Drug developed at University of Montana moves to cancer patient trials

MISSOULA – A compound discovered by the University of Montana Center for Translational Medicine has started Phase I clinical trials with cancer patients. The center’s partner in the effort is Inimmune Corp., a Missoula-based biotechnology company.

Jay Evans, a UM researcher and director of the center, said reaching human clinical trials is a milestone for the University and highlights the importance of research at UM.

“Since we joined UM in 2016, it’s been our goal to advance UM research discoveries to treatments that can be safely used in people,” Dr. Evans said. “The transition from pre-clinical to clinical stage of drug development is challenging, and it’s been great to partner with a local Missoula company and advance a university-discovered technology to human clinical trials.”

The first in-human trial of the drug, INI-4001, will take place in Australia. The compound will be delivered via IV to patients with advanced solid tumors. Evans said INI-4001 stimulated the immune system to fight cancer in previous studies using animal models. The first human trials are an ascending-dose study, meaning the dosage starts low and is slowly increased to evaluate safety and tolerability.

“INI-4001 is a novel compound that may benefit patients with many different types of cancer, without the usual side effects of traditional cancer therapy,” said Dr. Jon Ruckle, Inimmune’s chief medical officer. “The start of this clinical trial in cancer subjects is a huge milestone, and is a tangible demonstration of the synergy between UM and Inimmune.”

INI-4001 initially was designed at the University as an adjuvant, a substance to boost the effectiveness of vaccines. Now it will be tested for its ability as a potential tool to fight cancer.

Inimmune is a private biotech company focused on the discovery and development of immunotherapies, vaccines and vaccine adjuvants. Inimmune is housed in MonTEC, UM’s Missoula-based business incubator. Its partner, the Center for Translational Medicine, works to help students and employees move UM research from the lab to the real world.

Evans said INI-4001 was developed with support from UM graduate and undergraduate students working in campus labs.

“UM students work in our labs every day making new discoveries, they are integral to everything we do,” he said. “The Center for Translational Medicine at UM prepares students for careers in biotechnology, which is ideal for both UM students and Inimmune, which hires well-trained UM graduates from the CTM program.”

Together, the UM center and Inimmune employ about 70 people on campus and across the river at MonTEC. CTM offers one of the largest university-based academic research teams for vaccine discovery and development in the U.S., and the center was a major reason UM landed on the 2020 list titled “Best Universities Solving the Coronavirus Pandemic.”