Buffalo, NY. December 15, 2022 – MimiVax is pleased to announce the published manuscript of the now completed Phase IIa study of SurVaxM, a cancer vaccine, in newly diagnosed glioblastoma (nGBM) in the Journal of Clinical Oncology, authored by researchers from several prominent US cancer centers. Glioblastoma is a rare disease with severe unmet medical need. SurVaxM was developed to bring a paradigm shift to a field with few advancements in recent years. The current study found that 51% of nGBM patients receiving SurVaxM had survived at least 2 years and 41% had survived 3 years, considerably higher rates than has been seen historically from standard care.
This multi-center, open label, single arm, phase IIa trial in adult patients with nGBM was approved by the institutional review boards at each of the participating hospitals [NCT02455557]. All participants signed an informed consent prior to participation and study related tests. Patients were enrolled and treated at the following institutions: Roswell Park Comprehensive Cancer Center (which also served as the central trial site), Beth Israel Deaconess Medical Center, Cleveland Clinic, Dana-Farber Cancer Institute and Massachusetts General Hospital.
Of 63 patients enrolled, 60 (95.2%) remained progression-free 6 months after diagnosis to successfully reach the study primary endpoint. Additional endpoints of median Progression Free Survival (mPFS) of 11.4 months and median Overall Survival (mOS) of 25.9 months, measured from first dose of SurVaxM. SurVaxM was shown to stimulate survivin-specific cytotoxic T-cells and produce anti-tumor antibody responses which correlated with survival. Patients with the strongest antibody responses had a mOS of 43.1 mos. SurVaxM appeared to be safe and well-tolerated and may represent a promising new therapy emerging for nGBM.
“These promising results seen in the Phase IIa study compare favorably to the historical contemporary outcomes seen in glioblastoma. Additionally, we are excited about the benefit that was seen in both in the methylated [temozolomide-sensitive] and unmethylated [temozolomide-resistant] patients. There has also been significant interest in the randomized Phase IIb ongoing study.” –Manmeet Ahluwalia, MD, MBA; Fernandez Family Foundation Endowed Chair in Cancer Research, Chief of Medical Oncology, Deputy Director and Chief Scientific Officer at Miami Cancer Institute, part of Baptist Health South Florida.
A follow-up Randomized, Blinded Placebo-Controlled Phase IIb Clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 10 cancer centers across the USA (enrolling at 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 Langone and UCSF Medical Center). See clinical trials.gov for enrollment details and locations.
“We are finally starting to see immunotherapy having an impact upon difficult to manage diseases like glioblastoma and are excited to be able to contribute in a meaningful way to cancer care to provide hope for glioblastoma patients” –Michael Ciesielski, PhD; Chief Executive Officer, MimiVax
“Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma.” J Clin Oncol, Dec. 15, 2022 Manuscript is available online for free open-access at: https://ascopubs.org/doi/full/10.1200/JCO.22.00996
Trials for SurVaxM were graciously supported by Roswell Park Comprehensive Cancer Center and the Roswell Park Alliance Foundation.
About MimiVax LLC:
MimiVax LLC is a New York based private, clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutics for cancer treatment. The Company was formed to develop and commercialize its lead candidate SurVaxM. For more information on MimiVax, visit www.mimivax.com.
SurVaxM is a first-in-class, patented peptide mimic immunogen that targets survivin, a cell-survival protein present in 95% of glioblastomas and in many other cancers. SurVaxM stimulates a patients’ own immune response to control tumor growth and prevent recurrence. Because survivin is present in most cancers, SurVaxM could have applicability in other cancers.