Fast Track Designation Granted for Newly Diagnosed Glioblastoma Immunotherapy Candidate

A glioblastoma vaccine therapy candidate has been granted Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA).

Announced on October 12, 2023, MimiVax Inc.'s SurVaxM vaccine (immunotherapy) is being studied to treat newly diagnosed glioblastoma (nGBM).

Glioblastoma is a rare disease with great unmet medical need. 

SurVaxM is a first-in-class, patented peptide mimic immunogen that targets survivin, a cell-survival protein present in 95% of glioblastomas and in many other cancers.

SurVaxM stimulates a patient’s immune response to control tumor growth and prevents disease recurrence. Because survivin is present in most cancers, SurVaxM could potentially have applicability in other cancers.

"The receipt of FTD affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma," said Michael Ciesielski, CEO of MimiVax, in a press release.

"This designation is a key component in our journey to help patients with glioblastoma to live longer." 

A randomized, blinded, placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 11 cancer centers across the U.S.

Previously, positive Final Data from the previous Phase 2a Study of SurVaxM for nGBM, published in the Journal of Clinical Oncology, found that 51% of patients receiving SurVaxM survived at least two years, and 41% survived at least three years.

The median Overall Survival of 25.9 months with nGBM in this study is considerably higher than expected with standard therapy alone.