NanoBio Corp. today announced a licensing agreement with the University of Michigan that provides NanoBio with rights to an antigen that has been shown to prevent urinary tract infections following intranasal vaccination. 

Through the agreement, Ann Arbor-based NanoBio gains access to an antigen that University of Michigan researchers have shown can prevent recurring UTIs by eliminating E. coli bacteria in the urinary tract. 

The associated study involved immunizing mice intranasally with the antigen coupled with an adjuvant that is not approved for human use.  To continue progressing toward a resolution for the millions of women who suffer from painful and often recurrent UTIs, a safe and effective vaccine is necessary.

NanoBio plans to pair the UTI antigen with the company’s nanoemulsion-based NanoStat adjuvant technology as the intranasal delivery mechanism for the vaccine. Once it is proven that the nanoemulsion-based vaccine achieves similar success in mice, it is anticipated that a human clinical trial will follow. The NanoStat adjuvant technology has been proven safe and effective in a previous clinical study of NanoBio’s intranasal influenza vaccine.

According to the National Institute of Diabetes and Digestive and Kidney Diseases, 53 percent of women suffer from UTIs annually and nearly 500,000 are hospitalized as a result. Approximately one in five women who experience a UTI will have recurrent UTIs. Generally, UTIs are treated with a course of antibiotics to clear the infection; however, a clinically proven therapy for preventing UTIs is not available today.  UTIs led to more than $3.5 billion in evaluation and treatment related costs in 2000.

“E. coli causes nearly 90 percent of all UTIs,” said Marry Mobley, Frederick G. Novy Collegiate Professor of microbiology and immunology and chair and professor in the department of microbiology and immunology at the University of Michigan. “It is a common bacterium and is frequently treated with antibiotics, which has led to the emergence of drug resistant strains that are difficult to treat. We previously anticipated at least 10 years of further development of the vaccine before reaching commercialization; however, partnering with NanoBio and using their NanoStat technology will significantly accelerate the development of this long-awaited vaccine.”

Said Ali I. Fattom, senior vice president of vaccine research and development at NanoBio: “Several attempts at developing a UTI vaccine have been unsuccessful as antibodies from blood have limited access to mucosal surfaces such as the urinary tract where these infections occur. We are confident the combination of effective UTI antigens with NanoBio’s NanoStat adjuvant platform technology will result in strong mucosal immunity that can prevent these infections. We have recently shown in our influenza vaccine clinical studies that the NanoStat adjuvant is safe and mucosal immunity is enhanced significantly. These findings will facilitate the development of a safe and effective vaccine against mucosa-associated infections in the urinary tract.”

NanoBio is a privately held biopharmaceutical company focused on developing and commercializing dermatological products, anti-infective treatments and intranasal vaccines derived from its patented NanoStat technology platform. The company’s lead product candidates are treatments for herpes labialis (licensed to GSK in the U.S. and Canada), onychomycosis (nail fungus), acne, cystic fibrosis and a broad platform of intranasal vaccines.

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