MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma

MimiVax, Inc., a biotechnology company focused on the development of glioblastoma vaccine therapy, announced today 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).

MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma
A randomized, blinded placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM 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.
About MimiVax, Inc.:
MimiVax, Inc. is a Delaware-incorporated, clinical-stage biotechnology company focused on immunotherapy research and clinical translation of new agents for cancer treatment.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!