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. 

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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.

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