The U.S. Food and Drug Administration (FDA) has expanded orphan drug designation for SurVaxM, a brain cancer immunotherapy born in the labs of Roswell Park Comprehensive Cancer Center.
The supplemental designation awarded to MimiVax Inc. now applies to SurVaxM as treatment for not just adult glioblastoma but a broader category of cancerous brain tumors: any malignant glioma in children or adults. Orphan status is a designation awarded by the FDA to encourage research and development of drugs that have shown promise in treating, preventing or diagnosing rare diseases.
SurVaxM is a synthetic cancer vaccine that stimulates the immune system to attack tumor cells that carry a protein called survivin. MimiVax first received orphan drug status for SurVaxM in August 2017, for treatment of adult glioblastoma. The supplemental designation greatly expands the potential for SurVaxM's use in other forms of pediatric and adult malignant gliomas.
Gliomas are the most common type of cancer originating in the brain. Receiving orphan drug designations for SurVaxM emphasizes the critical demand for novel and enhanced therapeutic options for people living with malignant gliomas. We hope that this designation may help to advance SurVaxM's application for important indications beyond adult glioblastoma, including for pediatric brain cancers.
" Michael Ciesielski, PhD, Assistant Professor of Neurosurgery at Roswell Park and CEO of MimiVax SurVaxM was invented at Roswell Park by Dr. Ciesielski and R.
