NanoBio Passes First Key Clinical Trial With Nasal Flu Vaccine, Scopes Other Opportunities

9/16/10Follow @xconomy

NanoBio has its sights set on developing a new generation of vaccines against the flu and other pathogens, and this past week the Ann Arbor, MI-based company showed the first real evidence in human beings that its approach might work.

An initial study of 199 healthy adults, presented over the weekend at the Interscience Conference on Antimicrobial Agents and Chemotherapy, showed first off that NanoBio’s nanoparticle flu vaccine candidate, NB-1008, was safe. But importantly, this formulation didn’t require any injection. And even more significantly, the formulation was able to trigger an immune response against the virus in the bloodstream and also in the mucosal membranes like those that line the nose, where people usually first breath in pathogens. This two-pronged form of immunity hasn’t been shown before in conventional flu vaccines that are injected into a muscle, or with the currently available nasal spray flu vaccine (FluMist).

“We did extensive testing, mice, ferrets, rabbits, so this study was a really a proof of concept for us in man,” says David Peralta, NanoBio’s chief operating officer.

NanoBio, founded in 2000 by Jim Baker Jr. at the University of Michigan, has pulled together more than $90 million in government and private financing over the years for its various nanotech projects. I wrote about one of those, a new preventive treatment for cold sores, back in July. But one of NanoBio’s other high priority projects has been to create a flu vaccine that can trigger strong protection against the virus for people who would rather avoid getting stuck with a needle.

What NanoBio did in this case was take a commercially available flu vaccine, and combine it with a nanoparticle designed to interact with so-called antigen presenting cells in the mucosal lining. These cells are known to process bits of a foreign invader, like flu, and present them to other cells to spark a vigorous immune defense. NanoBio made this formulation into a liquid that was delivered by a health care professional to adults in five drops, and researchers followed up 28 days later to see if it generated the desired immune response.

While the data are encouraging, the path to market is tricky with flu vaccines, so NanoBio is carefully assessing its next options. It often takes thousands of patients in clinical trials to develop a new flu vaccine, so this would take years of effort, and the support of a Big Pharma partner. Trials generally need to do more than show an immune response—they need to clear a higher bar by showing that vaccinated people are actually protected after being exposed to the flu. And much of the market for flu vaccines is already well-served by injectables, although there could be room for treating elderly people who need a more robust immune defense to flu, Peralta says.

NanoBio is discussing its options with various partners, Peralta says, and also talking more about developing vaccines for other conditions. Indeed, by showing its nanoparticle formulation was safe and able to generate an immune response, the company has generated interest from partners who are interested in applying the NanoBio technology to other vaccines, possibly for respiratory syncytial virus (RSV)—a major cause of respiratory illness—and chronic hepatitis B, Peralta says.

It will take some time to sort out the best opportunities for the technology, as well as the right partners to provide the resources it will need, but just passing that first human test was a big milestone for the company.

“It’s very important, it’s always been viewed as one of highest priority components of our platform. It takes a long time to test for safety. It’s not a quick pathway, but if we’re successful it could have very big potential,” Peralta says.

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