In the fall of 2020, John Wishman was diagnosed with glioblastoma, the deadliest form of brain cancer. Two-and-a-half years later, he’s still traveling and enjoying life, a rarity in cancer, which has an average survival rate of just 12 to 18 months.
Wishman, 61, of Buffalo, New York, attributes it to an experimental vaccine designed to slow tumor progression. The vaccine, called SurVaxM, targets a protein in tumors called survivin, named for the role it is thought to play in cancer cell survival. Get rid of survivin, the thinking goes, and the cancer cells will die.
It sounds like a distant dream: a vaccine that could delay the return of glioblastoma, one of the deadliest and most treatment-resistant cancers. According to Tom Halkin, a spokesman for the National Brain Tumor Society, a nonprofit organization, more than 14,000 people were diagnosed in the U.S. last year. It accounts for almost half of all malignant brain tumors. The disease is devastating to patients and families; the five-year survival rate is 6.8%.
Wishman obtained the vaccine through the expanded access program (sometimes called charitable use), which allows seriously ill patients to receive experimental drugs. His daughter, Lydia, is a nurse at Roswell Park Comprehensive Cancer Center, where researchers are studying the drug.
In an early clinical trial, SurVaxM was found to increase the survival time of people diagnosed with brain cancer by an average of 26 months. Now the drug’s maker, New York-based MimiVax, is enrolling patients in a larger study in hopes of confirming the results. The Advanced Access program is no longer available.
The new study will enroll up to 270 patients. It is expected to take place at more than 10 sites in the US and China and will be compared with patients receiving standard care.
65-year-old Tracey Kassman signed up in April 2022, three months after she was diagnosed with glioblastoma. She got her first shot that same month.
Kassman, a retired attorney from Buffalo, is now shot once every two months. But because the trial is randomized and double-blind, neither Kassman nor her doctors know whether she’s getting the vaccine or a placebo.
“Sometimes it was a leap of faith,” she said, “because right before the shooting, I had this MRI, and every time I get an MRI, I’m like, ‘Okay, this could be it.’ ‘”
Why is glioblastoma so difficult to treat?
Glioblastomas are aggressive cancers; they grow quickly and have usually invaded other parts of the brain and spinal cord by the time a person is diagnosed.
Surgical removal of the entire tumor is almost impossible.
“It’s like octopus tentacles reaching out to other parts of the brain,” said Honggang Cui, an assistant professor of chemical and biomolecular engineering at the Johns Hopkins Whiting School of Engineering.
Treatment usually includes surgery, chemotherapy, and radiation, Cui said. But unless every cancer cell is removed, the tumor often comes back in a process called recurrence.
SurVaxM trains the immune system to target and attack cancer cells, so if they return, the body can eliminate them without allowing a new tumor to grow, said MimiVax CEO Michael Ciesielski.
The approach is “very promising,” Cui said. “This could give hope to people affected by GBM.”
Study participants will first undergo surgery to remove as much of the tumor as possible, followed by radiation and chemotherapy with a drug called temozolomide, said Dr. Robert Fenstermaker, chief of neurosurgery at Roswell Park Comprehensive Cancer Center. Developer of SurVaxM.
“There’s usually about a month off while the radiation is still working, and that’s the phase we like to start vaccinations in because that’s when the immune system is rejuvenating,” he said.
The vaccine, which is injected into the arm, like the flu shot or the COVID vaccine, consists of four doses spread over two months, followed by booster shots every two months. Trial participants will receive either the real vaccine or a placebo each time. Participants will also receive brain scans every two months to monitor for signs of progression.
The need for different perspectives
SurVaxM is not the first attempt to develop a vaccine to delay the recurrence of glioblastoma. According to Ciesielski, other cancer vaccines have been targeted at survivin, but none have so far reached mid- to late-stage clinical trials.
Dr. Alyx Porter, a neuro-oncologist at the Mayo Clinic in Phoenix, said the approach is different from what has been tried in the past.
For example, targeted therapies such as checkpoint inhibitors have gained popularity in recent years and have improved survival rates for people with cancer, including breast or lung cancer. However, these drugs are much less effective for brain tumors because they cannot cross the blood-brain barrier, a network of blood vessels that prevents foreign substances from entering the brain.
Porter believes that the antibodies created by the vaccine will be able to reach the brain. But she added that “the proof will be the pudding with the trial.”
Results are still a long way off. According to Ciesielski, the company doesn’t expect results from the Phase 2b trial until 2024 at the earliest. mid, and the trial likely won’t be completed for another 18–24 months after that. If successful, the company will need to conduct a larger Phase 3 clinical trial.
The high death rate from glioblastoma “ensures that people are pushing forward and looking for new treatments, which allows us to really maximize the benefits of immunotherapy,” said Porter, who is not involved in the SurVaxM study.
So far, the drug appears safe, Fenstermaker said. Known side effects of the vaccine include fever, itching, redness, and muscle aches.
Ciesielski said the company also plans to use the vaccine for other cancers, including multiple myeloma and neuroendocrine tumors, a rare form of cancer that can develop anywhere there are neuroendocrine cells that are found in various organs, including the lungs, pancreas, and gastrointestinal tract.
Kassman, of Buffalo, New York, feels “incredibly lucky” to have access to treatment.
“I could have ignored this whole thing for a couple of weeks,” she said, “and I might not be here to talk to you about it.
Follow up on NBC Health-enabled Twitter and Facebook.
This article was originally published on NBCNews.com
#experimental #vaccine #shows #promise #slowing #return #aggressive #brain #tumor