The 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 applies
to SurVaxM as treatment for not just adult glioblastoma but any
malignant glioma in children or adults.
BUFFALO,
N.Y., June 21, 2024 /PRNewswire-PRWeb/ -- 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.
"SurVaxM is one of the few treatment
options for incurable brain cancer to reach late-stage clinical
trials, and everyone who supports this work is helping to speed a
highly promising cancer treatment to patients who may benefit from
it." – Candace S. Johnson, PhD,
President & CEO, Roswell Park
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," says Michael Ciesielski, PhD, Assistant Professor of
Neurosurgery 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 pediatric
brain cancers."
SurVaxM was invented at Roswell Park by Dr. Ciesielski and
Robert Fenstermaker, MD, Roswell
Park Chair of Neurosurgery. "We are greatly encouraged by the new
enhanced designation as we begin to explore SurVaxM's potential
effectiveness against brain cancers other than glioblastoma," says
Dr. Fenstermaker, who is also Professor of Neurosurgery and
Oncology and Director of Neuro-Oncology at Roswell Park.
Work to develop the vaccine has been enabled by donations from
numerous individuals and corporations to the Roswell Park Alliance
Foundation, including support from events like the Ride for
Roswell, which will see thousands of cyclists riding routes
throughout Western New York and
into Canada on June 22.
"Roswell Park and all of Western New
York have so much reason to be proud of SurVaxM and the team
behind it," says Roswell Park President and CEO Candace S. Johnson, PhD. "SurVaxM is one of the
few treatment options for incurable brain cancer to reach
late-stage clinical trials, and everyone who supports this work is
helping to speed a highly promising cancer treatment to patients
who may benefit from it."
Last fall, the FDA awarded MimiVax and SurVaxM Fast Track
Designation (FTD), a distinction that facilitates the development
and review of drugs to treat serious medical conditions and fulfil
unmet need. Results from the fully accrued phase 2b SURVIVE trial (NCT05163080) of SurVaxM in
patients with newly diagnosed glioblastoma at 11 cancer centers
nationwide are expected as early as next year, and a pilot study of
the vaccine in children and adolescents with several forms of brain
cancer is underway. SurVaxM is also being studied as a treatment
for neuroendocrine tumors and multiple myeloma in adults.
MimiVax was formed more than a decade ago as a spinoff from
Roswell Park to develop and commercialize SurVaxM.
Media Contact
Annie Deck-Miller, Roswell Park
Comprehensive Cancer Center, 716-845-8593,
annie.deck-miller@roswellpark.org, roswellpark.org
View original content to download
multimedia:https://www.prweb.com/releases/fda-expands-orphan-drug-designation-for-survaxm-immunotherapy-developed-at-roswell-park-302179399.html
SOURCE Roswell Park Comprehensive Cancer Center