DCprime is shaping the field of relapse vaccines. We are currently advancing our clinical pipeline to delay or prevent cancer recurrence in hematological and solid tumors and also investigating novel vaccination concepts in various oncology indications.
DCP-001 has been granted Orphan Drug Status in the US and the EU.
Development in hematology
Phase I in AML demonstrated safety and feasibility and promising signs of efficacy
DCP-001 has previously been evaluated in patients with Acute Myeloid Leukemia (AML) in a Phase I clinical study with top-line data having been published in Cancer Immunology, Immunotherapy in mid-2018 and long-term follow-up and survival data having been presented at the ASH 2019 conference. 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.
Phase II in AML is currently ongoing
Based on a successful Phase I study, DCP-001 is currently being evaluated in a multi-center European Phase II trial in 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.
The term Measurable Residual Disease or “MRD” reflects whether a patient treated for AML still carries a small of amount of tumor cells, which can be detected via highly sensitive molecular biological techniques. MRD strongly correlates with the probability of tumor recurrence.
The MRD+ status is associated with a high risk of relapse while staying MRD- or MRD-free transforms the patient’s prognosis and relapse-free survival (RFS). Limited options exist to treat residual disease and stay MRD-free or convert patients from MRD+ to MRD-free. Ongoing efforts worldwide to validate MRD as a surrogate endpoint for accelerated regulatory approval have led to a first FDA approval based on MRD in 2018 with blinatumomab in ALL. DCprime has implemented MRD into the design of its ongoing Phase II study in AML.
Phase II in AML and high-risk MDS
Next to the ongoing monotherapy study in AML, DCprime has prepared for a multi-center Phase II study based on the combination of DCP-001 and hypomethylating agents (HMA) in high-risk Myelodysplastic syndrome (MDS).
Phase I in Multiple Myeloma (MM)
DCprime completed a robust pre-clinical package in MM and is ready to move this program forward into clinic (Leaf et al., J Immunother. 2017 Nov/Dec;40(9):315-322).
Development in Solid Tumors
Phase I in ovarian cancer
In addition, DCprime has a number of preclinical programs, including in ovarian cancer. DCprime completed a promising pre-clinical data package, presented at SITC 2020 and is currently preparing together with the Nijman group at UMCG a Phase I clinical study in ovarian cancer patients.
The clinical development of DCprime’s therapeutic candidates currently focuses on treating hematological malignancies, such as Acute Myeloid Leukemia (AML) and Myelodysplastic syndrome (MDS). 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.
Multiple Myeloma (MM) also represent a difficult-to-treat oncology indication with high risk of relapse. Current therapies objective is to achieve disease control with acceptable toxicity and patient decent quality of life and transformed MM from an incurable, fatal disease to a manageable, chronic one. We therefore believe, that relapse vaccination can potentially provide an effective treatment by boosting the patients’ immune system to obtain disease control with the advantage to have limited side effects and therefore limited impact on the patient’s quality of life.
DCprime is also investigating the use of its relapse vaccines in solid tumors with a high unmet need, to offer a valuable new treatment approach for patients with few options.
We are currently focusing on ovarian cancers. Despite surgical debulking and chemotherapy, ovarian cancer patients relapse frequently. Approximately 23% of patients relapse during or within 6 months after completion of primary chemotherapy. 60% relapse after 6 months. Unfortunately patients are dramatically lacking therapeutic options in case of relapse.
We therefore believe, that relapse vaccination can potentially provide an effective treatment with limited side effects for ovarian cancer patients and also for other solid tumors.