DCprime to Present Long-term Follow-up and Survival Data for Lead Relapse Vaccine Candidate DCP-001 in High-Risk AML and MDS Patients

Presentation at ASH Annual Meeting Shows Potential to Prolong Relapse-Free Survival and Overall Survival Using an Allogeneic Cell-based Vaccine in the Post-Remission Setting

Leiden, The Netherlands, November 13, 2019DCprime, the front-runner in the field of relapse vaccines, today announced the presentation of updated clinical results for its lead product DCP-001 at the upcoming 61st Annual Meeting and Exposition of the American Society of Hematology (ASH), December 7-10, 2019, Orlando, FL, USA. The long-term follow-up and survival data generated in the Phase 1 clinical trial with DCP-001 in patients with high-risk Acute myeloid leukemia (AML) or Myelodysplastic syndromes (MDS) demonstrate the potential to prolong relapse-free survival (RFS) and overall survival (OS) using an allogeneic, off-the-shelf cell-based vaccine in the post-remission setting. The full abstract is available via the ASH Annual Meeting’s website.

“Our deep dive into the Phase 1 clinical trial results, which we will present in full at the upcoming ASH Annual Meeting, confirms our thinking on when and how our cell-based vaccine DCP-001 can have the greatest impact on patients in the post-remission setting. Treated early and while still in remission, vaccination with DCP-001 can strengthen the immune system’s ability to sustainably control residual disease with one patient surpassing an overall survival of 6 years since inclusion in the trial,” commented Erik Manting PhD, CEO of DCprime.

“The Phase 1 data have evolved since we last updated the clinical community and provide a strong rationale to further investigate the relapse vaccine approach. With the progress made in the clinical community to implement the assessment of minimal residual disease, or MRD, we have designed the currently active Phase 2 clinical trial for DCP-001 to look even more specifically into DCP-001’s ability to support a long-term immune control of the tumour,” commented Jeroen Rovers MD PhD, CMO of DCprime.

In the Phase 1 clinical trial, seven out of twelve patients responded to treatment, the other five patients showed progressive disease. These five patients had relapsed or refractory disease at the start of vaccination with detectable circulating peripheral blasts. Moreover, they were vaccinated after induction and consolidation therapy with a median time between diagnosis and first vaccination of 611 days compared to 240 for the responding patients. Of the latter, all were in complete remission (CR) (n=5) or had morphologic marrow blast counts <10% (n=2) at the start of vaccination.

While the median overall survival (OS) for the non-responders was 144 days, the median OS for the responding patients was 1,090 days, with a longest survivor of 2,160 days after vaccination. The median relapse-free survival in those patients who were in CR at vaccination was 420 days, ranging up to 1,849 days in the longest survivor. Patients in the responding group all had intermediate or high-risk disease, based on cytogenetics, indicating their poor prognosis based on the ELN risk classification for AML or the Revised International Prognostic Scoring System (IPSS-R) for MDS. In the responder group, two patients died early in complete remission due to infection at day 90 and 184, respectively. More details on patient characteristics and cytogenetics will be presented by Dr. Luca Janssen and Prof. Dr. Arjan van de Loosdrecht (PI) at ASH.

DCprime’s lead cancer relapse vaccine candidate DCP-001 is generated by transforming a proprietary leukemic cell, DCOne®, into a whole cell-based cancer vaccine. Whereas the parental leukemic cells are poorly immunogenic, DCP-001 is highly immunogenic, making it an attractive cancer vaccine candidate. DCP-001 is currently being evaluated in an international Phase II trial in AML patients in complete remission and with presence of MRD who are ineligible for hematopoietic stem cell transplantations. First results of the (ADVANCE-II) trial are expected to become available in 2020.

More information on the ongoing Phase 2 is available on https://clinicaltrials.gov.

Abstract number: 1381

Title: Durable Responses and Survival in High-Risk AML and MDS Patients Treated with an Allogeneic Leukemia-Derived Dendritic Cell Vaccine

Presenter: Dr. Janssen

Date: Saturday, December 7, 2019 (5:30 PM – 7:30 PM)

Location: Orange County Convention Center, Hall B

About DCprime
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/

Contact Information:

DCprime BV
Dr. Erik Manting
Phone: +31713322627
Email: e.manting@dcprime.com

Media Contact:
Mario Brkulj or Nicholas Chang
Phone: +49 175 5711562 or +1 781 235 3060
E-Mail: dcprime@macbiocom.com

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