Boston Biomedical has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DSP-7888, a vaccine for the treatment of patients with brain cancer.
Today’s announcement marks the second orphan drug designation of 2017 for the investigational cancer peptide vaccine. The first came in June when the therapy was recognized for the treatment of myelodysplastic syndrome
While brain tumors aren’t known to spread to other parts of the body, many spread throughout the brain tissue, and even benign tumors can cause permanent and sometimes fatal damage. The American Cancer Society
estimates that more than 23,000 malignant brain or spinal cord tumors will be diagnosed in the US in 2017, resulting in almost 17,000 deaths.
The peptides that make up DSP-7888 vaccine are intended to induce Wilms’ tumor gene 1 (WT1)-specific cytotoxic T lymphocytes and helper T cells, which attack WT1-expressing cancerous cells found in many types of hematologic and solid cancers. The National Cancer Institute
has previously ranked WT1 as the top priority target for cancer immunotherapy.
"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. in a press release
The potential therapy is currently being evaluated in several phase 1 and phase 2 studies, including:
- A phase 1/2 study in myelodysplastic syndrome (NCT2436252)
- A phase 1/2 study in pediatric patients with relapsed or refractory high grade gliomas (NCT02750891)
- A phase 1 study in advanced malignancies (NCT02498665)
Additionally, the drug is being evaluated in combination with bevacizumab in a phase 2 study in patients with recurrent or progressive glioblastoma (NCT03149003
). It is anticipated that by adding helper T-cell peptides to the killer peptide treatment alone, improved efficacy may be achieved.
"We are dedicated to developing novel treatments for patients with high unmet need malignancies and look forward to further study of this candidate," said Andrews.
For more from the FDA, including applications, designations and approvals, follow RDR