Boston Biomedical announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for DSP-7888, an investigational cancer peptide vaccine, for the treatment of brain cancer. This is the second ODD for DSP-7888 this year. The first was granted in June 2017 for myelodysplastic syndrome.
DSP-7888 contains peptides to induce Wilms’ tumor gene 1 (WT1)-specific cytotoxic T lymphocytes and helper T cells, which attack WT1-expressing cancerous cells found in various types of hematologic and solid cancers. The National Cancer Institute ranked WT1 as the number one priority target for cancer immunotherapy. We are evaluating DSP-7888 in phase 1 and 2 studies for patients with pediatric high grade gliomas, myelodysplastic syndrome, recurrent or progressive glioblastoma, and other malignant cancers.
“We are pleased to receive the second orphan drug designation for DSP-7888 this year, which strengthens our belief in this innovative cancer therapy and its potential to provide a meaningful treatment advancement for people with brain cancer who often face a poor prognosis,” said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. “We are dedicated to developing novel treatments for patients with high unmet need malignancies and look forward to further study of this candidate.”
It is estimated that approximately 23,800 malignant brain or spinal cord tumors will be diagnosed this year in the U.S., leading to 16,700 deaths. The FDA’s ODD program provides special status and development incentives for drugs and biologics which are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S.