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A Miller School Licensing Success Story: ZyVersa Therapeutics’ Drug Development Program

By bringing two leading-edge research programs together with an experienced pharmaceutical entrepreneur, U Innovation at the University of Miami Miller School of Medicine is facilitating the development of new drugs for multiple indications with a potential for financial payoff for long-term investors.

“One of the key missions of the Miller School of Medicine is to accelerate the development of new treatments for our patients,” said Norma Kenyon, Ph.D., UM’s vice provost for innovation and the Miller School’s chief innovation officer. “ZyVersa Therapeutics is a great example of that bench-to-bedside process.”

Dr. Alessia Fornoni

“I was introduced to the University of Miami in 2014, just after I had taken a biomedical company public,” said 38-year pharmaceutical veteran Stephen C. Glover, co-founder, CEO and president of ZyVersa Therapeutics in Weston. “Many people in the industry didn’t realize the excellence of the research at the Miller School.” After talking with Dr. Kenyon, Glover became a UM entrepreneur in residence and advisor to U Innovation, through the Wallace H. Coulter Center for Translational Research and the UM Office of Technology Transfer.

“Today, our university boasts more than 80 faculty-founded startups, and is licensing about 30 faculty inventions a year from software to devices to therapeutic endeavors,” said Dr. Kenyon. “Our team provides support for their commercial development since it takes a long time to get to an actual product that can really change people’s lives.”

An innovative approach to kidney disease

Drawing on his background in kidney disease and inflammation, Glover recognized the importance of the studies on renal lipids being done by Alessia Fornoni, M.D., Ph.D., professor of medicine, chief of the Katz Family Division of Nephrology and Hypertension, and director of the Peggy and Harold Katz Family Drug Discovery Center.

“Although cholesterol is critical for healthy cells, in chronic kidney diseases excess cholesterol accumulates in the filtration system, resulting in protein spillage into the urine,” Dr. Fornoni said. “I began this research in 2009, and it immediately became clear that fatty cells behaved very differently from normal cells. We were able to repurpose an existing drug that was able to prevent kidney failure in mice by clearing the lipids.”

Glover recognized the potential of the research of Dr. Fornoni and her longstanding collaborator Sandra Merscher, Ph.D., research associate professor. He obtained a license through the Office of Technology Transfer (OTT) in 2014, and began the long process of developing a potential new therapy. “No one else was looking at renal lipids like Dr. Fornoni, and I saw there could well be commercial applications down the road,” Glover said.

Since then, Dr. Fornoni has helped ZyVersa develop VAR 200, a drug that can remove excess cholesterol, protect against structural damage, and preserve the kidneys’ function in experimental models of several kidney diseases. A Phase IIa clinical trial is scheduled this year for patients with focal segmental glomerulosclerosis (FSGS), a rare kidney disease with very limited therapeutic options. “VAR 200 has the potential to treat numerous other kidney diseases, including Alport syndrome and diabetic kidney disease,” said Dr. Fornoni.

A new strategy for treating inflammation

For the past 15 years, Robert W. Keane, Ph.D., professor of physiology and biophysics, neurological surgery, and microbiology and immunology, has been studying inflammasomes, a group of protein complexes that stimulate inflammation as a defense against pathogens and cellular stress. “While inflammasomes play a crucial role in the body’s immune system, they can cause chronic inflammation unless deactivated at the appropriate time,” said Dr. Keane.

Dr. Robert Keane

He first looked at the expression of inflammasomes in laboratory models of spinal cord injuries. With support from the Coulter Center, he and his colleagues, Drs. Juan Pablo de Rivero Vaccari, W. Dalton Dietrich, and Helen M. Bramlett, developed a monoclonal antibody that improved laboratory outcomes for spinal cord and traumatic brain injuries. “We then applied for a fast-track phase II grant through the National Institutes of Health that allowed us to make a manufacturing cell line,” Dr. Keane said. “In 2015, I met Steve Glover on one of his campus visits. He realized the potential of this work, and worked with the OTT to license the intellectual property from UM.”

ZyVersa is now developing IC 100, a new humanized monoclonal antibody that inhibits inflammasomes in order to block the inflammatory cascade. “It has numerous potential clinical applications,” said Glover. For instance, chronic inflammation has been linked to kidney and heart disease, diabetes, arthritis, lupus, Alzheimer’s disease, and other chronic conditions. “While the renal lipid and inflammasome technologies are different, there are many areas of overlap in their disease indications,” said Glover. “Now we want to take the product opportunities to the next stage of their development.”

Reflecting on the difficult challenge of turning UM discoveries into potential commercial products, Dr. Fornoni said, “Chronic kidney disease is the Number 9 cause of death across the globe, and ZyVersa Therapeutics could deliver the first new therapy in many years. Visionary entrepreneurs like Steve can do a tremendous service to patients here and around the world.”





Tags: Dr. Alessia Fornoni, Dr. Norma Kenyon, Dr. Robert Keane, U Innovation, ZyVersa