Clinical Trial Underway To Test Plant-Based Gel’s Power To Boost Anti-Tumor Drugs

James Moon’s work has shown that a new plant-based fiber formulation may dramatically boost the tumor-fighting power of anti-cancer drugs. Now, he is collaborating with Michigan Medicine colleagues on a clinical trial to see if it can help patients fight kidney tumors.

A class of drugs called immune checkpoint blockers (ICBs) can spur the immune system to attack tumors, but they work in only 10 to 30 percent of patients and can cause adverse effects. Moon, Chair and the J. G. Searle Professor of Pharmaceutical Sciences at the College of Pharmacy, has shown that when ICBs are paired with inulin, a plant-based fiber and prebiotic, they are two to three times more effective at shrinking tumors in animal models. 

The clinical trial, called ICON, will recruit 48 patients with renal cancer. Those admitted to the trial will take inulin formulated as a yogurt-like gel daily, along with their ICB treatment. Follow-up will monitor how the combined treatment affects the tumors, measure changes in the gut microbiome, and track side effects, Moon says.

“We know that the gut microbiome plays a role in the body’s immune response. Including more fiber in the diet can improve the microbiome, but most people don’t eat enough fiber,” he notes. He began working with inulin as a safe, natural way to enrich the microbiome in the gastrointestinal tract and spur a more active immune response. His research team has found that formulating the inulin as a gel improves its pharmacokinetic properties and efficacy.

Early pre-clinical studies showed that the team’s inulin gel improved T-cell memory responses and enhanced the anti-tumor activity of the checkpoint inhibitor α-PD-1. “We hope that inulin gel will have the same effect in humans, increasing the efficacy of the drug without increasing toxicity,” said ICON principal investigator Ulka Vaishampayan, MD, FASCO, the Beverly S Mitchell Research Professor of Cancer Research at Michigan Medicine.

If inulin gel is effective in the renal cancer trial, it could open the potential to enhance ICB treatment for other tumor types. Inulin gel may also be useful for managing other conditions associated with an unhealthy gut microbiome, including inflammatory bowel disease and immune, inflammatory, and autoimmune conditions.

Moon is in the process of forming a company that could bring the inulin gel format to market as a dietary supplement for broader consumer use as well.