Building upon a series of successful preclinical and clinical studies, Ann Arbor-based NanoBio Corp. Tuesday announced the initiation of a second tolerability and immunogenicity study designed to test and further optimize its novel nanoemulsion-based intranasal vaccine adjuvant.

In 2009, NanoBio tested its nanoemulsion adjuvant in combination with the commercial influenza vaccine Fluzone, in a first-in-man Phase 1a study of 199 healthy adults. The intranasal nanoemulsion vaccine was well tolerated in the study and elicited both mucosal and systemic immune responses after a single administration by dropper.

In the current Phase 1b study, the nanoemulsion adjuvant will again be combined with Fluzone, and will be administered by both a sprayer device and a dropper to study the potential impact on immune response. The sprayer device will be tested using two different volumes of the vaccine. Mucosal, systemic humoral and cellular-mediated immune responses will be examined in all subjects.

“We were pleased with the safety outcome and adjuvant effect of our novel NanoStat technology observed in our previous first-in-man clinical trial,” said Ali I. Fattom, senior vice president for vaccine research and development at NanoBio. “Data generated in the current study will be important for the advancement of the nanoemulsion adjuvant for NanoBio’s flu vaccine as well as vaccines we are developing for RSV, UTI and several other diseases.”

NanoBio’s nanoemulsion-based intranasal vaccines have elicited robust immune responses in animals vaccinated against seasonal and pandemic influenza, hepatitis B, RSV, HIV, pneumococcus, 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 strains not contained in the vaccine; ability to adjuvant multiple antigen types without inducing inflammation; thermally stabilizing the vaccine; and removing the need for needles.

NanoBio 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 product candidates are treatments for herpes labialis (licensed to GSK in the U.S. and Canada), onychomycosis, acne, cystic fibrosis and a broad platform of intranasal vaccines.

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