Earlier today, it was announced by Boston Biomedical, Inc. that its investigational cancer peptide vaccine, DSP-7888, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS).
DSP-7888 is currently being studied in various phase 1/2 clinical trials, and contains peptides to induce Wilms’ tumor gene (WT1)-specific cytoxic T lymphocytes (CTL) and helper T cells, both of which attack WT1-espressing cancerous cells in an array of hematologic and solid cancer types.
It is hypothesized that the addition of helper T cell-inducing peptides will be more efficacious compared to using a killer peptide treatment regimen on its own.
MDS, a group of rare blood disorders characterized by irregular development of blood cells within the bone marrow, affects an estimated 10-15,000 new patients in the United States annually. Per the American Cancer Society
, 1/3 of all MDS patients eventually develop acute myeloid leukemia (AML), a quickly-progressing growth of cancer of bone marrow cells.
"Receiving an Orphan Drug Designation for DSP-7888 reinforces our dedication to helping address an unmet medical need for people with myelodysplastic syndrome, where other therapies are still needed," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. via press release
"We are committed to uncovering the potential therapeutic benefit of cancer peptide vaccines, and we look forward to advancing the clinical development of this first-in-class compound."
Boston Biomedical’s compound is currently being investigated in 3 monotherapy studies:
Phase 1/2 study in MDS (NCT02436252)
Phase 1/2 study in pediatric patients with relapsed or refractory high grade gliomas (NCT02750891)
Phase 1 study in advanced malignancies (NCT02498665).
DSP-7888 will also be evaluated in combination with bevacizumab in a phase 2 study that is currently recruiting patients with recurrent or progressive glioblastoma (NCT03149003
More information on DSP-7888 and ongoing clinical trials can be found at BostonBiomedical.com
. More updates on orphan drug designations can be found by following Rare Disease Report