project

For a successful accomplishment of the GAPVAC project the consortium implemented a number of key innovations. This could only be achieved by the close collaboration of all participating parties in a complex process ranging from the surgery of patients, genomic tumor analyses, peptide antigen identification, manufacturing of the individualized drug, vaccination of the respective patient and finally monitoring of the disease and the immune system of patients on several levels.

project

GAPVAC Key Innovations:

  • Therapeutic innovation:
    Personalized medicine as intense focus in current oncology drug development
  • Technology innovation:
    Integration of next-generation-sequencing and HLA peptidomics to assess patients’ mutanome (the mutated HLA-peptidome)
  • Process innovation:
    On-demand GMP manufacturing of APVACs
  • Regulatory innovation:
    Development of a regulatory framework for actively personalized medicine
  • Management innovation:
    Accomplishment of a European fully personalized phase I clinical trial in glioblastoma
  • Monitoring innovation:
    Individualized immune and biomarker monitoring of vaccine success

Project plan

GAPVAC focused on the development of a fully and actively personalised vaccination approach, in which patients are treated based on specific characteristics of their individual disease. To assess this, GAPVAC was divided into a section for pre-clinical/ translational development and a subsequent clinical phase I trial to assess safety, feasibility and immunogenicity of APVACs. The project plan covered eleven work packages: WP1-4 covering the pre-clinical phase of the project, WP5-9 clinical trial and WP10-11 the management of the consortium and the dissemination plan.