NanoBio's Intranasal RSV Vaccine Induces Robust Immunity in Animals

NanoBio® Corporation announced today that data from recent animal studies of its NanoStat®-based intranasal respiratory syncytial virus (RSV) vaccine have been published in PLoS One, an international peer-reviewed online publication. The studies were conducted at the University of Michigan Medical School and Seattle Children's Research Institute, and demonstrate that NanoBio's RSV vaccine induces robust protective immunity in mice without eliciting the enhanced respiratory disease that has caused other RSV vaccine candidates to fail.

RSV is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. It is the number one cause of childhood hospitalization both in the United States and around the world. Nearly all children are infected with the virus at least once by the age of 2-3 years. The disease is particularly dangerous for premature babies, children with other health conditions and the elderly. Many children develop pulmonary disease and/or asthma from RSV that persists throughout adult life making them susceptible to re-infection. Currently, there are no approved vaccines for RSV.

Ali I. Fattom, Ph.D., Senior Vice President of Vaccine Research and Development at NanoBio, stated, "In these studies, we observed the NanoStat-based RSV vaccine to induce robust immunity while decreasing mucus production and increasing viral clearance without Th2-mediated immune potentiation. These attributes have not been seen with prior vaccine candidates, and indicate significant potential for the development of the first safe and effective RSV vaccine."

Dr. Fattom added, "Given the promising results from these studies, we are now on an aggressive development timeline for RSV. Our early research in other animal species mirrors what we have seen in mice. We have therefore recently procured a novel GMP antigen source for RSV, which will enable future testing of the NanoStat-based vaccine in a Phase 1 human study."

About NanoBio's Vaccine Platform

NanoBio's nanoemulsion-based, intranasal vaccines have elicited robust immune responses in animals vaccinated against seasonal and pandemic influenza, hepatitis B, RSV, HIV, pneumococcus, anthrax, smallpox and other diseases. The company's NanoStat adjuvant platform technology has demonstrated numerous potential advantages over traditional vaccines, including: the ability to generate robust mucosal, systemic and cellular immunity; antigen-sparing qualities; cross-protection against strains not contained in the vaccine; ability to adjuvant multiple antigen types without inducing inflammation; thermally stabilizing the vaccine; and removing the need for needles.

NanoBio's lead vaccine candidate, NB-1008, is a seasonal influenza vaccine administered intranasally. In a recently completed Phase 1 clinical study, NB-1008 was well-tolerated and elicited both mucosal and systemic immune responses following a single intranasal vaccination in a study of 199 healthy adults.

About NanoBio

NanoBio® Corporation 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, acne, cystic fibrosis and a broad platform of intranasal vaccines. The company's headquarters and laboratory facilities are located in Ann Arbor, Michigan.