Pre-Clinical Studies Demonstrate Prevention of Infection, Recurrent Lesions and Viral Shedding
ANN ARBOR, Mich., (March 6, 2017) – NanoBio Corporation today announced that it has been awarded a two-year Phase II Small Business Research Innovation (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for the development of an intranasal nanoemulsion (NE) adjuvanted vaccine for the prevention of genital herpes. The grant will fund up to $1.5 million of critical preclinical research and process development activities, including the completion of a pre-IND meeting with the U.S. Food and Drug Administration.
Genital herpes is a sexually transmitted disease most commonly caused by the herpes simplex virus-2 (HSV-2). Infections are lifelong and are often asymptomatic facilitating the spread of the disease amongst sexual partners and from mother to child during birth. Genital herpes is also associated with an increased risk of HIV acquisition. The disease is widespread in both developed and underdeveloped countries, and is a global health priority. According to estimates from the Centers for Disease Control and Prevention (CDC), over 24 million people in the United States are infected with HSV-2 and there are 776,000 new infections each year. Approximately one out of every six people aged 14 to 49 years has an HSV-2 infection. Currently, there are no approved vaccines to prevent or treat the disease.
Under NIAID’s suite of preclinical services, researchers at the Cincinnati Children’s Hospital Medical Center previously tested NanoBio’s intranasal vaccine in several guinea pig challenge studies. “NanoBio’s intranasal vaccine is one of the only vaccine candidates we’ve studied that has shown efficacy in both the prophylactic and the therapeutic animal models,” said Dr. David I. Bernstein, Professor of Pediatrics at Cincinnati Children’s Hospital Medical Center. “Based on our data with this unique approach, we look forward to seeing the intranasal NE vaccine progress to human clinical studies.”
In the prophylactic guinea pig study, the intranasal NE HSV-2 vaccine prevented infection and viral latency in 92 percent of animals vaccinated, versus 8 percent in a no treatment arm. In a separate therapeutic study, animals with recurrent HSV-2 infection were vaccinated with the intranasal NE vaccine. During the post-vaccination observation period, the NE HSV2 vaccine reduced recurrent lesions and viral shedding by more than 50 percent as compared to animals that received no treatment. No adverse events were observed in any of the animals that received the NE vaccine.
“The Phase II SBIR grant is a testament to the potential of NanoBio’s intranasal NE vaccine for genital herpes. The funding enables the next step in the development research process,” said Dr. Ali Fattom, Senior Vice President of Vaccine Research and Development, NanoBio. “Throughout the past several years, we have consistently observed that our intranasal vaccine elicits both a serum and a mucosal immune response in animals. This differentiates our program from the many intramuscular HSV-2 vaccines in development. NanoBio’s intranasal NE vaccine provides protection both systemically and in mucosal tissues at the port of entry for the herpes virus. Based on pre-clinical data to date, we believe this first line of defense is essential to adequately protect against genital herpes.”
Headquartered in Ann Arbor, Michigan, NanoBio® Corporation is a privately-held biopharmaceutical company focused on developing and commercializing vaccines and anti-infective treatments derived from its patented NanoStat® technology platform. The company’s NanoStat® vaccine technology employs a novel oil-in-water nanoemulsion (NE) that can incorporate, deliver and adjuvant multiple antigen types. The NE adjuvant is effective when administered via intranasal or intramuscular vaccination. When applied intranasally, NE vaccines elicit both mucosal and systemic immunity.
NanoBio is currently developing NE vaccines for several respiratory and sexually transmitted diseases, including RSV, pertussis, pandemic influenza, anthrax, prophylactic and therapeutic HSV-2, and chlamydia.