Cancer drug developed at UM is now being clinically tested on humans

MISSOULA, Mont. — A cancer treatment drug (INI-4001) developed by the University of Montana in collaboration with Inimmune Corp. is about to enter Phase I clinical trials in humans.

In previous animal studies, the compound stimulated the immune system to fight cancer.

INI-4001 is administered intravenously to cancer patients with advanced solid tumors.

Human trials of the drug are being conducted in Australia.

The University of Montana sent out the following:

A compound discovered by the University of Montana's Center for Translational Medicine has begun Phase I clinical testing in 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 conducting human clinical trials is a milestone for the university and underscores the importance of research at UM.

“Since joining UM in 2016, our goal has been to translate UM's research into treatments that can be safely used in humans,” said Dr. Evans. “Moving from the preclinical to clinical phases of drug development is challenging, and it has been great to partner with a local Missoula company and move a technology discovered at the university into human clinical trials.”

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

“INI-4001 is a novel compound that has the potential to help patients with many different types of cancer without the common side effects of traditional cancer therapy,” said Dr. Jon Ruckle, Chief Medical Officer of Inimmune. “The initiation of this clinical trial in cancer patients is a major milestone and tangible evidence of the synergy between UM and Inimmune.”

INI-4001 was originally developed at the university as an adjuvant, a substance designed to increase the effectiveness of vaccines, and is now being tested for its suitability as a potential cancer-fighting agent.

Inimmune is a private biotechnology company focused on the discovery and development of immunotherapies, vaccines and vaccine adjuvants. Inimmune is housed in MonTEC, UM's Missoula-based incubator. Its partner, the Center for Translational Medicine, works to help students and collaborators translate UM's research from the lab to practice.

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

“UM students work in our labs every day making new discoveries. They are an integral part of 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 big reason UM landed on the 2020 list titled “Best Universities to Solve the Coronavirus Pandemic.”