MimiVax Announces Positive Interim Analysis in Ongoing SurVaxM Clinical Trial

Highlights:

• Ongoing clinical trial of SurVaxM in glioblastoma [SURVIVE] has successfully progressed following an interim analysis of trial data
• The clinical trial is designed to evaluate the safety, efficacy, and overall benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment combined with SurVaxM
• The fully enrolled Phase 2b SURVIVE study will continue as planned to collect more data

BUFFALO, N.Y., Feb. 12, 2025 /PRNewswire/ -- MimiVax, Inc., a leader in clinical-stage pharmaceutical research, today announced that its now fully enrolled Phase 2b clinical trial of SurVaxM in glioblastoma, [SURVIVE] (NCT05163080), has successfully progressed following the first interim analysis of trial data. The analysis, conducted as part of the company's rigorous clinical development program, has provided valuable insights that support the continued advancement of the trial. The purpose of this study is to determine whether adding SurVaxM to standard-of-care (resection, radiation/chemotherapy) is better than standard treatment alone for patients with newly diagnosed glioblastoma.

While the company is unable to disclose specific details about the interim analysis due to regulatory requirements set forth by the U.S. Food and Drug Administration (FDA), MimiVax remains confident in the potential of SurVaxM and is committed to advancing the study as planned.

"We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers. Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program," said Dr. Michael Ciesielski, CEO of MimiVax. "We are working closely with the FDA to ensure compliance with regulatory guidelines as we move forward with the trial."

Based on the results of the recent interim futility analysis, and ongoing review by the study's Independent Data Safety Monitoring Committee, the SURVIVE trial will continue as designed without modification.

The clinical trial is designed to evaluate the safety, efficacy, and overall benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment combined with SurVaxM at 11 participating major Cancer Centers in the United States. The company will provide updates at appropriate milestones, in accordance with regulatory requirements.

MimiVax thanks all participants, healthcare professionals, clinical support teams and investigators involved in the study for their continued support and commitment to the advancement of SurVaxM.

About SurVaxM: 

SurVaxM is a peptide mimic immunogen that targets 'survivin', a cell-survival protein present in most glioblastomas and in many other cancers. SurVaxM stimulates a patients' own immune response to control tumor growth and prevent disease recurrence. Because survivin is present in most cancers, SurVaxM could potentially have applicability in many other forms of cancer.

About MimiVax, Inc.: 

MimiVax, Inc. is a Delaware-incorporated, clinical-stage biotechnology company focused on immunotherapy research and clinical translation of new agents for cancer treatment. 

MimiVax was formed as a spin-off from Roswell Park Comprehensive Cancer Center to develop and commercialize its lead candidate SurVaxM and has been graciously supported by private investors and donations to Roswell Park. For more information, visit www.mimivax.com

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the company's current expectations, estimates, and projections about the company's business and industry, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements.

SOURCE MimiVax, Inc.