process of accessing them.

Network of disease domain providers for providing samples

A defined network of centres and defined processes for accessing samples taking into consideration ethics and data privacy concerns. The report on this deliverable will include a description of how this network was used in during the implementation of imSAVAR

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