RARE Daily

FDA Grants Fast Track Designation to MimiVax’s SurVaxM for Newly Diagnosed Glioblastoma

October 13, 2023

Rare Daily Staff

The U.S. Food and Drug Administration has granted Fast Track designation to MimiVax’s SurVaxM vaccine being studied for the treatment of newly diagnosed glioblastoma, a rare cancer of the brain.

Glioblastoma (GBM) 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. It is a first-in-class, patented peptide mimic immunogen that targets survivin, a cell-survival protein present in 95 percent of glioblastomas and in many other cancers. SurVaxM stimulates a patient’s own immune response in an effort to control tumor growth and prevent disease recurrence. Because survivin is present in most cancers, SurVaxM could potentially have applicability in other cancers.

A randomized, blinded placebo-controlled phase 2b clinical trial of SurVaxM for nGBM is now recruiting at 11 cancer centers across the United States. Positive final data from the previous phase 2a study of SurVaxM for nGBM, published in the Journal of Clinical Oncology, found that 51 percent of patients receiving SurVaxM survived at least 2 years and 41 percent 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.

“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 include enhanced access to the FDA including opportunities for more frequent meetings and direct consultation throughout the remaining development of the therapeutic. Drugs with Fast Track designation are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application submission, which may result in faster product approval. Fast Track also allows for a ‘rolling review’ in which a company may submit completed sections of the NDA as they become available, rather than at the end when completed.

Photo: Michael Ciesielski, CEO of MimiVax

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