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A needle-free vaccine platform that elicits a robust immune response against a wide array of viruses and bacteria has been awarded a U.S. patent. The University of Michigan holds the patent and NanoBio Corporation, a spin-off from the university, licenses the patent and its associated technology.
The intranasal vaccines, produced using NanoBio's nanoemulsion technology, have elicited a dramatic immune response in animals vaccinated against influenza, anthrax, hepatitis B and other diseases. In some cases, the immune response is exponentially higher than what is required to provide adequate protection against infection. Such dramatic levels of immunity would confer significantly higher levels of protection to the vaccinated population at large compared with current injectable vaccines.
Because the vaccines trigger such robust immunity, scientists anticipate they will be able to reduce vaccine antigen quantities to a fraction of what current vaccines require, while still mounting an overwhelming immune response.
This "antigen-sparing" capability would enable scientists to rapidly produce large quantities of vaccines using miniscule amounts of antigen, a critical factor when faced with a disease pandemic or biological warfare.
"We have shown that when we mix our nanoemulsion with whole virus or a recombinant protein antigen and apply it to the naso-pharynx, the resulting vaccine elicits strong mucosal and systemic immunity," said James R. Baker Jr., M.D., founder and Chairman of NanoBio Corporation. "The nanoemulsion serves as an adjuvant to boost immune response against a specific antigen."
NanoBio is in various stages of testing its extensive pipeline of mucosal vaccines for influenza, bird flu, hepatitis B, HIV, RSV, small pox, anthrax and other viral and bacterial infections. Final results from the influenza vaccine study in ferrets are expected this quarter, and human tests with the influenza and hepatitis B vaccines are being planned.
The newly awarded patent covers the methods and compositions of formulating nanoemulsion vaccines, a unique coupling of oil, water, and antimicrobial surfactant together with antigens from specific pathogens.
Studies in animals demonstrate these vaccines easily penetrate the mucous membrane, where dendritic cells rapidly engulf the antigen and present it to the immune system. This rapid awakening of the immune system via the intranasal route negates the need for inflammatory stimulants used in traditional vaccines, which can cause pain and swelling at the site of vaccination, said Dr. Baker.
"We present antigen in an optimal location where it can most directly access the immune system," added Baker. "As a result, there is no need to prime the immune system with immunostimulants in order to provoke its recognition of the antigens."
Moreover, the vaccine requires no harsh chemicals to attenuate the whole virus and render it harmless, because the nanoemulsion itself kills the antigen. Advantages of the nanoemulsion vaccines include:
-- nasal delivery, the entry point of most respiratory infections -- development of rapid mucosal immunity followed by systemic immunity -- antigen-sparing capability -- thermally stable, requires no refrigeration -- needle-free, easy to administer
The development of the nanoemulsion platform began in 1998 and is supported, in part, by a $6.3 million grant from the Bill and Melinda Gates Foundation to the Michigan Nanotechnology Institute for Medicine and Biological Sciences, which is led by Dr. Baker. The new patent for nanoemulsion vaccines (#7,314,624 B2) is licensed to NanoBio Corporation on an exclusive, worldwide basis. With this new patent, NanoBio now holds five U.S. patents and has filed numerous additional applications in various jurisdictions.
About NanoBio Corporation
NanoBio(R) Corporation is a privately held biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines derived from its patented NanoStat(TM) technology platform. The company's lead product candidates are treatments for herpes labialis (cold sores), onychomycosis (nail fungus), MRSA and mucosal vaccines for influenza and hepatitis B. The company's headquarters and laboratory facilities are located in Ann Arbor, Mich.
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