Innovate Biopharmaceuticals Drug Candidate To Be Used In Cancer Study

You could call it a cancer gut check. 

Innovate Biopharmaceuticals, a Raleigh clinical-stage biotechnology company, will partner with a French oncology researcher to find out if gut microbes influence the effectiveness of certain cancer treatments. 

Innovate develops medicines for autoimmune and inflammatory diseases. Its first drug candidate, larazotide acetate, is a therapy for celiac disease.

The company will work with Laurence Zitvogel, MD, Ph.D., scientific director of the Immuno-Oncology Program at Institut Gustave Roussy in Villejuif, France. Institut Gustave Roussy is one of the world’s leading comprehensive cancer centers. Dr. Zitvogel and other researchers have found that resistance to checkpoint inhibitor immunotherapies, such as CTLA-4 and PD-1, may be the result of abnormal gut microbial composition. 

She and her team will use larazotide acetate -- which decreases intestinal permeability -- to investigate the possible connection between intestinal microbial imbalance and the body’s response to these therapies. They want to better understand how checkpoint inhibitors react when bacterial antigens and toxins are blocked from interfering with the body’s immune system.

“We are pleased to work with Professor Zitvogel to understand how larazotide’s re-normalization of intestinal permeability could affect the immune checkpoint response in tumor models,” said Innovate CEO Sandeep Laumas, M.D. “We also want to help clarify the complex interaction of the gut microbiome with the immune system in cancer.”

Zitvogel said the collaboration will help clarify “the delicate interactions between the intestinal epithelial cells, the microbiome and the immune system in the gut and their consequences on tumor immunosurveillance. I’m excited to study how larazotide could normalize these interactions in advanced cancer patients to optimize their therapies,” she added.

Larazotide acetate could become the first approved medicine to treat celiac disease. It belongs to a new class of drugs called tight junction regulators. They reduce permeability of the intestine, also known as “leaky gut,” a widely recognized entry point for multiple autoimmune disorders. Tight junctions are complex protein structures located between epithelial cells in the bowel that regulate the absorbency of the intestinal barrier. They should stay closed except to shed dead cells. 

In patients with celiac disease, the presence of gluten -- a protein in certain food grains -- causes these tight junctions to remain open, starting an inflammatory response within the bowel that can eventually destroy the inner lining of the small intestine. This disorder affects 3 million people in the United States and close to 15 million worldwide.

Larazotide has received Fast Track status from the U.S. Food and Drug Administration and will soon be the first drug in its class to enter a Phase 3 trial for celiac disease.

Innovate, which was founded in 2012, is publicly traded on the NASDAQ stock exchange under the ticker symbol INNT.