Opening of IND follows approval to study DCP-001 in multiple European countries
Leiden, The Netherlands, May 13, 2020 –DCprime, the front-runner in the field of relapse vaccines, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for DCP-001, an allogeneic cancer relapse vaccine currently being evaluated in a European Phase II trial in Acute Myeloid Leukaemia (AML) patients who are ineligible for hematopoietic stem cell transplantation. The IND provides the possibility for DCprime to expand the ongoing ADVANCE-II trial into the Unites States, where DCP-001 had received orphan drug status in Q4 2019.
“Following encouraging clinical and preclinical data presented at medical conferences in 2019, 2020 should see the first results emerging from the ADVANCE-II study. The possibility to expand our trial activities into the United States is an important step and follows approvals by different European authorities in The Netherlands, Germany, Norway, Sweden, and recently also Finland,” said Jeroen Rovers, MD, PhD, Chief Medical Officer of DCprime. “Although we are currently facing challenging times for clinical studies due to the Covid-19 crisis, DCprime remains committed to expanding its clinical network to support the development of relapse vaccines in AML and other cancer types. Securing the regulatory approval now, allows us to move quickly once the current clinical situation around Covid-19 improves.”
The currently active international, multi-center, open-label proof-of-concept study ADVANCE-II is recruiting AML patients in complete remission, but with persistent measurable residual disease (MRD), which is associated with a high relapse rate. The effect of DCP-001 on MRD in combination with immunomonitoring will be used to evaluate the efficacy of DCprime’s relapse vaccination strategy.
Clinical data from a previously concluded Phase I clinical study that was presented at the 61st Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2019 demonstrated DCP-001’s potential to prolong relapse-free survival and overall survival in the post-remission setting.
For more information on the clinical trial, please visit: www.clinicaltrials.gov
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 DCP-001 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
Mario Brkulj or Nicholas Chang
Phone: +49 175 5711562 or +1 781 235 3060