On 13 June 2019 the Third AML-VACCiN Consortium Meeting was held in Amsterdam, The Netherlands. During this meeting progress on the overall objectives, financial status and encountered hurdles were discussed.
Good progress was reported for the preclinical mouse model experiments at consortium partner University of Bergen, using the previously developed humanized mouse model. A clear effect of DCP-001 vaccination in reducing leukaemia tumour volumes was observed, as compared to saline. Interestingly, vaccination with a lower dose of DCP-001 tends to have a more potent effect than the higher dose. These data largely expands the pre-clinical data package of DCP-001, and firmly underscores the hypothesized mode of action of DCP-001 as vaccine inducing immune responses against leukemic cells.
The implementation of the upscaled production process of the vaccine is progressing well after the transfer of the development from Eufets to DCPrime.
Also an important milestone has been achieved in the second 18 months period of the AML-VACCiN project together with partners Accelovance and Universitaetsklinikum Bonn, being that all national and local regulatory approvals were obtained for opening the first German site in Bonn. Additionally, in November 2018 the first patient has entered the clinical trial at partner VUmc. At the time of the meeting three patients have been included in the study, of which one patient already successfully finished treatment. The major hurdle in the AML-VACCiN project is the slower than expected patient recruitment. Since the previous consortium meeting last year, all efforts has been made to activate new centers to increase the recruitment rate. This has resulted in the national approval of the German and Norwegian regulatory authorities and the activation of sites in Bonn (GE) and Leipzig (GE). Furthermore sites in Mainz (GE) and Bergen (NO)) are expected to be opening soon. Additional mitigation actions, e.g. active search for new sites other than consortium participants, are in place to ensure further increase in the recruitment rate.