Main Objectives of HEPAVAC will be:
- Demonstration of safety, biological efficacy and first indication of clinical efficacy for a novel, highly innovative vaccine approach by a first-in-man randomised, controlled clinical trial addressing the high unmet medical need of HCC patients;
- Identification of novel and relevant HCC-associated antigens by analysis of HLA class I binding epitopes naturally processed and presented on primary tumour tissues from HCC patients to activate cytotoxic T cells (CTL) involved in killing tumour cells;
- Complementation of the vaccination approach by novel and relevant HLA class II-restricted antigens to activate CD4+ T helper cells to co-stimulate tumour specific CTL;
- Design of an “off-the-shelf” multi-peptide formulation comprising multiple class I and class II-restricted tumor associated epitopes based on in vitro predicted immunogenicity and physicochemical compatibility (the HEPAVAC vaccine). Using this multi-target approach tumour evasion becomes an improbable scenario and immune therapy can induce sustainable effects;
- Set-up of a platform for personalised booster vaccination by establishing methods for an on-demand patient-specific antigen identification and formulation, as well as required logistic processes;
- Proof of concept for the MoA of the HEPAVAC HCC vaccination approach via a comprehensive centralised immune monitoring program, including the extensively standardized multi-centric collection of biological patient samples;
- Proof-of-concept for the combination of the peptide-based vaccination approach and a novel immunomodulator (RNAdjuvant®).