Clinical development of DCOne® initially has focused on treatment of haematological malignancies, specifically acute myeloid leukemia (AML) with lead asset DCP-001. This disease is characterized by high risk of relapse, even after initial response to chemotherapy. Repeated treatment or bone marrow transplantation currently are used to control or cure the disease. However, there is need for additional therapies to improve treatment outcome, specifically those with limited side effects. DCP-001 could provide a successful strategy to boost the patients’ immune system and result in lasting disease control.
Lead product DCP-001 has been tested in patients with AML in a phase I clinical study. Several doses have been shown safe to administer, with initial responses encouraging (ClinicalTrials.gov Identifier: NCT01373515). DCP-001 has Orphan Drug Status in the EU.
In collaboration with a consortium of academic hospitals throughout Europe, DCP-001 is being trialed in a Phase II trial ADVANCE II in AML patients who have responded almost completely to treatment with chemotherapy but are not able to undergo bone marrow transplantation. Details on this ADVANCE II study as well as participating hospitals under the Horizon2020 AML-VACCiN programme can be found at www.amlvaccin.eu.
Based on the same principle of the prevention of relapse and supported by preclinical data (Leaf et al., J Immunother. 2017 Nov/Dec;40(9):315-322), the utility of DCOne® in multiple myeloma is being investigated. In addition, ongoing are a number of preclinical programmes investigating DCOne® based cancer-specific vaccine formulations for solid tumours.