Immunotherapy invented at Roswell Park is fast tracked by the FDA
In the spring of 2023, Cassandra Johnston and her husband Nolan Wolf were thrilled to welcome their newborn, Michael, to the world. He came about five weeks early, surprising everyone, but now Cassandra looks back and says her body must have known it was time. Just three weeks later, a more sinister surprise came to light. Cassandra was diagnosed with glioblastoma, an aggressive form of brain cancer.
Surgery came quickly to remove as much of the tumor as possible. Then came radiation and oral chemotherapy at nearby Princess Margaret Cancer Centre; an easy choice for the Toronto-based family with close ties to the hospital. Cassandra’s mom, Christine, had worked there for 13 years before retiring, so the family knew the high-quality, research-based care they would receive there. And they were familiar with cancer — glioblastoma is notoriously hard to treat.
Cassandra, Nolan and Nolan's 9-year-old daughter Kyla had been waiting and hoping for their sweet Michael for three years. Now, cancer threatened to rip Cassandra away from her family. They needed options; they needed hope. That’s when they came to Roswell Park Comprehensive Cancer Center.
Christine was busy looking into clinical trials and other novel options for her daughter when a friend in Florida sent her a national news story. There was a cancer center in Buffalo, New York, that had developed an immunotherapy, called SurVaxM, that was available through a clinical trial. SurVaxM is a treatment vaccine for patients with glioblastoma which may help to slow or stop the growth of the cancer.
Finally, some good news: thanks to international collaboration between the two centers, Cassandra learned she was eligible for this clinical trial at Roswell Park. Though it comes with long days and a drive across the border, Cassandra enrolled in the trial.
Brain cancer vaccine granted fast track status by FDA
In October 2023, a major announcement from the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) for SurVaxM, which opens up doors for more extensive and accelerated access to FDA resources to continue to develop SurVaxM.
SurVaxM was created in a lab at Roswell Park by Robert Fenstermaker, MD, Chair of Neurosurgery and Michael Ciesielski, PhD, Assistant Professor of Neurosurgery. Dr. Fenstermaker is the Principal Investigator of the nationwide randomized trial and Dr. Ciesielski is CEO of MimiVax, the company which now produces SurVaxM. Their work has been passionately supported by donor funding for the past 10 years, proving instrumental in bringing this new treatment to where it is today. “Fast Track Designation is a key component in our journey to help patients with glioblastoma to live longer,” said Dr. Ciesielski.
Current trial reaches across the nation
The vaccine is currently in a phase 2b clinical trial, with an anticipated 270 patients across 11 cancer centers across the country. Because this is a randomized, blind trial, some patients will receive the vaccine, and some will receive a placebo in order to collect the best possible data to move the trial forward. A successful phase 2a trial demonstrated that 51% of patients receiving SurVaxM survived at least 2 years, and 41% survived at least 3 years — considerably longer than the expected outcomes from standard therapy alone.
“Glioblastoma remains one of those cancers that’s extremely difficult to treat, and treatments have improved only modestly in the last few decades,” Dr. Fenstermaker said. “There’s a real need for better treatments for patients with this disease, and thanks to the support of our colleagues and community we are grateful to see our work with SurVaxM advance to this exciting stage.”
SurVaxM: Immunotherapy for glioblastoma
Find out more about this one-of-a-kind clinical trial designed to fight newly diagnosed glioblastoma.
“We need more breakthroughs in cancer,” Christine says. “It takes patients like Cassandra to try new therapies and get the evidence to bring them up to the population. And without research you’re not going to find more effective therapies. We thank donors for hanging in there and funding the doctors and this research. They couldn’t do it without donors. There’s a lot to be grateful for even in the face of this diagnosis.”
Cancer research at Roswell Park is fueled by donations to the Roswell Park Alliance Foundation. SurVaxM is just one of many initiatives backed by the Roswell Park community. Our generous donors support everything from research seed funding to clinical trials to patient care programs to facility expansions.
Editor’s Note: Cancer patient outcomes and experiences may vary, even for those with the same type of cancer. An individual patient’s story should not be used as a prediction of how another patient will respond to treatment. Roswell Park is transparent about the survival rates of our patients as compared to national standards, and provides this information, when available, within the cancer type sections of this website.
