HepaVac-101 first-in-man therapeutic cancer vaccine phase I/II clinical trial for hepatocellular carcinoma patients.

TPS3135Background: HCC is the third leading cause of death from cancer globally with an extremely variable 5-year survival rate. The HepaVac-101 phase I/II, first-in-man, therapeutic cancer vaccine single-arm clinical trial is performed as part of the HepaVac project, funded by the European Commission’s 7th Framework Program under the Grant Agreement Nr. 602893 (www.hepavac.eu). The HepaVac-101 trial identification numbers are NCT03203005 (Clinical trials.gov) and 2015-003389-10 (EudraCT). and Methods: The therapeutic cancer vaccine IMA970A is a multi-peptide-based HCC vaccine composed of 16 newly discovered and overexpressed tumor-associated peptides (TUMAPs) directly identified from resected HCC tissues. Of these TUMAPs, 7 are restricted to HLA-A*02, 5 to HLA-A*24 and 4 to HLA class II. CV8102 is a novel RNA based immunostimulatory agent inducing a balanced Th1/Th2 immune response. A total of 40 patients with very early, early and intermediate stage of HCC are enrolled to be treated with a single pre-va...