FDA Grants Ovarian Cancer Vaccine Orphan Drug Designation
TapImmune announced that the Food & Drug Administration (FDA) has granted Orphan Drug designation to its cancer vaccine, TPIV 200, in the treatment of ovarian cancer.
TPIV 200 demonstrated its safety and tolerability in a Phase 1 clinical trial conducted in patients with breast and ovarian cancer. In addition, the vaccine was shown to provide strong immune response in 20 out of 21 subjects, with prolonged immune responses shown in 100% of patients during the observational stage (n=16). TapImmune intends to evaluate TPIV 200 in multiple Phase 2 studies to examine its efficacy in ovarian and triple negative breast cancer patients.
Currently, no FDA approved cancer vaccine is available for ovarian cancer. Treatment options include surgery, radiation, and chemotherapy.
TPIV 200 is a multi-epitope peptide vaccine targeting Folate Receptor Alpha.
For more information visit TapImmune.com.