Vaccine protects both systemically and in mucosal tissues at the port of entry for the virus.
NanoBio Corporation was awarded a 2-year phase 2 Small Business Research Innovation (SBIR) grant for the development of an intranasal nanoemulsion (NE) adjuvant vaccine for genital herpes prevention.
The grant was given by the National Institute of Allergy and Infectious Diseases (NIAID) and will fund up to $1.5 million of critical preclinical research and development activities, including the completion of a pre-IND meeting with the FDA, according to a companypress release.
Genital herpes is most commonly caused by the herpes simplex virus-2 (HSV-2), and infections are lifelong. Thevirus is often asymptomaticcausing transmission between partners and mother-to-child transmission. Furthermore, studies have shown an association between genital herpes and the increased risk of HIV acquisition.
Individuals with HIV and herpes are more likely to pass on HIV because the presence of herpes increases HIV viral load, according to NAM. Furthermore, HIV-negative individuals with herpes blisters have an increased vulnerability to HIV infection.
The grant was based on experiments using NanoBio’s intranasal NE vaccine in several guinea pig challenge studies, according to the release.
“NanoBio’s intranasal vaccine is one of the only vaccine candidates we’ve studies that has shown efficacy in both the prophylactic and the therapeutic animal models,” investigator Dr David Bernstein, professor of pediatrics at Cincinnati Children’s Hospital Medical Center, said in the release. “Based on our data with this unique approach, we look forward to seeing the intranasal NE vaccine progress to human clinical studies.”
During the prophylactic guinea pig study, the investigators found that the intranasal NE HSV-2 vaccine prevented infection and viral latency in 92% of animals vaccinated, compared with 8% who received no treatment (control).
A separate therapeutic study, animals with recurrent HSV-2 infection were vaccinated with the intranasal NE vaccine. During the post-vaccination observation period, the investigators found that the vaccine reduced recurrent lesions and viral shedding by more than 50% compared with the control arm. There were no adverse events observed in any of the animals that were administered the NE HSV-2 vaccine.
“The phase 2 SBIR grant is a testament to the potential of NanoBio’s intranasal NE vaccine for genital herpes,” Dr Ali Fattom, senior vice president of vaccine research and development at NanoBio, said in the company release. “The funding enables the next step in the development research process.
“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 preclinical data to date, we believe the first line of defense is essential to adequately protect against genital herpes.”
The CDC estimates more than 24 million individuals in the United States are infected with HSV-2, with 776,000 new infections each year. Currently, there are no approved vaccinations to prevent the disease.