MimiVax, LLC Receives FDA Approval to Initiate a New Phase 2b Clinical Study for the Treatment of Newly Diagnosed Glioblastoma
- MimiVax has received a "Study May Proceed" notification from the US FDA to initiate a Phase 2b clinical trial of SurVaxM in newly diagnosed glioblastoma
-Completed Phase 2a clinical studies confirm SurVaxM's strong proof of concept efficacy and safety profile to address newly diagnosed glioblastoma, which is currently a severe unmet medical need
-Phase 2b "SURVIVE" clinical trial will evaluate SurVaxM in a randomized, blinded, placebo-controlled, multi-center study to initially enroll at several U.S. sites, additional sites in the United States and China to follow
Nov 15, 2021, 10:00 ET
BUFFALO, N.Y., Nov. 15, 2021 /PRNewswire/ -- MimiVax LLC, a clinical-stage biotechnology company in Buffalo, NY, USA, developing immunotherapeutics for cancer and autoimmune diseases, announced today that the company has received a "Study May Proceed" notification from the United States Food and Drug Administration (FDA) to begin a Phase 2b trial, for SurVaxM in newly diagnosed glioblastoma entitled "SURVIVE." MimiVax has been operating through Covid related delays but is excited to now be able to launch a new clinical trial in 2021. The "SURVIVE" trial will evaluate SurVaxM in a randomized, blinded, placebo-controlled, multi-center study designated to compare standard of care (temozolomide) with or without the addition of SurVaxM. The primary objective and endpoint for the study will be overall survival. Additional objectives will evaluate molecular predictors of response, including MGMT methylation status, IDH1 mutation and survivin-specific responses.
Glioblastoma is the most deadly and unfortunately the most common adult brain tumor affecting approximately 14,000 people/year in the USA. Only 25% of patients generally survive 1 year and less than 5% survive longer than 5 years, while standard of care has remained largely unchanged over the last 15 years.
SurVaxM is the first of its kind patented peptide vaccine, developed at Roswell Park Comprehensive Cancer Center. SurVaxM targets survivin, a cell-survival protein present in glioblastoma and many other cancers. A multi-center Phase 2a open label study in newly diagnosed glioblastoma was completed in 2020 (NCT02455557). Data from this study indicated a median overall survival of 25.8 months with a range of 19.5 to 43.5+ mos. Those survival statistics compare favorably with current standard of care, where patients are expected to have a median overall survival of 16 months, with a range of 14-18.4 mos.
MimiVax is collaborating and partnering for SurVaxM in several other indications; multiple myeloma in combination with Revlimid (BMS) (fully enrolled); recurrent glioblastoma in combination with Keytruda (Merck) (fully enrolled); and Neuro-endocrine Tumors (NET) (recruiting at Roswell Park).
The SurVaxM project has been graciously supported by donations to the Roswell Park Comprehensive Cancer Center and by private investors, including Buffalo Capital Partners and Varia Ventures.
About MimiVax LLC
At MimiVax, our mission is to disrupt cancer. We are dedicated to improving survival and sending hope to cancer patients. MimiVax is a NY based private, clinical-stage biotechnology company formed in 2012 to develop and commercialize SurVaxM and pipeline immunotherapeutics. For more information visit www.mimivax.com.
SOURCE MimiVax, LLC
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