Rezultaty
Same as D2.1, but for Checkpoint inhibitors
CPI immune safety assessment research roadmapSame as D23 but for Checkpoint inhibitors
CAR-T & BITE immune safety assessment research roadmapA 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
1st iteration in vivo and in vitro models IL-2 MoaThis will be a set of refined in vivo models and in vitro that have been initially refined based upon the outcome of the imSAVAR workshop on IL2 MoA This will be a report that defines the refinements and describes and confirmatory work that has been done
Dissemination materialsA 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 roadmapA 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 MoAsIn 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-TREGIn 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 iteration refined in vivo & in vitro model readouts IL-2 MoAThis will be a set of improved model readouts that have been initially refined based upon the outcome of the imSAVAR workshop on IL 2 MoA This will be a report that defines the refinements and describes and confirmatory work that has been done
3rd imSAVAR workshopSame as 13 but for IL2 Treg MoA
1st imSAVAR workshopThis 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.
1st iteration in vitro & MPS modelsThis will be a set of models that have been initially refined based upon the outcome of the imSAVAR workshops on the different in vitro MPSs models developed to address the gaps in the irAOPs This will be a report that defines the refinements and describes and confirmatory work that has been done
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 samplesA 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
1st iteration of advanced immune cell profilingA dataset of high throughput molecular profiling datasets. The exact molecular profiling techniques will be based upon the outcomes of the workshops, the progress in model, development, and the criteria established in the analysis plans. This will have undergone initial bioinformatic processings to produce a dataset that is useful for identifying biomarkers as well as mechanistic insights from the models being refined and developed in imSAVAR.
A data catalogue of analysed and interpreted high throughput molecular profiling datasets to reveal molecular mechanism leading to irAEs. The exact modelling methods will be based upon the type of profiling data generated in Task 4.2. and the criteria established in the analysis plans.
Publikacje
Autorzy:
Maulana, Tengku Ibrahim; Kromidas, Elena; Wallstabe, Lars; Cipriano, Madalena; Alb, Miriam; Zaupa, Cécile; Hudecek, Michael; Fogal, Birgit; Loskill, Peter
Opublikowane w:
Advanced Drug Delivery Reviews, 2021, Strona(/y) 281-305, ISSN 0169-409X
Wydawca:
Elsevier BV
DOI:
10.1016/j.addr.2021.03.015
Autorzy:
Henry Loeffler-Wirth, Michael Rade, Arsen Arakelyan, Markus Kreuz, Markus Loeffler, Ulrike Koehl,
Kristin Reiche, and Hans Binder
Opublikowane w:
Frontiers in Immunology, 2022, ISSN 1664-3224
Wydawca:
Frontiers Media SA
DOI:
10.3389/fimmu.2022.994885
Autorzy:
Toralf Kirsten, Frank A. Meineke, Henry Loeffler-Wirth, Christoph Beger, Alexandr Uciteli, Sebastian Stäubert, Matthias Löbe, René Hänsel, Franziska G. Rauscher, Judith Schuster, Thomas Peschel, Heinrich Herre, Jonas Wagner, Silke Zachariae, Christoph Engel, Markus Scholz, Erhard Rahm, Hans Binder, Markus Loeffler
Opublikowane w:
Methods of Information in Medicine, 2022, ISSN 0026-1270
Wydawca:
Schattauer
DOI:
10.1055/a-1914-1985
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