Cancer Peptide Vaccine Designated Orphan Drug for MDS
Boston Biomedical announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational cancer peptide vaccine to treat myelodysplastic syndrome (MDS).
The DSP-7888 vaccine contains peptides to induce Wilms' tumor gene 1 (WT-1)-specific cytotoxic T lymphocytes (CTL) and helper T cells that attack WT1-expressing malignant cells. It is currently being evaluated as monotherapy in a Phase 1/2 study in MDS patients, a Phase 1/2 study in pediatric patients with relapsed or refractory high-grade gliomas, and a Phase 1 study in advanced malignancies.
Data from a Phase 1/2 study in patients with MDS who had disease progression on or after first-line azacitidine treatment showed initial signs of clinical activity with DSP-7888, and that it was well tolerated in study patients.
DSP-7888 will be studied in combination with bevacizumab in a Phase 2 study in patients with recurrent or progressive glioblastoma.
For more information visit BostonBiomedical.com.