SurVaxM. Photo Courtesy: 2019 Roswell Park.
SurVaxM. Photo Courtesy: 2019 Roswell Park.

SurVaxM, also known as SVN53-67/M57-KLH peptide vaccine, an immunotherapeutic, has demonstrated safety and tolerability in a Phase I study in people with malignant gliomas. The vaccine, being developed by MimiVax, is based on technology licensed from Roswell Park, the only National Cancer Institute-designated comprehensive cancer center in Upstate New York.

The investigational drug, which is designed to stimulate the immune system to kill tumor cells that contain survivin, a cell-survival protein that helps cancer cells to resist conventional treatments, was also evaluated in a Phase II clinical trial in adults with newly diagnosed glioblastoma. The results of this trial showed an increase in progression free survival (PFS) and overall survival (OS).

Glioblastoma, a malignant neuroepithelial neoplasm in the central nervous system, is the most common form of brain cancer in adults. As grade IV, the most aggressive type in the World Health Organization’s (WHO) classification of central nervous system tumors. Glioblastoma is mainly treated with surgery, radiotherapy, chemotherapy and other supportive therapy. The median survival for patients treated with standard therapy is between 14.7 to 16.6 months.

Photo 1.0: Robert Fenstermaker, MD, Chair of Neurosurgery at Roswell Park and Chief Medical Officer of MimiVax (left), and Assistant Professor of Neurosurgery at Roswell Park and Chief Executive Officer of MimiVax and Michael Ciesielski, Ph.D. Photo courtesy: MimiVax LLC./ Roswell Park.

The drug, which is manufactured in the United States, has been studied most extensively in patients with glioblastoma, an aggressive and hard-to-treat brain cancer. However, the drug’s target, survivin, a member of the inhibitor of apoptosis (IAP) protein family, also called baculoviral inhibitor of apoptosis repeat-containing 5 or BIRC5, inhibits caspases and blocks cell death. This protein is highly expressed in most cancers and is associated with a poor clinical outcome and present in many other types of cancer, including multiple myeloma, neuroendocrine, medulloblastoma, melanoma, kidney, breast and ovarian tumors.

SurVaxM triggers T-cell and B cell immunity simultaneously with unique cellular and antibody-mediated anti-tumor responses.

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Earlier this week MimiVax confirmed that the company, spun off from Roswell Park in 2012, has entered into a exclusive licensing agreement for SurVaxM with Shanghai Fosun Pharmaceutical (Group).

Foto 2.0: Signing ceremony between Fosun Pharma and MimiVax – allowing Fosun Pharma to diversify its product portfolio and gain an innovated Central Nervous System (CNS) oncology treatment. Photo courtesy: Shanghai Fosun Pharmaceutical (Group).

Under the terms of the agreement, Fosun Pharma and MimiVax will collaborate in the development of commercialization of SurVaxM in the United States and specified territories in China. Based on the agreement, MimiVax will also receive an upfront US $ 10 million which will partially fund upcoming pivotal clinical trials in both the United States and China.

MimiVax is also eligible to receive an additional US $ 28 million in developmental milestones and US $ 110 million in sales milestones.

Clinical studies
Based upon positive results from initial phase I and phase II studies, the team expects to advance to large, multicenter randomized phase II trials in both in China and in the U.S. A five center, single-arm phase II study in 63 patients with newly diagnosed glioblastoma (nGBM) demonstrated significantly longer survival time for patients treated with SurVaxM, with 93.5% alive a year after diagnosis, compared to expected 65% survival based on historical studies.[1]

Results presented during the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) held earlier this year, showed that a combination therapy with the vaccine was more effective than standard therapy for nearly all patients. [1]

Changing cancer treatment
“Immunotherapies are changing the way we treat many cancers, but none of the immunotherapies currently approved by the U.S. Food and Drug Administration (FDA) are an option for patients with glioblastoma, and the approved treatment options we do have for patients with the disease remain quite limited both in number and in effectiveness,” noted Robert Fenstermaker, MD, who is Chair of Neurosurgery at Roswell Park and Chief Medical Officer of MimiVax.

“We’re grateful to Fosun Pharma for recognizing the promise that SurVaxM holds, and eagerly look forward to working with our partners both in the United States and China to get these additional clinical studies underway,” Michael Ciesielski, PhD, added, who is Assistant Professor of Neurosurgery at Roswell Park and Chief Executive Officer of MimiVax.

“The initial laboratory investigations that paved the way to where we are now would not have been possible without individual donors who contributed to fundraising efforts like The Ride For Roswell,” Fenstermaker concluded.

SurVaxM was awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) in 2017.

a The median age of the participating patients was 60 years of age. All patients underwent standard treatment, involving craniotomy, radiation and treatment with temozolomide both before and after surgery. Immune response was assessed by detection of a survivin-specific antibody and CD8+ T-cell levels. Patients were followed for safety, six-month progression-free survival, 12-month overall survival and immunologic response.

Clinical trials
SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma – NCT02455557
– Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence – NCT04013672
– Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors – NCT03879694
– SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy – NCT02334865

[1] Ahluwalia MS, Reardon DA, Abad AP, Curry WT, Wong ET, Belal A, Qiu J, Mogensen K, Schilero C, Hutson A, Casucci D, et all. SurVaxM with standard therapy in newly diagnosed glioblastoma: Phase II trial update. J Clin Oncol 37, 2019 (suppl; abstr 2016). DOI:
10.1200/JCO.2019.37.15_suppl.2016 [ASCO Meeting library]

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