Disrupting cancer through SurVaxM immunotherapy

At MimiVax, our mission is to disrupt cancer. We are dedicated to improving survival and sending hope to cancer patients

News and Events

“Phase IIa Study of SurVaxM plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma”

-Journal of Clinical Oncology 41, no. 7 (2023) 1453-1465

“Developing a new cancer immunotherapy, SurVaxM from bench to bedside”

-Nature, Biopharma Dealmakers ISSN 2730-6283 (online) ISSN 2730-6275 (print)

  • The U.S. Food and Drug Administration (FDA) has granted supplemental orphan-drug designation (ODD) to SurVaxM for use in patients with malignant gliomas.
  • New orphan designation broadens the patient population for potential use of SurVaxM to include forms of adult and pediatric malignant gliomas other than glioblastoma.
  • ODD expands market exclusivity of SurVaxM beyond its previous designation of adult glioblastoma.

May 30, 2024

MimiVax announced today that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MimiVax’s SurVaxM vaccine being studied for the treatment of newly diagnosed glioblastoma (nGBM).

“The receipt of Fast Track Designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma,” said Michael Ciesielski, CEO of MimiVax. “This designation is a key component in our journey to help patients with glioblastoma to live longer.”

  • Enhanced access to the FDA including opportunities for more frequent meetings and direct consultation .
  • Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission.
  • FTD also allows for a ‘rolling review’ in which MimiVax may submit completed sections of the SurVaxM NDA as they become available, rather than at the end development.

October 12, 2023

The current study found that 51% of nGBM patients receiving SurVaxM had survived at least 2 years and 41% had survived 3 years, considerably higher rates than has been seen historically from standard care.

MimiVax is pleased to announce the published manuscript of the now completed Phase 2A study of SurVaxM, a cancer vaccine, in newly diagnosed glioblastoma (nGBM) in the Journal of Clinical Oncology, authored by researchers from several prominent US cancer centers. 
 
A follow-up Randomized, Blinded Placebo-Controlled Phase 2B Clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 10 cancer centers
across the USA.
 
Manuscript available at:
JCO.22.00996 

December 15, 2022

MimiVax

Our vision, to disrupt cancer with the development of highly innovative immunotherapies aimed at increasing patient survival rates

PartnerING

MimiVax is improving outcomes and quality of life for those suffering from devastating diseases as well as strengthening the biomedical startup ecosystem of Buffalo, New York.

Pipeline

We’re exploring new ways of stimulating the immune system to fight cancer cells leveraging our proprietary survivin-targeting technology.

Clinical Trials

SurVaxM is presently being studied in glioblastoma (newly diagnosed and recurrent), multiple myeloma and neuroendocrine tumors (NET). 

OUR MISSION

To disrupt cancer with innovative immunotherapies

SurVaxM is currently being evaluated in:
-Phase 2b: adult newly diagnosed glioblastoma
-Phase 1: SurVaxM + lenalidomide in multiple myeloma
-Phase 1: Metastatic NeuroEndocrine Tumors (NET)
-Phase 1: Pediatric relapsed/recurrent high grade gliom

Clinical trials
0
Disease Indications
0
Patient Participants
205
Doses
1495

Disrupt cancer with the development of highly innovative immunotherapies

Partner with us

MimiVax is a privately held, clinical-stage biotechnology company that was formed in 2012 from Roswell Park Comprehensive Cancer Center. This was quickly followed by a prestigious award from the American Cancer Society, and support from the Roswell Park Alliance Foundation enabling clinical studies of SurVaxM for glioblastoma. If you are an investor interested in MimiVax, please reach out via the contact form below.

Contact us

To view a listing of investigational clinical trials open to patient enrollment that include SurVaxM, please visit clinicaltrials.gov.

For general inquiries: [email protected]

Help accelerate the pace of SurvaxM clinical trials

The Roswell Park Alliance Foundation is the charitable arm of Roswell Park Comprehensive Cancer Center, where SurVaxM research started. Donations to the Alliance Foundation helped make early phase SurVaxM clinical studies possible and will continue to accelerate the pace and scope of future SurVaxM clinical trials. Please follow this link to make a potentially life changing contribution to this critical effort.