Phase II Data for DCprime’s Cell-based Cancer Relapse Vaccine Shows the Potential to Successfully Control Residual Disease as the Basis for a Prolonged Remission in AML
Leiden, The Netherlands, December 7, 2020 – DCprime, the front-runner in the field of relapse vaccines, published interim results from its ongoing Phase II study (ADVANCE II, Clintrials.gov: NCT03697707) in an oral presentation at the virtual 62nd ASH Annual Meeting and Exposition on December 5, 2020. The data presented at ASH by Prof. dr. Arjan van de Loosdrecht from the Amsterdam University Medical Center highlight the potential of the company’s lead vaccine candidate, DCP-001, to improve the treatment options for patients with Acute Myeloid Leukemia (AML) in the post-remission setting. Interim data on the primary endpoint from this ongoing study indicates that vaccination with DCP-001 is well-tolerated and is able to generate a tumor-specific immune response potentially leading to long-lasting tumor control. The study continues to enroll patients at the higher of the two vaccine doses tested and top-line results are expected to be available end of 2021.
“Persistence of measurable residual disease, or MRD, in patients with acute myeloid leukemia equates to a poor prognosis for patients and represents a significant unmet medical need. The prerequisite for lasting tumor control and prolonged remission is not only to convert patients with minimal residual disease to an MRD-negative state but also to stabilize it. The interim results and case studies we presented at ASH indicate that our relapse cancer vaccination strategy can achieve this goal by inducing a tumor-specific immune response and transforming the prognosis for long-term survival in AML,” commented Erik Manting, PhD, CEO of DCprime.
“Although early stage, the interim data we presented at ASH provide a promising snapshot at the full therapeutic potential of our approach. Provided with the right tools, the possibility to prolong remission for a number of patients has wider medical implications and could be transformative for future cancer care. The study results will continue to mature over the course of 2021 as we are progressing to treat patients in the higher dose group and aim to have top-line data available in Q4 2021,” commented Jeroen Rovers, PhD, CMO of DCprime.
“The interim results of the study reaffirm that the usage of this novel relapse vaccine is very safe and easy to use in patients. Initial data on immunological responses seem to indicate that it triggers an immune response, which is also seen in patients through local redness and swelling at the injection site. It is very promising to see that in the small set of patients treated to date we already observed two cases of MRD conversion, making these patients MRD-negative and thus providing hope for durable disease control,” commented Prof. Dr. Arjan van de Loosdrecht, Department of Hematology, Vumc, and Principal Investigator of the ADVANCE-II study.
The ongoing ADVANCE II clinical trial aims to enroll up to 20 AML patients, ineligible for hematopoietic stem-cell transplantation (HSCT), who are in first complete remission (CR1) but who have confirmed measurable residual disease (MRD+). MRD is assessed in the bone marrow through flow cytometry and/or qPCR. Patients receive a primary vaccination regimen of 4 times 25×106 or 50×106 cells per vaccination, biweekly, followed by two booster vaccinations at week 14 and 18 after start of treatment. Primary endpoints of this trial are the safety and tolerability of the two vaccine doses, the induced immune response, and the effect of vaccination on the MRD status. Additionally, cellular and humoral immune response induced by DCP-001 against known tumor-associated antigens such as WT-1, RHAMM, and PRAME are evaluated in peripheral blood using several assay methods.
ADVANCE II interim efficacy and safety results
Fifteen patients (median age 61, range 40-76) have been enrolled and dosed within the study, completing the first dose cohort of 10 patients at 25×106 cells per vaccination and treating first patients at the 50×106 cells per vaccination dose. All vaccinations were well tolerated and adverse events to the vaccine were transient and limited to local injection site reactions such as redness, swelling, and warmth (maximum grade 2) as observed with most vaccines. Seven patients were evaluated for their MRD status with two patients turning MRD-negative at the first time point after the initial vaccinations (week 14) and remained MRD-negative until the end of active follow-up (week 32). Five other patients remained in complete remission up to week 32, but with detectable MRD. Three patients had early disease progression before the vaccination schedule was completed and before MRD could be assessed. The remaining five patients had not yet completed the vaccination schedule and not yet reached the first MRD assessment, but they remained in CR up to the reporting date.
The data presented at ASH included the evaluation of the immune response before, during, and after DCP-001 vaccination had been performed in a subset of five patients including both of the patients who converted from MRD+ at trial entry to MRD-negative status after vaccination. In these patients, increases in tumor-specific functional T-cells were observed, with induced responses against the tumor-associated antigens WT-1, RHAMM, and PRAME based on IFNy ELISPOT. These antigens represent some of the tumor-associated antigens (TAA’s) known to be expressed by DCP-001. Using flow cytometry, increases in levels of CD8+/CD137+ cells (primed T-cells) are observed in almost all patients, already at 2 days post-vaccination.
The ADVANCE II study is driven by the AML-VACCiN consortium (https://www.amlvaccin.eu) and received funding by the European Union under the EU Horizon 2020 project (https://cordis.europa.eu/project/id/667713).
On November 18, 2020, it was announced that Immunicum AB and DCprime aim to combine forces to establish a leader in cell-based cancer immunotherapies. For further information please visit: https://immunicum.se/proposed-transaction/
DCprime is the front-runner in the field of relapse vaccines, a new class of oncology vaccines administered after or in conjunction with standard of care therapy to delay or prevent disease recurrence. Our lead product is a whole-cell-based vaccine addressing blood cancers with a high risk of relapse. We are pursuing similar vaccination approaches for solid tumors. We believe relapse vaccines will improve survival by putting the patient’s immune system back in control. For more information, please visit: https://dcprime.com/
Dr. Erik Manting, CEO
Phone: +31 713322627
Mario Brkulj or Nicholas Chang
Phone: +49 175 5711562 or +1 781 235 3060