HEPAVAC includes innovative features across the entire spectrum of drug development:
- Key therapeutic innovation: Multi-target, multi-peptide and multi-HLA allele “off-the-shelf” vaccine for HCC complemented by an additional personalised treatment approached, representing a “hot topic” in current oncology drug development;
- Key efficacy innovation: Simultaneous activation of tumour specific cytotoxic CD8+ T cells and CD4+ T helper cells by vaccination; increased efficacy through combination of vaccination with a novel and highly potent RNA-based immune modulator (RNAdjuvant®);
- Key clinical innovation: Accomplishment of a European multi-centre randomised, controlled, phase I/II clinical trial in hepatocellular carcinoma including fully personalised treatment for a subset of patients;
- Key technology innovation: Integration of next generation sequencing (NGS) and HLA-peptidomics to assess the natural and mutated HCC HLA-peptidome of individual patients thus moving beyond current concepts of personalisation;
- Key process innovation: On-demand logistical chain for tumor analysis by NGS, transcriptomics and peptidomics analysis followed by GMP manufacturing and formulation of personalised vaccine components (small scale, short time);
- Key regulatory innovation: Development of a novel regulatory framework for actively personalised medicine.