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Posted: April 21, 2009
NanoBio Initiates FDA Approved Clinical Trial for Adjuvanted Intranasal Influenza Vaccine
(Nanowerk News) NanoBio has announced that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for the Phase 1 clinical study of NB-1008, a seasonal influenza vaccine administered via a nasal dropper.
NB-1008 uses a novel nanoemulsion-based adjuvant to achieve a robust immune response using only a small fraction of the antigen required by currently available injectable vaccines. In numerous animal studies, NB-1008 has demonstrated robust mucosal, systemic and cellular immunity without inflammation or safety concerns.
The underlying technology for NB-1008 is NanoBio's NanoStat platform, which employs a nanoemulsion that is created through a proprietary manufacturing process. The nanoemulsion is uniquely capable of permeating the nasal mucosa, where it can load vaccine antigen into immune-presenting cells. These cells then carry the antigen to areas of the body that initiate an immune response, including the lymph nodes, thymus and spleen. NanoBio is in various stages of preclinical development for numerous other nanoemulsion-adjuvanted vaccines, including hepatitis B, pandemic influenza, RSV, HIV, pneumococcal, cancer, anthrax and smallpox.
"The initiation of this study represents a significant accomplishment for NanoBio, and enormous potential to fundamentally change vaccine development," said James R. Baker, Jr., MD, NanoBio's CEO and founder. "We have identified a unique approach to inducing immunity that involves nasal immune elements. Our NanoStat technology takes advantage of this pathway to produce a level of protective immunity not seen with currently available vaccines."
In naïve ferrets, NanoBio has shown that a single intranasal administration of NB-1008 containing two percent (2%) of the standard vaccine dose elicited robust immune responses, while a control arm with one full dose of a commonly-used injectable vaccine demonstrated no response. Seasonal influenza vaccines are often tested in ferrets as the animal species most predictive of human response to vaccination.
"There is an unmet need for new vaccine approaches that can address high risk individuals with less effective immunity, including the young and elderly. In addition, it would be a significant accomplishment to provide cross-protection against many strains of influenza virus that are not incorporated within the vaccine," commented Dr. Baker. "We are quite excited that extensive animal data using the NanoStat technology suggests it could achieve these goals. We look forward to the results of these trials to confirm these findings."
The Phase 1 trial is a randomized, controlled study in the United States involving 120 healthy human volunteers. The primary endpoints are safety and immunogenicity as determined by neutralizing serum antibodies.
About NanoBio’s Vaccine Platform
NanoBio's nanoemulsion-based, intranasal vaccines have elicited robust immune responses in animals vaccinated against influenza, hepatitis B, RSV, HIV, cancer, anthrax, smallpox and other diseases. The NanoStat 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 included in the vaccine; ability to adjuvant multiple antigen types without inducing inflammation; thermally stabilizing the vaccine; and removing the need for needles.