Two doctors at work on a brain cancer immunotherapy drug designed at Roswell Park Comprehensive Cancer Center reached another milestone Wednesday in announcing that SurVaxM will head into a larger clinical treatment trial with more financial muscle.
Drs. Robert Fenstermaker and Michael Ciesielski – who developed the therapy to fight glioblastoma – will get help from a Chinese drug manufacturer to continue to develop SurVaxM and, if studies continue to show success, bring it to market.
The doctors in 2012 created MimiVax LLC to bring cancer treatments developed in Buffalo to wider use. The company has entered into a China-exclusive SurVaxM licensing agreement with Shanghai Fosun Pharmaceutical Industrial Development Co.
Fosun Pharma agreed to pay $10 million upfront so MimiVax can conduct phase II clinical trials to further gauge the effectiveness of the immunotherapy drug. The company also is eligible to receive $28 million as drug development continues and $110 million if the drug goes to market — a step that would require even further clinical trials in a development process that will take years to complete.
SurVaxM, made in the United States, is designed to stimulate the immune system to kill tumor cells that contain survivin, a protein that helps cancer cells resist conventional treatments. The protein also is present other cancers, including multiple myeloma, melanoma, kidney and breast tumors.
Early testing in brain tumors has been encouraging. A limited phase II study in 63 patients last year showed that 93.5% patients treated with SurVaxM were alive one year after diagnosis, compared to a historical rate of 65%.
“Immunotherapies are changing the way we treat many cancers, but none of the FDA-approved immunotherapies are an option for patients with glioblastoma,” said Fenstermaker, chairman of neurosurgery at Roswell Park and chief medical officer of MimiVax, in a news release. “The approved treatment options we do have for patients with the disease remain quite limited both in number and in effectiveness.”
The doctors said the new agreement will help researchers advance to larger randomized drug trials next year in China and the U.S.