MimiVax, Inc., a biotechnology company focused on the development of glioblastoma vaccine therapy, announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MimiVax’s SurVaxM vaccine being studied for the treatment of newly diagnosed glioblastoma (nGBM).
A randomized, blinded placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 11 cancer centers across the USA (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). See clinicaltrials.gov for enrollment details and locations. 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 2 years and 41% survived at least 3 years. The median Overall Survival of 25.9 months with nGBM in this study is considerably higher than would be expected with standard therapy alone. MimiVax is focused on completing the Phase 2b SURVIVE study and securing funding necessary to bring SurVaxM through the FDA approval process. Glioblastoma is a rare disease with great unmet medical need. SurVaxM was developed to bring a paradigm shift to a field with few advances in recent years.
“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,” said Michael Ciesielski, CEO of MimiVax. “This designation is a key component in our journey to help patients with glioblastoma to live longer.”
Fast Track is a process designated to facilitate the development and expedite the review of drugs to treat serious medical conditions and fulfill unmet medical need. Significant benefits of FTD include:
- Enhanced access to the FDA including opportunities for more frequent meetings and direct consultation throughout the remaining development of SurVaxM.
- Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval.
- FTD also allows for a ‘rolling review’ in which MimiVax may submit completed sections of the SurVaxM NDA as they become available, rather than at the end development.