Roswell Park Cancer Innovation SurVaxM Granted FDA Fast Track Designation

BUFFALO, N.Y. — A promising cancer innovation developed at Roswell Park Comprehensive Cancer Center has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). The designation awarded to MimiVax Inc. provides more extensive and accelerated access to FDA resources for the company’s development of the novel cancer immunotherapy SurVaxM, which is now in late-stage trials around the country.

“We are enormously proud of the Roswell Park team’s work going back more than a decade to conceive of SurVaxM, show that it may benefit patients with hard-to-treat, highly deadly cancers and move it successfully from the lab bench to hundreds of patients around the country,” says Roswell Park President, CEO and M&T Bank Presidential Chair in Leadership Candace S. Johnson, PhD. “The contributions of Drs. Robert Fenstermaker and Michael Ciesielski, the Roswell Park lab and research teams, and a whole community of supporters who made this progress possible are bringing hope to patients near and far.”

Dr. Robert Fenstermaker

“Glioblastoma remains one of those cancers that’s extremely difficult to treat, and treatments have improved only modestly in the last few decades,” says Robert Fenstermaker, MD, Chair of Neurosurgery at Roswell Park, co-creator of SurVaxM and national Principal Investigator on the SURVIVE trial. “There’s a real need for better treatments for patients with this disease, and thanks to the support of our colleagues and community we are grateful to see our work with SurVaxM advance to this exciting stage.”

Work to develop the vaccine was enabled by donations from numerous individuals and corporations to the Roswell Park Alliance Foundation, including support for events like the Ride for Roswell.

SurVaxM is currently available to patients with newly diagnosed glioblastoma brain cancer through the randomized, blinded, placebo-controlled Phase 2b SURVIVE clinical trial (NCT05163080). Approximately 60% of an anticipated 270 patients have been enrolled on the study, which is currently recruiting new patients at 11 cancer centers nationwide: Roswell Park, where SurVaxM originated, as well as Miami Cancer Institute, Cleveland Clinic, Dana-Farber Cancer Institute, Overlook Medical Center, Norton Cancer Institute, Fred Hutchinson Cancer Center, Texas Oncology, New York University, Northwell Health and University of California–San Francisco. 

Dr. Michael Ciesielski

“Fast Track Designation is a key component in our journey to help patients with glioblastoma to live longer,” says Michael Ciesielski, PhD, co-creator of SurVaxM, Assistant Professor of Neurosurgery at Roswell Park and CEO of MimiVax.

Positive final data from the previous phase 2a study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM), published in the Journal of Clinical Oncology, reported that 51% of patients receiving SurVaxM survived at least 2 years, and 41% survived at least 3 years. The median overall survival of 25.9 months with nGBM in the study were considerably higher than would be expected with standard therapy alone. 

Fast Track is a process designated to facilitate the development and expedite the review of drugs to treat serious medical conditions and fulfill unmet medical need. Significant benefits of FTD include:

• Enhanced access to the FDA including opportunities for more frequent meetings and direct consultation throughout the remaining development of SurVaxM.
• Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval.
• 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.

MimiVax was formed more than a decade ago as a spinoff from Roswell Park to develop and commercialize SurVaxM. For more information on MimiVax, visit www.mimivax.com.

SurVaxM is also being evaluated in early-phase studies of adult patients with some neuroendocrine tumors and in pediatric patients with some types of brain tumors, and is also being assessed in adults with multiple myeloma.

For more information about the phase 2B SURVIVE study or other clinical trials available at Roswell Park, call 1-800-ROSWELL (1-800-767-9355) or send an e-mail to AskRoswell@Roswellpark.org. See more information and resources related to SurVaxM at roswellpark.org/survaxm.

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From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email ASKRoswell@RoswellPark.org.