FDA Grants Fast Track Designation to SurVaxM for Newly Diagnosed Glioblastoma

The Food and Drug Administration (FDA) has granted a Fast Track Designation to SurVaxM, a vaccine currently being studied for the treatment of patients with newly diagnosed glioblastoma (nGBM), a type of brain cancer, according to an announcement from MimiVax Inc., the biotechnology company developing SurVaxM.

SurVaxM is currently being studied in the SURVIVE phase 2b clinical trial, which is seeking to recruit approximately 265 patients with glioblastoma. The study will compare length of survival among patients treated with the current standard of care — the chemotherapy Temodal (temozolomide) — when paired with SurVaxM, as compared with treatment of Temodal plus a placebo, according to the trial’s listing on clinicaltrials.gov.

SURVIVE launched in November of 2021, and the trial is expected to be completed in April of 2024, according to clinicaltrials.gov.

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Results of a prior phase 2a clinical trial which were first published online in late 2022 via the Journal of Clinical Oncology found that 95.2% of evaluable patients with resected (surgically removed) nGBM were progression-free six months after receiving their diagnosis, while the median progression-free survival (the time a patient lives without a disease spreading or worsening) was 11.4 months and the median overall survival (the time a patient lives following treatment, regardless of their disease status) was 25.9 months.

SurVaxM, which stimulates a patient’s immune system in a manner akin to the flu vaccine, was discovered by researchers at Roswell Park Comprehensive Cancer Center in Buffalo, New York.

“What (SurVaxM) does is it stimulates a patient’s lymphocytes, white blood cells and antibodies to home in and attack the tumor cells, so it’s your own immune cells that are going after the tumor and hopefully destroying it,” Dr. Michael Ciesielski, one of the vaccine developers and an assistant professor of neurosurgery in the department of neurosurgery at Roswell Park, told CURE in 2019.

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SurVaxM received an Orphan Drug Designation from the FDA in 2017.

The FDA Fast Track Designation is “designated to facilitate the development and expedite the review of drugs to treat serious medical conditions and fulfill unmet medical need,” according to MimiVax.

"The receipt of Fast Track Designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma," Michael Ciesielski, CEO of MimiVax, said in the news release. "This designation is a key component in our journey to help patients with glioblastoma to live longer."

The Fast Track Designation for SurVaxM in the latest promising development for patients with glioblastoma. Earlier this month, the agency granted the same designation to BRAF inhibitor AMB-1310 for the treatment of patients with glioblastoma (GMB) who are carrying the BRAF V600E mutation.

Patients have also been dosed in at least three additional current trials studying novel treatments for glioblastoma.

There are an average of 12,000 cases of glioblastoma each year, with the cases of the disease representing approximately 14% of all primary brain tumors, according to the American Brain Tumor Association.

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