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news.The US Food and Drug Administration (FDA) has granted orphan drug status for Immunovaccine's clinical-stage cancer immunotherapy, DPX-Survivac, for the treatment of ovarian cancer.
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The company noted that this orphan designation is valid for all applications of DPX-Survivac in ovarian cancer without restriction to a specific stage of disease.
DPX-Survivac activates and directs an immune response to the tumor antigen survivin, a protein that is found in tumors of more than 90% of ovarian cancer patients.
The orphan drug status was granted following a review by the FDA of pre-clinical and clinical data submitted by the company.
The data from a Phase I trial in advanced ovarian cancer showed strong and durable immune responses in the majority of patients receiving DPX-Survivac in combination with low dose oral cyclophosphamide.
Immunovaccine chief executive officer Marc Mansour said: "Receiving Orphan Drug Designation for ovarian cancer underlines the fact that DPX-Survivac may address a significant unmet medical need for this important disease.
"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".
DPX-Survivac includes survivin-based peptide antigens formulated in the DepoVax adjuvanting platform.
The National Cancer Institute (NCI) has recognized Survivin as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity.