Leiden, The Netherlands, December 05, 2019 –DCprime, the front-runner in the field of relapse vaccines, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to DCP-001 for the treatment of acute myeloid leukemia (AML). DCP-001 is a cell-based vaccine addressing blood cancers with a high risk of relapse and is currently being evaluated in a Phase II clinical trial in AML.
“Receiving orphan drug designation for AML marks an important regulatory milestone in our development for DCP-001,” said Jeroen Rovers, MD, PhD, Chief Medical Officer of DCprime. “We look forward to sharing results from our Phase II AML trial next year and continuing to advance DCP-001 for this devastating disease.”
In clinical data that will be presented at the upcoming 61st Annual Meeting and Exposition of the American Society of Hematology (ASH), DCP-001 demonstrates the potential to prolong relapse-free survival and overall survival as an allogeneic, off-the-shelf cell-based vaccine in the post-remission setting. DCP-001 is currently being evaluated in an international Phase II trial in up to 20 AML patients in complete remission and with presence of minimal residual disease (MRD) who are ineligible for hematopoietic stem cell transplantations. First results of the (ADVANCE-II) trial are expected to become available in 2020.
Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to therapies designed to treat rare diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation entitles recipients to various development incentives, including tax credits for qualified clinical testing, an exemption from FDA application fees, and a seven-year period of marketing exclusivity in the United States, if the drug is approved.
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
Mario Brkulj or Nicholas Chang
Phone: +49 175 5711562 or +1 781 235 3060