NanoBio® Corporation today announced an initiative to develop an intranasal vaccine for the treatment of hepatitis B (HBV). NanoBio and the University of Michigan's, Michigan Nanotechnology Institute for Medicine and Biological Sciences received funding through a Phase 1 Technology Transfer (STTR) award by the National Institutes of Health (NIH), to evaluate a potential therapeutic intranasal vaccine for the treatment of hepatitis B in patients. This development program represents the first of several potential therapeutic vaccines in a significant extension of NanoBio's vaccine platform.
“Currently available HBV vaccines are effective prophylactics, but lack therapeutic properties for those that are already infected”
Hepatitis B is an infection of the liver caused by the HBV virus. HBV is the most common cause of chronic viral liver disease worldwide. More than 370 million people are chronically infected with hepatitis B, leading to nearly one million deaths annually as a result of cirrhosis, and liver failure. HBV is transferred via bodily fluids and blood, and is commonly spread through sexual intercourse and intravenous drug use. Today, vaccinations are routinely given to infants to prevent infection contributing to lower rates of incidence in recent years. However, for patients previously infected, recurring infection is a concern that cannot be mitigated with existing vaccines.
"Currently available HBV vaccines are effective prophylactics, but lack therapeutic properties for those that are already infected," said James R. Baker, MD, CEO and founder of NanoBio. "This new intranasal vaccine would have great value as a treatment to reduce the risk of HBV associated liver diseases and deaths globally. The vaccine is also highly stable at room temperature enabling storage without refrigeration, a factor of great importance in the developing world."
Through this project, NanoBio and University of Michigan teams will demonstrate in animals the capabilities of a nanoemulsion-based HBV vaccine to safely induce immune responses in the presence of confounding factors such as kidney failure. This research is especially important as individuals with kidney function deficiencies are at high risk for complications of HBV infection when compared to normal individuals.
After successful completion of the preclinical studies funded by this STTR, NanoBio plans to conduct a FDA-approved Phase 1 clinical trial to evaluate safety, dose range, immunogenicity and preliminary efficacy against chronic HBV in humans with kidney failure.
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