The FDA has granted Orphan Drug Designation to the immunotherapy DPX-Survivac, which is in development for the treatment of ovarian cancer.
The US Food and Drug Administration (FDA) granted Orphan Drug Designation to an immunotherapy known as DPX-Survivac, which is in development for the treatment of ovarian cancer. The drug has produced some positive phase I results and is also being tested in recurrent diffuse large B-cell lymphoma.
“Receiving Orphan Drug Designation for ovarian cancer underlines the fact that DPX-Survivac may address a significant unmet medical need for this important disease,” said Marc Mansour, the CEO of the drug’s developer, Immunovaccine, in a press release. “Immunotherapy could change the way we treat all cancers in the future, and we plan to continue to study of DPX-Survivac for the treatment of ovarian cancer as well as other solid tumor types and blood cancers.”
The immunotherapy targets the tumor antigen survivin, which the company says is found in more than 90% of ovarian tumors. The orphan drug designation follows an earlier fast track designation for DPX-Survivac, specifically for patients with advanced ovarian, fallopian tube, or peritoneal cancer with no measurable disease following initial surgery and front-line therapy.
The FDA’s new move follows the publication of results from a small phase I trial in OncoImmunology in May of this year. DPX-Survivac was tested in combination with the immune-modulator metronomic cyclophosphamide in 19 patients with ovarian cancer. They found that the therapy induced survivin-specific immune responses in all patients, and that higher dose of the vaccine and cyclophosphamide generated responses of higher magnitude.
“The level of immune activation observed both quantitatively and qualitatively is unprecedented in a cancer population,” wrote study authors led by Neil L. Berinstein, MD, of Sunnybrook Health Sciences Centre in Toronto. “This vaccine combination may be an ideal candidate for further combination with other promising immunotherapeutics such as checkpoint inhibitors.”
Though the trial was not powered for observation of clinical activity, the authors noted that after 6 months, 12 of 18 patients remained without clinical progression. Further follow-up is ongoing.
According to ClinicalTrials.gov, DPX-Survivac is being tested in ovarian, fallopian, and peritoneal cancer, as well as in a phase II study of patients with recurrent diffuse large B-cell lymphoma. That trial also uses the immunotherapy in combination with cyclophosphamide.