Doctor checking MRI scan on the lookout for brain tumor or stroke in patient.
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John Wishman was diagnosed with the deadliest type of brain cancer, glioblastoma, in fall 2020.
Two and a half years later, he’s still traveling and having fun with life — a rarity for a cancer with a mean survival time of just 12 to 18 months.
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Wishman, 61, of Buffalo, Latest York, attributes that to an experimental vaccine that is designed to delay the progression of the tumor. The vaccine, called SurVaxM, targets a protein present in tumors called survivin, named for the role it’s thought to play within the survival of cancer cells. Eliminate survivin, the considering goes, and the cancer cells will die.
It feels like a far-fetched dream: a vaccine that may delay the return of glioblastoma, one among the deadliest and treatment-resistant cancers. Greater than 14,000 people within the U.S. were diagnosed last 12 months, based on Tom Halkin, a spokesperson for the National Brain Tumor Society, a nonprofit group. It accounts for nearly half of all malignant brain tumors. The disease is devastating for patients and families; the five-year survival rate is 6.8%.
Wishman got the vaccine through an expanded access program — sometimes called compassionate use — that enables seriously unwell patients to realize access to experimental medicines. 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 survival time for people diagnosed with the brain cancer to 26 months, on average. Now the drugmaker, Latest York-based MimiVax, is enrolling patients in a bigger trial, hoping to substantiate the outcomes. The expanded access program is not any longer available.
The brand new trial will enroll as much as 270 patients. It is predicted to happen at greater than 10 sites within the U.S. and China and can compare the shot to patients who receive standard care.
Tracey Kassman, 65, enrolled in April 2022, three months after being diagnosed with glioblastoma. That very same month, she received her first shot.
Kassman, a retired lawyer from Buffalo, now gets a shot once every two months. But since the trial is randomized and double-blinded, neither Kassman nor her doctors know if she’s getting the vaccine or a placebo.
“It has been at times a leap of religion,” she said, “because right before I get the shot, I even have this MRI, and each time I even have the MRI, I’m like, ‘OK, well this could possibly be it.'”
Why is glioblastoma so hard to treat?
Glioblastomas are aggressive cancers: They grow quickly and are likely to have invaded other parts of the brain and spinal cord by the point an individual is diagnosed.
Surgical removal of all the tumor is sort of not possible.
“It’s like octopus tentacles reaching into other parts of the brain,” said Honggang Cui, an associate professor of chemical and biomolecular engineering at Johns Hopkins Whiting School of Engineering.
Treatment typically involves surgery, chemotherapy and radiation, Cui said. But unless every cancer cell is eliminated, the tumor often comes back in what’s known as reoccurrence.
SurVaxM works by training the immune system to focus on and attack the cancer cells, so in the event that they do return, the body can pick them off, stopping a latest tumor from growing, said Michael Ciesielski, the CEO of MimiVax.
The approach is “promising,” Cui said. “This might bring hope to people who find themselves impacted by GBM.”
Participants within the trial will first have surgery to remove as much of the tumor as possible, followed by radiation and chemotherapy, with a drug called temozolomide, said Dr. Robert Fenstermaker, the chair of the neurosurgery department on the Roswell Park Comprehensive Cancer Center and co-creator of SurVaxM.
“There’s often a hiatus of a few month while radiation continues to be working, and it’s during that phase that we like to start out the vaccination because that is when the immune system has been rejuvenated,” he said.
The vaccine — given within the arm identical to a flu shot or Covid shot — consists of 4 doses, opened up over two months, followed by a booster dose every two months. Participants within the trial will either get the true vaccine for every shot or a shot of a placebo each time. Participants may even get a brain scan every two months to observe for signs of progression.
A necessity for various approaches
SurVaxM is not the primary try and create a vaccine to delay the reoccurrence of glioblastoma. Other cancer vaccines have targeted survivin, but none of them to date have reached mid- to late-stage clinical trials, based on Ciesielski.
Dr. Alyx Porter, a neuro-oncologist on the Mayo Clinic in Phoenix, said the approach is different from what’s been tried previously.
Targeted therapies like checkpoint inhibitors, for instance, have grown in popularity lately, improving survival in individuals with cancer including those with breast or lung cancers. But these drugs are far less effective for brain tumors, because they cannot cross the blood-brain barrier, a network of blood vessels that keeps foreign substances from entering the brain.
The assumption, Porter said, is that the antibodies generated by a vaccine would have the ability to succeed in the brain. But, she added, “the proof will probably be within the pudding with the trial.”
Results are still a ways off: Based on Ciesielski, the corporate doesn’t expect its earliest results from the Phase 2b trial until mid-2024, and the trial likely won’t be accomplished for one more 18 to 24 months after that. If successful, the corporate may have to conduct a bigger Phase 3 clinical trial.
The high mortality rates of glioblastoma “warrants people pressing the sting and looking for out latest treatments and allowing us to actually maximize where immunotherapy may profit,” said Porter, who just isn’t involved with the SurVaxM trial.
To date, the drug appears to be secure, Fenstermaker said. Known unwanted side effects from the vaccine include fever, itching, redness and muscle aches.
Ciesielski said the corporate can also be trying to use the vaccine on other types of cancer, including multiple myeloma and neuroendocrine tumors, a rare type of cancer that may develop wherever there are neuroendocrine cells, that are present in various organs including the lungs, pancreas and gastrointestinal tract.
For Kassman, of Buffalo, Latest York, she feels “incredibly lucky” for a probability at a possible treatment.
“I could have ignored this whole thing again for a few weeks,” she said, “and I won’t be here to speak about this with you.”