MimiVax Announces Positive Interim Analysis in Ongoing SurVaxM Clinical Trial

MimiVax, Inc. announced that its fully enrolled Phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma (NCT05163080) has successfully progressed following its first interim analysis. The study is evaluating whether adding SurVaxM to standard-of-care treatment — resection, radiation and chemotherapy — improves outcomes over standard treatment alone.

Specific details of the interim analysis cannot be disclosed under FDA regulatory requirements. Based on the results of the interim futility analysis and ongoing review by the study’s independent Data Safety Monitoring Committee, the SURVIVE trial will continue as designed, without modification, at 11 participating cancer centers across the United States.

“We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers,” said Michael J. Ciesielski, PhD, Chief Executive Officer. “Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program. We are working closely with the FDA to ensure compliance with regulatory guidelines as we move forward with the trial.”

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About SurVaxM: SurVaxM is a peptide mimic immunogen that targets survivin, a cell-survival protein present in most glioblastomas and many other cancers. It is designed to stimulate a patient’s own immune response to control tumor growth and help prevent disease recurrence.

About MimiVax: MimiVax, Inc. is a Delaware-incorporated, clinical-stage biotechnology company focused on immunotherapy research and clinical translation of new agents for cancer treatment. The company was formed as a spin-off from Roswell Park Comprehensive Cancer Center to develop and commercialize its lead candidate, SurVaxM.