The clinical development of DCprime’s therapeutic candidates currently focuses on treating hematological malignancies, such as acute myeloid leukemia and multiple myeloma. Both diseases have a high risk of relapse, even after initial response to chemotherapy. Repeated treatment or a bone marrow transplant are the only means currently available to control or cure these diseases, so there is a dire need to develop additional therapies. We aim to develop a new class of relapse vaccines to address this need by boosting the patients’ immune system to obtain disease control.
DCP-001 is currently being evaluated in a multi-center European Phase II trial in Acute Myeloid Leukemia (AML) patients who have responded to treatment with chemotherapy but are not able to undergo bone marrow transplantation. Patients in complete remission but with measurable residual disease (MRD) will be included. Immune responses to DCP-001 vaccination and effects on MRD will be monitored to evaluate the efficacy of this relapse vaccine.
DCP-001 has previously been evaluated in patients with AML in a Phase I clinical study with top-line data having been published in Cancer Immunology, Immunotherapy in mid 2018. The primary objectives of the study (feasibility and safety) were achieved, with 10 out of the 12 patients completing the vaccination program. Treatment was well-tolerated and generated both cellular and humoral immune responses.
For more information on the Phase 1 trial, please go to www.clinicaltrials.gov.
DCP-001 has been granted Orphan Drug Status in the EU.
DCprime intends to expand the current development plan for DCP-001 further and add a combination therapy trial with a hypomethylating agent in patients with AML or Myelodysplastic syndrome (MDS) by the end of 2019. Clinical data from this as well as the ADVANCE-II trial is expected to become available during the course of 2020.
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 a relapse vaccine in multiple myeloma is being investigated.
In addition, there are a number of ongoing preclinical programs investigating novel vaccination approaches for solid tumors.