NanoBio to highlight prophylactic NE HSV-2 vaccine candidate at The Keystone Symposia Conference

NanoBio CorporationOct 9 2014

NanoBio Corporation today announced that the company will present data at The Keystone Symposia Conference, The Modes of Action of Vaccine Adjuvants, in Seattle on October 12, 2014. The Company's presentation will highlight the advantages of its nanoemulsion (NE) adjuvant in the development of a prophylactic genital herpes vaccine that induces protection by eliciting both systemic and mucosal immune responses.

Genital herpes is a sexually transmitted disease most commonly caused by the herpes simplex virus-2 (HSV-2). Infections are lifelong and 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. Currently, there are no approved vaccines for HSV-2.

Funded by the National Institute of Allergy and Infectious Diseases' Division of Microbiology and Infectious Diseases, NanoBio is studying the potential of an intranasal NE-adjuvanted glycoprotein vaccine in a guinea pig challenge model. During the Symposia, data will be presented demonstrating the potential advantages of NanoBio's prophylactic NE HSV-2 vaccine candidate, including:

• The prevention of infection and viral latency, as measured by the absence of viral infection of the dorsal root ganglia in 11 of 12 animals vaccinated with the NE vaccine.
• The ability to induce enhanced protection against chronic recurrence of herpes lesions as compared to the intramuscular MPL/Alum gD2 vaccine (p=0.01). 83% of animals vaccinated with the intranasal NE vaccine were completely lesion-free during the seven week chronic phase, as compared to 58% of animals immunized with an intramuscular MPL/Alum gD2 vaccine.
• The achievement of enhanced protection despite eliciting lower systemic antibodies than the intramuscular MPL/Alum gD2 vaccine, demonstrating the benefit of the mucosal and cellular immune responses elicited by the intranasal NE vaccine.

Genital herpes is a serious disease that causes painful sores, increased potential of contracting HIV, psychological damage and can be passed from a mother during childbirth with potentially fatal implications. The disease is transmitted primarily through sexual contact, therefore developing a vaccine that induces both mucosal and systemic immunity is critical to minimizing spread of the disease. Recent clinical studies of intramuscular vaccine candidates have failed to demonstrate adequate protection against HSV-2 infection, likely due to the inability to protect mucosal pathways from HSV pathogens.

"Genital herpes is a serious health issue globally. Once infected, the virus establishes latency in the nervous system causing chronic recurrences and the potential for transmission through sexual contact," said Dr. Lawrence Stanberry, Reuben S. Carpentier Professor and Chairman of the Department of Pediatrics at the College of Physicians and Surgeons at Columbia University, and Pediatrician-in-Chief of the Morgan Stanley Children's Hospital of New York Presbyterian. "Historically, vaccines have focused on preventing infection and/or recurrence by boosting systemic immunity. To date, this approach has not proved to be effective. HSV-2 enters the body through the genital mucosa. Therefore, a vaccine that induces both systemic and mucosal immune responses has significant potential to impact the spread of this disease."

NanoBio's NanoStat® technology platform employs a novel oil-in-water nanoemulsion 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 mucosal immunity as well as systemic immunity.