NanoBio initiates Phase I influenza vaccine trial

NanoBio, a biopharmaceutical company, has reported that the FDA has approved the company’s investigational new drug application for the Phase I clinical study of NB-1008, a seasonal influenza vaccine administered via a nasal dropper.

The Phase I trial is a randomized, controlled study in the US involving 120 healthy human volunteers. The primary endpoints are safety and immunogenicity as determined by neutralizing serum antibodies.

According to NanoBio, 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. The underlying technology for NB-1008 is the company’s NanoStat platform, which employs a nanoemulsion that is created through a proprietary manufacturing process.

NanoBio is in various stages of preclinical development for numerous other nanoemulsion-adjuvanted vaccines, including hepatitis B, pandemic influenza, respiratory syncytial virus, HIV, pneumococcal, cancer, anthrax and smallpox.

James Baker, Jr, CEO and founder of NanoBio, said: The initiation of this study represents a significant accomplishment for NanoBio, and enormous potential to fundamentally change vaccine development. 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.