Pharma Focus Europe

Mimivax Has Been Granted Fast Track Designation by the Fda for Survaxm in the Management of Newly Diagnosed Glioblastoma

Friday, October 13, 2023

MimiVax, a biotechnology company specializing in glioblastoma vaccine therapy development, recently announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for their SurVaxM vaccine, which is currently being investigated for the treatment of newly diagnosed glioblastoma (nGBM).

MimiVax is actively recruiting participants for a Phase 2b clinical trial of SurVaxM for nGBM, known as SURVIVE (Clinical Trial Identifier: NCT05163080). This trial is underway at 11 leading cancer centers across the USA, including institutions such as Roswell Park Comprehensive Cancer Center, Miami Cancer Institute, Cleveland Clinic, Dana-Farber Cancer Institute, Overlook Medical Center, Norton Cancer Institute, Fred Hutchinson Cancer Center, Texas Oncology, NYU, Northwell Health, and UCSF. You can find enrollment details and locations on

Notably, the previous Phase 2a Study of SurVaxM for nGBM, the results of which were published in the Journal of Clinical Oncology, showed promising outcomes. It revealed that 51% of patients who received SurVaxM survived for at least 2 years, and 41% survived for at least 3 years. The median Overall Survival for patients with nGBM in this study was 25.9 months, significantly higher than what would typically be expected with standard therapy alone. MimiVax is committed to completing the Phase 2b SURVIVE study and securing the necessary funding to advance SurVaxM through the FDA approval process. This is especially important because glioblastoma is a rare disease with substantial unmet medical needs, and SurVaxM represents a potential breakthrough in a field with limited recent advancements.

Michael Ciesielski, the CEO of MimiVax, emphasized the significance of receiving Fast Track Designation, stating, "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. This designation is a key component in our journey to help patients with glioblastoma to live longer."



Thermo Fisher Scientific - mRNA ServicesWorld Orphan Drug Congress 2024World Vaccine Congress Europe 2024Advanced Therapies USA 2024