Overlook Medical Center in Summit, part of Atlantic Health System, has been selected as the only site in New Jersey, and one of the first three in the nation, to participate in a clinical trial of a unique vaccine that targets the protein that keeps cancer cells alive in brain tumors.
The “SURVIVE” Phase 2B trial, sponsored by MimiVax LLC, will allow doctors at Overlook to treat patients newly diagnosed with glioblastomas with SurVaxM, a first-of-its-kind vaccine that targets survivin, a cell-survival protein found in 95% of glioblastomas and many other cancers.
The neuro-oncology experts at Overlook are hoping that the vaccine will be the key to giving patients a better shot at long-term survival from the disease and improved function. For neuro-oncologist Robert Aiken, MD, the lead researcher for the trial at Overlook, that would mean the world to patients with glioblastoma, a debilitating condition with an average survivability of about 16 months.
“I think it represents the possibility of a true advance for this uniformly fatal disorder,” said Dr. Aiken, who is co-director of Overlook’s Gerald J. Glasser Brain Tumor Center. “The prospect of surviving for more years, while maintaining function would be an incredible gift for patients.”
SurVaxM is engineered to recognize survivin-expressing cancer cells as foreign and stimulate patients’ own immune response to control tumor growth and recurrence.
The vaccine is given to patients once they complete the typical post-surgical treatment of radiation and chemotherapy, which usually lasts about 6-8 weeks after surgery to remove the tumor. The vaccine is given every two weeks over a six-week period and then every two months over a 24-month period, from the first injection.
While vaccines are typically thought of as ways to prevent diseases, some vaccines can also be used in a therapeutic way as an immunostimulant (e.g., to treat cancer). SurVaxM is delivered through simple subcutaneous injection.
“MimiVax is excited to be partnering with a world-class health care system like Atlantic Health System to join our mission to disrupt cancer,” said Michael J. Ciesielski, PhD; CEO of MimiVax and neuro-oncology researcher. “We look forward to working with Dr. Aiken and his team to learn more about this important agent.”
Overlook Medical Center, the flagship of Atlantic Health System’s neuroscience program, has long been at the forefront of using vaccines to treat brain tumors. Dr. Aiken said he is encouraged by early data from SurVaxM’s Phase I trial and noted how this vaccine targets survivin.
“It is a directed therapy to the tumor. This is an ideal target,” said Dr. Aiken, who is board-certified in neurology by the American Board of Psychiatry and Neurology, and in neuro-oncology by the United Council for Neurologic Subspecialties.
Overlook’s Gerald J. Glasser Brain Tumor Center gives hope to more than a thousand families every year. The center is located in the heart of Atlantic Neuroscience Institute at Overlook, which has been nationally recognized for neuroscience care.
Overlook’s capabilities in treating brain tumors, including an integrated care team, cutting-edge surgical procedures like CyberKnife, as well as conformal radiation, targeted therapy and chemotherapy, surgery guided by fluorescent imaging, brain mapping and awake surgery – in addition to supportive care and comprehensive symptom management – makes it uniquely suited for the trial among hospitals in the region.
“Our team works tirelessly to utilize the latest and most promising techniques and treatment options to give patients the best chance at survival. This vaccine’s targeted approach offers a lot of potential, and we are excited to be part of the trial demonstrating its effects,” said Yaron Moshel, MD, co-director of the Glasser Brain Tumor Center.
SurVaxM demonstrated safety and tolerability in a Phase 1 study in patients with recurrent or progressive malignant glioma as well as a Phase 2a study of newly diagnosed glioblastoma. That led the way for further study; in November, MimiVax LLC, a clinical-stage biotechnology company in Buffalo, NY, USA, developing immunotherapeutics for cancer and autoimmune diseases, received authorization from the United States Food and Drug Administration (FDA) to begin this Phase 2b stage entitled “SURVIVE.”
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. Thus, SurVaxM could have broad applicability to many other types of cancer.
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