DCprime announces first patient dosed in phase 2 ADVANCE-II study with DCP-001 in patients with Acute Myeloid Leukemia
Leiden, The Netherlands, 15 November 2018 – DCprime bv, a clinical stage biotechnology company focused on cancer immunotherapies, announces that the first patient has been dosed with DCP-001 in a phase 2 study, called ADVANCE-II. Patients with Acute Myeloid Leukemia (AML) in complete remission after induction therapy but with persistence of measurable residual disease (MRD) will be included in this multi-centre study. Effects on MRD and cellular and humoral immune responses will be monitored to evaluate the efficacy of this cancer vaccine.
Prof Dr Arjan van de Loosdrecht, Amsterdam UMC, VU University Medical Center, The Netherlands commented: “We are very glad that the first patient was treated with the DCP-001 vaccine in the ADVANCE-II study. This is an important study to show the potential efficacy of this cancer vaccine in patients who have measurable residual disease and are at great risk of disease relapse.”
The study is currently open for recruitment of patients in The Netherlands and Germany, with additional request for regulatory approval in Norway, Sweden and Finland pending.
Dr Jeroen Rovers, Chief Medical Officer at DCprime added: “Start of the phase 2 study marks an important step for DCprime in development of its technology. It will provide additional evidence whether DCP-001 can initiate immunological control of aggressive cancers, such as AML. We are grateful to all investigators and patients committed to contribute to this study.”
Last month data from the phase 1 study with DCP-001 in AML were published in Cancer Immunology, Immunotherapy (van de Loosdrecht, A.A., van Wetering, S., Santegoets, S.J.A.M. et al. Cancer Immunol Immunother (2018) 67: 1505.).
About DCprime bv
DCprime is a privately owned, clinical stage biotechnology company focused on cancer immunotherapies. Founded in 2005, DCprime currently develops cell based cancer vaccines based on its proprietary technology platform DCOne®, with lead DCOne® asset DCP-001 being studied in patients with acute myeloid leukemia (AML). A completed Phase I study has demonstrated that DCP-001 is generally safe and capable of inducing a broad immune response. DCprime has received orphan drug designation from the European Medicines Agency for DCP-001 in AML and has commenced a multi-centre Phase II trial. DCprime intends to develop DCOne®-based vaccines in other cancer indications, including multiple myeloma and solid tumours. For more information, visit www.dcprime.com.
This phase 2 study is a European collaboration between several hospitals and companies (AML-VACCiN consortium) and is support by an European Horizon grant. The objective of the study is to assess safety and efficacy of vaccination with DCP-001 in patients with Acute Myeloid Leukemia, who are in complete remission, but have measurableresidual disease (MRD). A total of 20 patients will be treated, with monitoring of MRD and immune responses throughout the study. The study is conducted in hospitals in Finland, Germany, Norway, Sweden and The Netherlands.
For more information about the phase 2 ADVANCE-II clinical trial of DCP-001, please visit www.clinicaltrials.gov, (Identifier: NCT03697707).
Dr Erik Manting
CEO DCprime bv