Buffalo-based MimiVax has raised millions as it works toward commercialization of its cancer immunotherapy drug.
The spin-off from Roswell Park Comprehensive Cancer Center recently raised a nearly $5.8 million convertible debt round to continue its phase 2B clinical trial for SurVaxM, its cancer immunotherapy drug. The round is expected to close by the end of August, according to CEO and co-founder Dr. Michael Ciesielski.
“Our drug and our company really spawned off of a Buffalo community effort,” he said. “We started with a funds donation from Roswell Park and … the Buffalo community.”
The Roswell Park Alliance Foundation also contributed to the funds, he added.
The trial, which started recruiting in Q1 2022, is for newly diagnosed glioblastoma patients. Glioblastoma is a fast-growing tumor that forms in the brain or spinal cord.
The trial is expected to continue for another year and has about 250 patient participants from 11 different cancer centers across the U.S. Roswell is the central site.
When the trial concludes, MimiVax will get data from the study and discuss options with the U.S. Food and Drug Administration to approve the drug.
The FDA issued last year fast track approvals for the Buffalo company to expedite the drug review process by giving the company enhanced access to FDA officials in the development of SurVaxM.
“If everything works out really well for us and we have good data for Phase 2B, we could be eligible for accelerated approvals, which would allow us to market the drug after Phase 2B,” Ciesielski said.
The business also recently got expanded orphan drug designation from the FDA for SurVaxM. The special designation is only awarded for rare conditions with patient populations of fewer than 200,000. The designation allows SurVaxM to be used as treatment not only for just adult glioblastoma but for a broader category of cancerous brain tumors and any malignant glioma in children or adults.
MimiVax, based on the Roswell campus, first received orphan drug status for SurVaxM in August 2017, five years after the company spun out on its own. The drug was invented at Roswell Park by Ciesielski and Dr. Robert Fenstermaker, Roswell Park’s neurosurgery chairman.
The company, which has a team of about four, has raised a total of about $23 million, not including the most recent $5.8 million round, from investment and partnering fees.
MimiVax is the seventh local company to acknowledge a private, growth-oriented round of funding this year. The list includes Circular.eco ($100,000), Edenesque ($175,000), TeleSafety ($230,000), SelectFI ($750,000), Top Seedz ($750,000), MimiVax ($5.8 million) and CleanFiber ($28 million).
