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."