preclinical development

In the pre-clinical/translational project phase consortium facilities were set-up and prepared for GAPVAC clinical development. Already in the pre-clinical/translational stage of the project, all participants of the consortium started to contribute by tumor and plasma sample collection (WP1) and were involved scientifically in WP2, 3, 4 . The research program focused on the one hand on the identification of laboratories for biomarker and immunomonitoring tasks (WP2) which are essential for evaluation of biological activity of APVACs during the clinical trial and on the other hand on the set-up of a warehouse of glioblastoma-associated peptides as basis for patient individualized vaccination (WP3). Simultaneously, preparation of clinical documents and discussion of regulatory issues took place and scientific advice was gained (WP2). Additionally, ‘preclinical dry runs’ for identification of mutated TUMAPs with subsequent immunogenicity analyses (WP4) and GMP TUMAP manufacturing were performed in order to eliminate potential drawbacks or major feasibility concerns early in the project and to establish a functional collaboration and logistics structure between the participants.