Tmunity, a clinical stage biotherapeutics company, said it is abandoning its lead program after two trial participants died due to neurotoxicity, Endpoints News reported June 2.
Tmunity was founded in 2015 by Oz Azam, MD, and Carl June, MD, the famed immunologist who pioneered T-cell therapies for cancer. Both physicians worked on CAR-T cell initiatives at Novartis before creating Tmunity, a spinout from the Philadelphia-based University of Pennsylvania.
Drs. Azam and June told Endpoints News they had to scrap their lead program for prostate cancer after two trial participants died. The halt was voluntary at first, but the FDA later told the company to stop its clinical trial.
“I think the bottom line is we’re finding that toxicity is different in liquid tumors like leukemia and myeloma from solid tumors like pancreatic cancer or prostate cancer," Dr. June said. "I think it’s what is called macrophage activation syndrome, which is related to cytokine storms or [cytokine release syndrome], it’s probably caused by different cytokines."
When Dr. June and other researchers were developing CAR-T cell therapies for blood cancers, cytokine release syndrome caused patient deaths. The issue was resolved, and Drs. June and Azam believe the same can be done for the neurotoxic threat posed to T-cell therapies for solid tumors.
Tmunity has put its plans to file for an IPO on hold while it restrategizes its clinical development, according to Endpoints News. Dr. Azam said the company will focus on spreading the word about the safety issue that derailed its trial and caused participant deaths, as other companies studying CAR-T cell therapies for solid tumors need to be aware of the issue.