Ann Arbor-based NanoBio Corp. has published data from its ferret influenza vaccine study of its NB-1008 product in the July 2011 issue of Clinical Vaccine Immunology by the American Society of Microbiology.

NanoBio said the study demonstrates robust influenza immunity and provided the necessary validation to move immediately into human studies.

A Phase 1a study of NB-1008 was subsequently completed in 2010, showing NB-1008 was well-tolerated while inducing both mucosal and systemic immunity following intranasal vaccination.

The publication, entitled “Intranasal Immunization of Ferrets with Commercial Trivalent Influenza Vaccines Formulated in a Nanoemulsion-Based Adjuvant,” describes the protocol and results of NanoBio’s large study in ferrets, which represents the animal model most predictive of human response. NB-1008 created robust systemic immunity against influenza, without evidence of toxicity or tolerability concerns. In addition, NB-1008 elicited cross-protection to all five H3N2 influenza strains tested, none of which were included as part of the vaccine.

“In this ferret study, we used doses of antigen at 1/50th of the standard commercial dose, and then combined the antigen with our nanoemulsion adjuvant prior to vaccination,” said Ali I. Fattom, Ph.D., Senior Vice President of Vaccine Research and Development, NanoBio. “Despite the low antigen dose, the ferrets vaccinated responded with robust systemic titers against influenza. These data reflect the significant antigen-sparing properties of our nanoemulsion adjuvant platform. In addition, the cross-protection observed indicates our adjuvant can enhance cross-reactive antibodies, which could play an important role in developing a future universal vaccine for influenza.”

James R. Baker Jr., M.D., NanoBio’s founder and CEO, added: “We have selected influenza as our lead vaccine candidate as a model or proof of concept for our nanoemulsion adjuvant platform. The research described in this publication represents a critical step for NanoBio, and provided the impetus for proceeding directly to Phase 1 studies. As we stand today, we are currently conducting a Phase 1b study in influenza to optimize our results in humans. In parallel, we are aggressively pursuing development programs for nanoemulsion-adjuvanted vaccines for RSV and UTI, based on the promise we have seen with our influenza vaccine.”

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 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 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. The company’s lead product candidates are treatments for herpes labialis (licensed to GSK in the U.S. and Canada), onychomycosis (nail fungus), acne, cystic fibrosis and a broad platform of intranasal vaccines.

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