VBI Progressing with Vaccines That Don’t Require Refrigeration

Expect to hear more about the vaccine developer VBI this year. The company has made some progress in addressing a major bugaboo in the vaccine field—the need to keep the vast majority of them at cool or freezing temperatures or risk spoilage.

VBI (formerly called Variation Biotechnologies), which moved its headquarters from Canada to offices closer to its venture backers in Cambridge, MA, in 2009, has been in potential partnership talks with large vaccine manufacturers and also expects to raise an additional round of venture capital this year, chief executive Jeff Baxter tells me. Recent interest in the company might stem from preclinical data on its lead vaccine for influenza, which showed that it could remain effective after enduring a year of storage in a hot environment. Today’s flu vaccines would become worthless if stored in such conditions.

Global health advocates have been calling for the development of thermostable vaccines (which are those that don’t require refrigeration) for years, and organizations such as the Seattle-based Bill & Melinda Gates Foundation have poured millions of dollars into research that could lead to such treatments. But the scientists and industry haven’t been able to bring to market thermostable vaccines for many of the world’s most devastating infections. In a December interview with the New York Times, Bill Gates said: “Back then (five years ago), I thought: ‘Wow – we’ll have a bunch of thermostable vaccines by 2010.’ But we’re not even close to that. I’d be surprised if we have even one by 2015.”

Earlier this month, Gates’s foundation, which typically provides grant funding, said it made an unprecedented equity investment of $10 million of in Research Triangle Park, NC-based Liquidia Technologies, after showing particular interest in the company’s way of manufacturing nanoparticle vaccines.

To hear VBI’s Baxter tell it, the need for thermostable vaccines exists in both the developing world, where cold storage in many areas can be difficult, and in established markets in North America and Europe. Many remote parts of Africa, for example, lack stable sources of electricity to keep refrigerators and freezers running around the clock. The problems with cold vaccine storage aren’t entirely limited to Africa, either. Vaccines spoil in the States too, sometimes leading to outbreaks.

Now VBI appears to have a shot at delivering on the promise of thermostable vaccines. Its thermostable vaccine for flu virus is expected to be ready for human trials in less than a year. At the same time, the company says that its proprietary way of formulating vaccines to keep them thermostable can be applied to both existing and developmental vaccines. And Baxter says that, unlike some of his competitors, his firm’s technology requires an extra step at the end of current processes for manufacturing vaccines and doesn’t require any changes at earlier stages of production.

“This will be one of those things where once thermostable vaccines start extending the current market, then very quickly you will see thermostable vaccines becoming the norm,” Baxter said. “Because it is such a competitive advantage to take vaccines out of the cold chain and to reduce the risk of spoilage.”

Heat alters the molecular structure of traditional vaccines and protein drugs, which are reliant on the shape of the molecules to … Next Page »

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