Glioblastoma Vaccine Granted Orphan Drug Status

Orphan drug status has been issued by the U.S. Food and Drug Administration (FDA) for SurVaxM, an immunotherapy (vaccine) treatment for glioblastoma, which is a deadly type of brain cancer.

Orphan status is a special designation awarded by the FDA to encourage the discovery of innovative treatments for rare diseases that affect relatively few people.

SurVaxM, also known as DRU-2017-5947, stimulates the immune system to kill tumor cells that contain survivin, a protein that helps cancer cells to resist conventional treatments.

This vaccine is designed to control tumor growth and recurrence.

Co-inventor Michael Ciesielski, PhD, Assistant Professor of Neurosurgery at Roswell Park and Chief Scientific Officer for MimiVax said “SurVaxM is an engineered molecule capable of stimulating the immune system in several different ways to recognize and kill cancer cells. And the fact that its target, survivin, is present in many different types of cancer suggests potentially broad application against cancer.”

Glioblastoma is the most common form of brain cancer in adults, with approximately 14,000 cases of the disease diagnosed each year in the United States.

Glioblastoma is an aggressive type of cancer that can occur in the brain or spinal cord. Glioblastoma forms from cells called astrocytes that support nerve cells. Glioblastoma can occur at any age, but tends to occur more often in older adults. It can cause worsening headaches, nausea, vomiting and seizures.

Glioblastoma multiforme (GBM) is the most common adult primary malignant brain tumor. Ninety percent of adult GBM patients die within 24 months after diagnosis.

The Alliance Foundation raises funds in support the current clinical study of SurVaxM in patients with newly diagnosed glioblastoma. Additional details are available.

MimiVax LLC, is a clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutic vaccines and targeted therapies for cancer treatment.