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The US Food and Drug Administration (FDA) has granted an expanded Orphan Drug Designation (ODD) for brain cancer immunotherapy SurVaxM, originally created at Roswell Park Comprehensive Cancer Center.

SurVaxM is a synthetic cancer vaccine that stimulates the immune system to attack tumour cells that carry the survivin protein, first received as an ODD though MimiVax, a spin-off of Roswell Park, in 2017, for the treatment of adult glioblastoma. This supplementa l designation will expand its potential in other forms of both paediatric and adult malignant gliomas.

The immunotherapy is currently being assessed in the phase 2b SURVIVE trial in patients with newly diagnosed glioblastoma at 11 cancer centres nationwide, with a separate pilot study of the vaccine being undertaken in children and adolescents with several forms of brain cancer.

“Roswell Park and all of Western New York have so much reason to be proud of SurVaxM and the team behind it,” said Candace S Johnson PhD, Roswell Park president and CEO. “SurVaxM is one of the few treatment options for incurable brain cancer to reach late-stage clinical trials, and ever yone who supports this work is helping to speed a highly promising cancer treatment to patients who may benef it from it.”

“Receiving orphan drug designations for SurVaxM emphasises the critical demand for novel and enhanced therapeutic options for people living with malignant gliomas,” added Michael Ciesielski PhD, assistant professor of Neurosurger y at Roswell Park and CEO of MimiVax. “We hope that this designation may help to advance SurVaxM’s application for important indications beyond adult glioblastoma, including for paediatric brain cancers.”