Based: Ann Arbor, MI
The Scoop: The University of Michigan's Dr. James R. Baker Jr. established a reputation long ago for groundbreaking scientific research. Now he's gaining a reputation as a biotech entrepreneur, building NanoBio around his nanoelmulsion technology and advancing new therapies for everything from cold sores and nail fungus to methicillin-resistant Staphylococcus aureus.
What makes it Fierce: For a scientist, James Baker certainly knows how to whet someone's interest in clinical data.
"Our clinical data looks better than any other topical that's ever been developed," says Baker as he discusses the mid-stage results for NanoBio's lead products. This fall the rest of the world will get a detailed look at just how far advanced the company has taken its nanoemulsion technology. In the meantime, NanoBio is making it clear that the small University of Michigan-spinout is hitting its stride.
In March, NanoBio wrapped a $30 million financing round from Perseus after hitting goals for demonstrating the safety and efficacy of its two lead therapeutics and successfully completing an animal study on its influenza vaccine. That new money came after NanoBio had raised $31 million in angel investments and grants to get started.
NanoBio is developing topical lotions -- NB-001 for herpes labialis (cold sores) and NB-002 for onychomycosis (nail fungus). Phase IIa and IIb trials for NB-001 are complete and a mid-stage trial of NB-002 is scheduled to wrap up in the first quarter of next year. An interim analysis revealed "promising results," but NanoBio is still keeping the data confidential. And safety data has confirmed that high concentrations of the lotion can be applied safely.
The University of Michigan spinout uses nano-scale particles to create therapies that can fight bacteria, viruses and fungi while the same technology platform offers a new, intranasal approach to such diseases as anthrax, influenza and hepatitis.
"We are planning to initiate a Phase III for the herpes product by the end of the year," says Baker. "The data is so robust that a single Phase III could potentially lead to an NDA. We could have an NDA submitted by late 2009."
What to look for: Partnerships make a lot of sense for NanoBio and should come relatively quickly. Baker says that Perseus is ready to supply funds as needed, and the founders are looking to grow the company as a standalone biotech.