FDA Awards Orphan Status to SurVaxM, Brain Cancer Vaccine Developed at Roswell Park Cancer Institute

Drs. Robert Fenstermaker and Michael Ciesielski of Roswell Park Cancer Institute, co-inventors of the SurVaxM vaccine.

Those of us working to help patients with glioblastoma to live longer realize that the gains from existing therapies have been quite limited.

The U.S. Food and Drug Administration has awarded orphan drug status to a promising immunotherapy vaccine developed at Roswell Park Cancer Institute. The FDA notified MimiVax LLC, a Roswell Park spinoff company, on Aug. 3 that its application for orphan status for SurVaxM as treatment for glioblastoma, a type of brain cancer, had been approved.

Orphan status is a special designation awarded to encourage innovation and exploration of approaches to treat rare diseases that affect relatively few people. SurVaxM, also known as DRU-2017-5947, is an immunotherapy drug that targets survivin, a cell-survival protein present in most cancers.

Invented by two Roswell Park faculty members, the vaccine stimulates the immune system to kill tumor cells that contain survivin, a protein that helps cancer cells to resist conventional treatments. A phase II study of SurVaxM given in addition to standard treatment for patients with newly diagnosed glioblastoma is ongoing at Roswell Park and four other institutions: the Cleveland Clinic, Dana-Farber Cancer Institute, Massachusetts General Hospital and Beth Israel Deaconess Medical Center.

“We are excited by the results to date and appreciative of this acknowledgement that SurVaxM holds promise,” says SurVaxM co-inventor Robert Fenstermaker, MD, Chair of Neurosurgery at Roswell Park and Chief Medical Officer at MimiVax. “Those of us working to help patients with glioblastoma to live longer realize that the gains from existing therapies have been quite limited. We are eager to move this work forward to a larger multicenter randomized study with the momentum provided by the orphan status designation.”

The vaccine is designed to control tumor growth and recurrence.

“There are a couple of things that distinguish our approach,” adds co-inventor Michael Ciesielski, PhD, Assistant Professor of Neurosurgery at Roswell Park and Chief Scientific Officer for MimiVax. “SurVaxM is an engineered molecule capable of…

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