• Interim analysis shows significant survival benefit compared to historical standard of care;
  • Combination of SurVaxM and standard therapy was well-tolerated, with few serious side effects;
  • MimiVax to share findings at ASCO annual meeting.

BUFFALO, NY, USA I May 21, 2018 I MimiVax LLC, a clinical-stage biotechnology company developing immunotherapeutics and targeted therapies for cancer treatment, today announced positive interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM). These promising interim results support further development of SurVaxM in combination with standard therapy as a potential treatment for glioblastoma. A randomized trial of SurVaxM in glioblastoma is planned, pending completion of this study and review at the end of Q4 2018.

Key interim results include 91% of patients receiving SurVaxM in combination therapy achieving 12-month overall survival (OS-12), compared to 61% historical standard of care; 96% achieved six-month progression-free survival (PFS-6), compared to 54% historical standard of care. In this study, 13 of 63 patients continue to be without progression for over 12 months. Evidence to date shows that SurVaxM is easy to administer, safe, tolerable with few serious adverse effects.

The study is being conducted at five sites, namely Roswell Park Comprehensive Cancer Center, the Cleveland Clinic, Dana-Farber Cancer Institute, Massachusetts General Hospital and Beth Israel Deaconess Medical Center. MimiVax will present these findings at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.

“These interim Phase II trial results in newly diagnosed glioblastoma patients are very promising and offer the potential for longer-term survival in this group where there is great unmet medical need. We believe this drug has the potential to change the glioblastoma treatment paradigm,” said the study’s senior author, SurVaxM co-inventor Robert Fenstermaker, MD, who is Chair of Neurosurgery at Roswell Park and Chief Medical Officer at MimiVax.

SurVaxM, which was invented at Roswell Park Comprehensive Cancer Center, targets a cell-survival protein called survivin that is present in 95% of patients with glioblastomas, and also in patients with many other cancers. SurVaxM has dual mechanisms of action to stimulate a patient’s T-cell immunity and unique antibody-directed inhibition of the survivin pathway to control tumor growth and prevent or delay tumor recurrence. SurVaxM has been awarded orphan drug designation by the U.S. Food and Drug Administration (FDA).

Co-inventor Michael Ciesielski, PhD, Assistant Professor of Neurosurgery at Roswell Park and Chief Executive Officer for MimiVax, commented: “Glioblastoma is one of the most common and aggressive forms of brain cancer, with few effective treatment options. That dire need underscores the importance of these promising interim results, as we seek to develop new and better therapies. And because survivin is present in a huge percentage of cancers in general, we expect that SurVaxM could have broad applicability in many cancers beyond glioblastoma.”

The interim analysis includes 63 patients with an age range from 20-82 years (median = 60), male:female = 32:23.

PFS-6 was 96.3% (+2.8, -10.3)(n = 55) measured from diagnosis. OS-12 was 90.9% (+6.1, -16.5)(n = 33) from diagnosis. The regimen was generally well-tolerated, and drug-related adverse events were mild. The drug was highly active in stimulating immunologic response against tumor cells and produced survivin-specific antibody (IgG) titers and CD8+ T-cell responses. The drug also has the capacity to stimulate immune helper cell support, which is important for robust and sustained antitumor CD8+ activity.

Study Design

The trial was designed to determine PFS-6, OS-12 and immunologic response in nGBM patients treated with concurrent temozolomide (TMZ) and radiation, followed by adjuvant TMZ and survivin-targeted immunization with SurVaxM.

The trial is a single-arm, multi-center Phase II trial conducted in 63 evaluable patients with nGBM.  Patients who underwent craniotomy with gross total resection, followed by chemoradiation, were eligible. SurVaxM is delivered through a non-invasive subcutaneous injection of four serial priming doses of SurVaxM (500 mcg) with Montanide and sargramostim (100 mcg) every two weeks, followed by standard adjuvant TMZ and maintenance SurVaxM every 12 weeks until progression. Endpoints were designed to determine PFS-6, OS-12 and immunologic response in nGBM patients treated with the survivin-targeted immunization SurVaxM. Interim data presented here and at ASCO was obtained as of February 2018 and final study data is expected in Q4 2018.

Research on SurVaxM has led to the development of additional platform agents, including a therapeutic anti-survivin monoclonal antibody and survivin-targeted CAR T cells, both of which are under development by scientists and clinicians at MimiVax and Roswell Park.

This Phase II study has been supported by donations from the Roswell Park Alliance Foundation and through private investment. Manmeet Ahluwalia, MD, of the Cleveland Clinic is lead principal investigator of the Phase II trial and first author of the study to be presented at ASCO 2018.

For more information about the Phase II clinical trial, call 1-800-ROSWELL (1-800-767-9355) or send an e-mail to AskRoswell@Roswellpark.org“>AskRoswell@Roswellpark.org. Additional details are available here.

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 in 2012 to develop and commercialize its lead candidate SurVaxM. SurVaxM is currently undergoing Phase II study in glioblastoma and Phase I study in multiple myeloma. For more information on MimiVax, visit www.mimivax.com.

About SurVaxM:

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 as well. SurVaxM has simultaneous dual mechanisms to stimulate patients’ own T-cell immunity and unique antibody-directed inhibition of the survivin pathway to control tumor growth and prevent recurrence. SurVaxM has demonstrated safety and tolerability in a Phase I study in patients with recurrent or progressive malignant glioma (brain tumors). With support from Roswell Park and private investors, SurVaxM has entered a Phase II clinical trial in adults with newly diagnosed glioblastoma at leading cancer centers, including Roswell Park Comprehensive Cancer Center, the Cleveland Clinic, Dana-Farber Cancer Institute, Massachusetts General Hospital and Beth Israel Deaconess Medical Center. A Phase I clinical trial evaluating SurVaxM in combination with REVLIMID® (lenalidomide) as maintenance therapy for adults with multiple myeloma has also been initiated with support from Celgene (marketer of REVLIMID®). Because survivin is present in most cancers, including multiple myeloma, melanoma, ovarian, renal, lymphoma, prostate and breast cancers, SurVaxM could have applicability in other cancers.

About Glioblastoma:

Glioblastoma is the most common and aggressive form of primary brain cancer in adults. Nonetheless, it is still considered a rare disease, with around 14,000 new cases diagnosed annually. Median progression-free survival is around 7 months. With standard therapy (surgery followed by chemoradiation and then adjuvant chemotherapy), the median overall survival is only 15 months, with 3-5% of patients living 5 years. Although a large body of basic and clinical research has been devoted to improving treatment for this disease, survival has improved only modestly in the past several decades, leaving a substantial unmet medical need.

About Roswell Park:

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@roswellpark.org“>ASKRoswell@roswellpark.org.