science
Personalized medicine is an intense focus in current oncology drug development. Typically, personalization is discussed as the biomarker-guided stratified use of a standard drug product (e.g. use of Herceptin in Her2/neu-positive breast cancer patients). The Regulatory Research Group (RRG) of the Association of Cancer Immunotherapy (CIMT) has defined a novel level of personalization, the biomarker-guided manufacturing of a vaccine composition specific for each individual patient. Because this kind of personalization requires a sophisticated analysis of genomic, proteomic or peptidomic molecular biomarkers that will actively determine the drug product composition for each patient, it is termed “active personalization”, and in the case of cancer immunotherapy“ actively personalized vaccines” or or APVAC.
GAPVAC is among the first clinical projects in the direction of fully active personalized medicine, where patients are treated based on specific characteristics of their individual disease with the long term objective to extend the clincial benefit of patients. Within the GAPVAC project several key innovations are combined to accomplish a clinical study, where the medication of each patient is manufactured on-demand. To meet this challenge, the project requires close collaboration of all project partners and a diligent preparation of the clinical trial in the preclinical phase of the project.