On July 15, 2026 MimiVax Inc., a clinical-stage biotechnology company dedicated to the development of innovative cancer immunotherapies, reported that data cutoff has been reached for the SURVIVE trial (NCT05163080), the Company’s Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating SurVaxM in patients with newly diagnosed glioblastoma (nGBM). The dataset has been transferred to the trial’s independent statistical team, who have initiated the pre-specified analysis.
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The SURVIVE trial, which completed enrollment in 2024 across 11 major cancer centers in the United States, is designed to evaluate whether adding SurVaxM to standard-of-care adjuvant temozolomide chemotherapy improves survival outcomes compared to temozolomide alone in patients with newly diagnosed glioblastoma. The study enrolled 249 patients with newly diagnosed, resected glioblastoma across institutions 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.
"Five years ago, we began the SURVIVE trial with the conviction that SurVaxM will meaningfully extend survival for patients diagnosed with glioblastoma. Completing the data cutoff brings us one step closer to achieving that goal," said Michael Ciesielski, PhD, chief executive officer and co-founder of MimiVax. "None of this would have been possible without the patients and families who trusted us with their care, and the clinical teams who made this trial work."
"Reaching the data cutoff is a milestone our team, our investigators, and most importantly our patients have been working toward for years," said Robert Fenstermaker, MD, chief medical officer and co-founder. "With the independent analysis now underway, we look forward to sharing topline results soon."
Glioblastoma is the most common and aggressive malignant primary brain tumor in adults, with a median overall survival of approximately 16 – 18 months with standard therapy alone. The SURVIVE trial was built upon encouraging results from the preceding Phase 2a study of SurVaxM in 63 newly diagnosed glioblastoma patients, which demonstrated a median overall survival of 25.1 months. Fifty percent of patients receiving SurVaxM survived at least two years, and 19 percent survived at least five years. Individuals with the strongest immune responses had a much longer median overall survival (mOS) of 43.1 months.
About the SURVIVE Trial
SURVIVE (NCT05163080) is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating SurVaxM in combination with standard-of-care adjuvant temozolomide versus temozolomide alone in patients with newly diagnosed, resected glioblastoma. The SURVIVE trial is being conducted at 11 major cancer centers across the United States.
About SurVaxM
SurVaxM is a first-in-class, patented peptide mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in approximately 95 percent of glioblastomas. Delivered via subcutaneous injection, SurVaxM is engineered to stimulate patients’ own immune response to recognize and attack survivin-expressing cancer cells, with the goal of controlling tumor growth and preventing recurrence. SurVaxM holds FDA Fast Track Designation for newly diagnosed glioblastoma and is being evaluated across multiple cancer indications, including glioblastoma, neuroendocrine tumors, multiple myeloma, and pediatric brain cancer.
(Press release, MimiVax, JUL 15, 2026, View Source;utm_medium=rss&utm_campaign=mimivax-announces-data-cutoff-for-phase-2b-survive-trial-of-survaxm-in-newly-diagnosed-glioblastoma [SID1234669233])