Thursday March 13, 2008, 3:37 AM
James Baker, founder of NanoBio.
But University of Michigan scientists recently revealed two studies suggesting that nanoemulsion vaccines helped mice build up immunity to smallpox and HIV.
The technology, which is licensed through Ann Arbor-based firm NanoBio Corp., would use an oil-based emulsion administered through the nose rather than injecting patients using needles.
James Baker, director of the Michigan Nanotechnology Institute for Medicine and founder of NanoBio, said recent studies have indicated "that mucosal immunity may be very important in protecting individuals from AIDS."
In unrelated news, NanoBio announced that it may soon begin Phase 3 clinical trials on one of its topical lotions after getting positive clinical data and receiving a corresponding $10 million round of funding.
The firm, a spinout of the University of Michigan, has received an additional $10 million in equity funding from Perseus LLC - which has now contributed $30 million over the past 18 months to NanoBio. Perseus is a private equity investment firm with operations in New York City and Washington, D.C.
NanoBio recently said that Phase 2 clinical trial data on its topical lotion candidate NB-001 displayed positive indications that the therapy is ready for Phase 3 - the final stage before a drug reaches the market.
Company officials indicated that the firm would begin planning Phase 3 trials for NB-001 - a lotion that aims to treat cold sores using a nanotechnology-based lotion.
Baker recently spoke with Business Review reporter Nathan Bomey about the nanoemulsion studies. Excerpts:
Business Review: What was the key breakthrough in this news about the nanoemulsion vaccines?
Baker: We demonstrated that this (technology) can be used for almost any type of vaccine.
In addition, it can produce the type of immunity that's most desired for protection against viruses - that is cellular immunity that induces destruction of virally infected cells.
Have you known for quite some time that nanotechnology could eventually target HIV?
I think both of these vaccines are new in terms of how they are approached. No one has been able to produce a kill-virus smallpox vaccine before, and the uniqueness of the nanotechnology platform, I think, is very important to that.
The other thing was that recently there have been failures of a number of different AIDS vaccines. And also new evidence has come out that suggested that mucosal immunity may be very important in protecting individuals from AIDS. It makes sense.
So the fact that this vaccine produces not just cellular immunity but also mucosal immunity may make it more effective than some of the vaccines that have previously failed.
There are many different ideas about how to create a smallpox vaccine. What makes this one stand out?
The key here is that most of the applications we might use this vaccine in are really very different from what's going on with smallpox before.
There wasn't a risk with smallpox right now that justifies the risk of a live viral vaccine. So for things like a monkeypox outbreak or a suspected bioterrorism event, the risk of the vaccine may actually outweigh the risk from the event.
So having a vaccine that's safer than the current vaccine but is effective in preventing the infection if it were to occur is a really a change in the dynamic.
Talk about the market for nanotechnology-based technology. What is that market like right now?
Well the market is really wide open and there's a potential for incredible growth. We estimate that for some of the projects NanoBio is currently developing, they could be billion-dollar markets. NanoBio has at least three or four potential drugs for those markets. That gives you an idea of the potential for this technology.
What is the FDA approval process like for nanotechnology-based technology right now?
I think that it's essentially the same as any other vaccine, and we hope to be in people with at least one nanotechnology-based vaccine by the end of this year.
Has the FDA historically looked at nanotechnology suspiciously or do they see it as promising technology?
I think they see it as promising technology. Part of that's been because we've done our homework and we've made sure that anything we brought to the agency was well justified, and we've done appropriate efficacy and toxicity testing to justify their evaluation.
In the life sciences industry, we're seeing a lot of fragmentation with the big pharmas outsourcing a lot of their services. Do you think nanotechnology firms could be a target for acquisitions from the major pharmaceutical companies?
I think that's a good possibility. In some ways, it's been easier for them to evaluate traditional companies because they have milestones.
But for example, a company like NanoBio, which now has positive Phase 2 clinical trials, it (has) really breakthrough products based on nanotechnology (and) could easily be perceived as a takeover target.
Contact Nathan Bomey at (734) 302-1725 or nathanb@mbusinessreview.com.
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