MimiVax Announces Data Cutoff for Phase 2b SURVIVE Trial of SurVaxM in Newly Diagnosed Glioblastoma

MimiVax Inc., a clinical-stage biotechnology company developing immunotherapies for cancer, announced that data cutoff has been reached for the SURVIVE trial (NCT05163080), evaluating SurVaxM in patients with newly diagnosed glioblastoma. The dataset has been transferred to the trial’s independent statistical team for pre-specified analysis.

The SURVIVE trial completed enrollment in 2024 across 11 major cancer centers in the United States, including Roswell Park Comprehensive Cancer Center, Dana-Farber Cancer Institute, Cleveland Clinic, Fred Hutchinson Cancer Center, UCSF, NYU, Miami Baptist Cancer Center, Northwell Health, Norton Cancer Institute, Overlook Medical Center and Texas Oncology. The study enrolled 249 patients to evaluate whether adding SurVaxM to standard adjuvant temozolomide chemotherapy improves survival compared with temozolomide alone.

“Completing the data cutoff brings us one step closer to our goal of meaningfully extending survival for glioblastoma patients,” said Michael J. Ciesielski, PhD, Chief Executive Officer.

“With independent analysis now underway, we look forward to sharing topline results soon,” said Robert A. Fenstermaker, MD, Chief Medical Officer.

Glioblastoma is the most common and most aggressive malignant primary brain tumor in adults, with a median overall survival of approximately 16–18 months under standard therapy. The SURVIVE trial builds on the earlier Phase 2a study, in which 63 patients had a median overall survival of 25.1 months, with 50% surviving at least two years and 19% at least five years.

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About SurVaxM: SurVaxM is a first-in-class peptide mimic immunotherapy targeting survivin, a protein present in approximately 95% of glioblastomas. It is designed to stimulate an immune response against survivin-expressing cancer cells and holds FDA Fast Track designation.

About MimiVax: MimiVax Inc. is a Delaware-incorporated, clinical-stage biotechnology company developing immunotherapies for cancer. The company holds exclusive global commercialization rights to SurVaxM.