NanoBio Corporation announced on December 2nd positive results from studies in mice in which immune responses were evaluated following administration of 5µg doses of recombinant H5N1 pandemic flu antigen combined with the company’s novel nanoemulsion vaccine. These studies are unique because the adjuvant was administered for the first time by subcutaneous (SC) and intramuscular (IM) injections. The mice that received either SC or IM H5 antigen combined with nanoemulsion had maximal immune responses at least a 1000 fold higher than control animals that received the same antigen IM without the nanoemulsion adjuvant. SC and IM administered NanoBio adjuvanted vaccines should share many of the advantages, including antigen-sparing properties, previously demonstrated in studies where the adjuvant was administered intranasally.
“It is encouraging that these strong immune responses were achieved without evidence of significant irritation or inflammation, which could differentiate these IM vaccines from currently approved IM adjuvants,” commented James R. Baker, Jr., M.D., founder and CEO of NanoBio Corporation. “These new data further demonstrate the broad safety and potential universal applicability of NanoBio’s vaccine adjuvant platform for immunization in a method most appropriate for the particular disease.”
The underlying technology is NanoBio’s NanoStat™ platform, which employs a nanoemulsion that is created through a proprietary manufacturing process. The nanoemulsion has previously proven to be uniquely capable of permeating the nasal mucosa, where it can load vaccine antigen into immune-presenting cells. Earlier this year, the U.S. Food and Drug Administration (FDA) 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. The Phase 1 study is ongoing.
NanoBio’s nanoemulsion-based, intranasal vaccines have elicited robust immune responses in animals vaccinated against seasonal and pandemic influenza, hepatitis B, RSV, HIV, pneumococcal, anthrax, smallpox and other diseases. The company’s NanoStat™ adjuvant 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 non-vaccinated strains; ability to adjuvant multiple antigen types without inducing inflammation; thermally stabilizing the vaccine; and removing the need for needles.
NanoBio® Corporation is a privately held biopharmaceutical company focused on developing and commercializing dermatological products, anti-infective treatments and intranasal vaccines derived from its patented NanoStat™ technology platform. The company’s lead dermatology and anti-infective product candidates include treatments for herpes labialis (cold sores), onychomycosis (nail fungus), tinea capitis, acne, molluscum contagiosum, and cystic fibrosis. The company’s headquarters and laboratory facilities are located in Ann Arbor, Michigan. NanoBio is a spin-off from the University of Michigan and holds the exclusive global license to the nanoemulsion platform technology.