NanoBio Corporation is focused on developing and commercializing products based on its NanoStat technology. The platform provides the basis for therapeutic applications including intranasal vaccines (RSV, influenza), topical dermatological treatments (onychomycosis, acne), and anti-infectives (bacterial infections related to cystic fibrosis of the lung or COPD).
Clinical candidates derived from the NanoStat platform have shown activity against bacteria, viruses, fungi, and spores. A topical dermatological product derived from the platform works with nanoemulsion droplets that rapidly penetrate through pores and hair shafts to the site of the infection and physically disrupt the outer membrane of pathogenic organisms by fusing with and killing lipid-containing organisms. Unlike currently available therapies, NanoBio’s treatments are selectively toxic to microbes while non-irritating to skin and mucous membranes.1
In December 2009, NanoBio and GlaxoSmithKline plc (GSK) signed an exclusive licensing agreement in the United States. and Canada for the over-the-counter use of NanoBio’s investigational compound, NB-001, for the treatment of cold sores. NB-001 demonstrated clear efficacy and safety in randomized, double-blind, placebo-controlled Phase 2a and Phase 2b studies involving over 800 subjects with recurrent herpes labialis. In the Phase 2b study of 482 patients, NanoBio's targeted Phase 3 topical dose healed patients 1.3 days faster than placebo. In both the 2a and 2b trials, NB-001 was well-tolerated with no safety concerns or adverse events reported. NanoBio is currently preparing to study the efficacy and safety of 0.3% NB-001 in two Phase 3 trials. GSK plans to build on its Abreva brand platform with NB-001.
NanoBio’s nanoemulsion-based intra-nasal vaccines are capable of permeating the nasal mucosa, where it loads 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 producing both mucosal immunity and systemic immune response. Virtually any bacterial or viral disease that results in a human immune response is a potential candidate for the development of a nanoemulsion-based mucosal vaccine. Active development programs are underway for influenza, respiratory syncytial virus, pneumococcal infection, hepatitis B, anthrax, smallpox, cancer, and other diseases.
NanoBio’s lead vaccine candidate, NB-1008, a seasonal influenza vaccine administered via a nasal dropper, has shown promising results in a recently completed Phase 1 clinical study. The results of the Phase 1 trial, combined with research efforts aimed at identifying the most viable nanoemulsion adjuvants, will guide the future development of nanoemulsion-based vaccines. However, data suggests that NanoBio's treatment could play a key role in addressing pandemic situations by requiring far less antigen to elicit an immune response and also by potentially protecting against unanticipated strains of the virus. The company is currently in partnership discussions with several parties regarding NB-1008.
1. Hamouda T, Myc A, Donovan B, Shih A, Reuter J, Baker J, Jr. Novel surfactant nanoemulsion with a unique non-irritant topical antimicrobial activity against bacteria, enveloped viruses and fungi. Microbiol Res. 2001;156(1):1-7.