The FDA has granted an orphan drug designation for DSP-7888 (Boston Biomedical, Inc.), an investigational cancer peptide vaccine, for the treatment of brain cancer. This is the second orphan drug designation 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. Boston Biomedical is also 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.
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 orphan drug designation program provides special status and development incentives for drugs and biologics that 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.
Source: Boston Biomedical; October 10, 2017.