DCPrime’s Phase I/IIa trial with dendritic cancer vaccine in AML meets all clinical endpoints
28 May 2013, Leiden, the Netherlands – Cancer vaccine company DCPrime today announced the successful completion of its Phase I/IIa study in acute myeloid leukemia (AML). The study establishes the safety and feasibility of vaccination with DCPrime’s lead product DCP-001, and shows clear evidence of a positive, vaccination induced immune response. Remarkably, several patients showed prolonged survival compared to historic expectations.
“Given the stage of disease of these patients, the results of our study are compelling, and provide us with a solid basis to advance our lead product DCP-001 to a multicenter Phase II study in a larger patient population and continue the development of this promising treatment for AML,” said Marcel Zwaal, CEO.
“We are very pleased with the encouraging results from this study,” said Prof. Dr. Arjan van de Loosdrecht, principal investigator and professor of hematology at VUmc. “Dendritic cell vaccines such as DCP-001 may offer AML patients a real and much needed therapeutic alternative in the near future. We look forward to working with the Company to further develop DCP-001 in a multicenter randomized Phase II trial.”
About the study
The Phase I/IIa trial was an open label, non-randomized, dose escalation study that enrolled 12 patients to determine the safety and feasibility of DCP-001 in a dose-escalating schedule of 4 vaccinations with 2 weeks intervals. Patients were elderly, at high risk of relapse, and ineligible for standard post-remission therapy. DCP-001 vaccination triggered a broad, systemic T-cell and B-cell immune response, and T cell responses against specific leukemia antigens were noted in particular in patients that have prolonged survival compared to historic expectations. The patients showed only local injection site reactions and no product related adverse events were observed. The study was conducted at the Department of Hematology of the Vrije Universiteit medical center (VUmc), Amsterdam, the Netherlands. Principal investigators were Gert Ossenkoppele, MD, PhD, professor of hematology and head of the VUmc Department of Hematology, and Arjan van de Loosdrecht, MD, PhD, professor of hematology.
DCPrime develops off-the-shelf dendritic cell-based vaccines for a broad range of cancer types, based on its unique, proprietary technology platform, DCOne™. DCOne-based dendritic cell vaccines, in some indications loaded with cancer antigens for targeted treatment, are used as standardized, therapeutic products. The platform combines the power of dendritic cell-based vaccines with the advantages of allogeneic stimulation of the immune system, and the simple logistics of off-the-shelf products. DCPrime has a commercial scale manufacturing process for DCOne-based vaccines in place and is developing additional products for solid cancers using antigen loaded DCOne-based vaccines.
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