The key feature of DCPrime’s technology is that the DCOne® platform provides the opportunity to produce dendritic cell-based vaccines as off-the-shelf allogeneic products, and thus bypasses the pitfalls of autologous products, in particular heterogeneity and high variability. Nevertheless, large-scale production of such cellular products is associated with many challenges, including acceptability by regulatory authorities, and we therefore invest continually in developing a GMP manufacturing process which lends itself to further scale-up. Together with EUFETS GmbH, a BioNTech company based in Germany, we are involved in preparing for our next clinical study in AML patients with DCP-001. This involves both up- and down-stream processing activities, plus development of many assays for in-process control and quality control. In addition, we are developing DCOne®-based vaccines loaded with known tumor antigens for other cancer types. Production of DCOne®-derived vaccines for large numbers of patients across a broad range of cancer types is DCPrime’s overall main goal, and we consider this process technology investment critical for achieving this goal.
Successful completion of Phase I/IIa clinical trial for DCP-001
DCPrime’s lead program is targeting AML with DCP-001, the first product that has been tested in a Phase I/IIa clinical trial in patients with AML. This was an open label feasibility and safety dose escalation study, and it has shown promising applicability of the vaccine: it was safe and well tolerated in all patients, and multi-functional immune responses were induced. Also, specific T cell responses against some of DCP-001’s antigens were induced, as was predicted by pre-clinical data. Although the study was not designed to show a survival advantage, several patients show remarkably long survival, and patients in first remission responded best. Based on these data, we are now preparing a Phase II study in post-remission AML patients.
Last updated: oktober 5, 2015