Data will be available from in-vitro pre-clinical tests on the pharmacodynamic activity of the fusion vaccines. This test will verify the capacity of the fusion vaccine to present certain tumour-antigen derived peptides corresponding to antigens present in the fused cancer cells. BruCells has met with the Dutch MEB for a Scientific Advice Meeting on January 10, 2008 in The Hague. The Dutch authorities consider that the proposed in-vitro pre-clinical tests are adequate to check the pharmacodynamic activity of the fusion vaccines and that no animal model tests would be necessary.
In vitro priming of tumor-antigen specific T-cells
In vitro recognition of fusion vaccine by T-cells