SurVaxM Vaccine Clinical Trials, Dosage, Indication, Side Effects
MimiVax Inc.'s SurVaxM is a first-in-class peptide mimic immunotherapeutic vaccine (immunotherapy) candidate targeting survivin, a cell-survival protein in 95% of glioblastoma and many other cancers. It is engineered to recognize survivin-expressing cancer cells as foreign and stimulate patients' immune response to control tumor growth and recurrence. SurVaxM is a brain cancer immunotherapy born in the labs of Roswell Park Comprehensive Cancer Center.
Positive Final Data from the Phase 2a Clinical Study of SurVaxM for nGBM, published in the Journal of Clinical Oncology, found that 51% of patients receiving SurVaxM survived at least two years, and 41% survived at least three years. The median Overall survival rate of 25.9 months with nGBM in this study is considerably higher than expected with standard therapy alone. A randomized, blinded, placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) is recruiting at cancer centers across the USA. On October 12, 2023, MimiVax announced that the United States Food and Drug Administration granted Fast Track Designation to the SurVaxM vaccine candidate being studied for treatment for diagnosed glioblastoma. In June 2024, the U.S. Food and Drug Administration (FDA) expanded the orphan drug designation for SurVaxM. MimiVax first received orphan drug status for SurVaxM in August 2017. The supplemental FDA designation awarded to MimiVax Inc. now applies to SurVaxM as a treatment for not just adult glioblastoma but a broader category of cancerous brain tumors: any malignant glioma in children or adults.
MimiVax Inc. is a NY-based, Delaware corporation, clinical-stage biotechnology company formed in 2012. The Company was initially formed as a spin-off from Roswell Park, supported by donations to Roswell Park. For more information on MimiVax, visit www.mimivax.com.
SurVaxM Vaccine Indication
Although SurVaxM was first tested in brain cancer, survivin is present in most cancers, including multiple myeloma, melanoma, ovarian, renal, lymphoma, prostate, and breast cancers. SurVaxM is an immunostimulant targeting survivin, a molecule in many cancers.
SurVaxM Vaccine Dosage
SurVaxM is delivered through a subcutaneous injection.
SurVaxM Vaccine News
June 21, 2024 - Roswell Park President and CEO Candace S. Johnson, PhD. “SurVaxM is one of the few treatment options for incurable brain cancer to reach late-stage clinical trials, and everyone who supports this work is helping to speed a highly promising cancer treatment to patients who may benefit from it.”
October 12, 2023 - "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."
December 15, 2022 - “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, Ph.D.; Chief Executive Officer, MimiVax
May 30, 2020 - MimiVax LLC announced a clinical collaboration to assess the combination of SurVaxM (MimiVax) and pembrolizumab (Keytruda; MERCK). SurVaxM is a patented peptide immunogen targeting survivin, a cell-survival protein in glioblastoma and many other cancers.
May 29, 2019 - MimiVax LLC, a clinical-stage biotechnology company developing immunotherapeutics for cancer and autoimmune diseases, announced upcoming presentations at leading scientific and industry events.
SurVaxM Vaccine Clinical Trial
A randomized, blinded, placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 11 cancer centers. Results from the fully accrued phase 2b SURVIVE trial are expected in 2025, and a pilot study of the vaccine in children and adolescents with several forms of brain cancer is underway. SurVaxM is also being studied as a treatment for neuroendocrine tumors and multiple myeloma in adults.
Clinical Trial NCT02455557: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma. This phase II trial studies the side effects and how well vaccine therapy works when given with temozolomide to treat patients with newly diagnosed glioblastoma.
