Vivaldi Biosciences is a rare and highly sought after property in New York City: a promising biotech startup. Why rare? Because office space is so expensive, and wet-lab space so hard to find, that most biotech companies that originate in NYC end up fleeing for some other city that has more to offer them. But Vivaldi’s far-flung startup team—which includes folks from NYC, Boston, and San Francisco—went to great lengths to keep the four-year-old company in the Big Apple.
Now Vivaldi is making strides towards reaching its first big milestone. Next quarter, the company hopes to get an application into the FDA to begin human trials of a novel flu vaccine—a product that Vivaldi executives believe could be the first truly effective vaccine in elderly people, who are most likely to suffer deadly complications from the virus. “Current vaccines leave 30 percent [of elderly people] unprotected,” says Elliott Kieff, a professor of medicine at Harvard who co-founded Vivaldi and now serves as chairman of its scientific advisory board. “What’s wonderful about this concept is it’s an entirely new strategy for attenuating the virus.”
Vivaldi’s technology originated at Mount Sinai School of Medicine in New York. Scientists Peter Palese and Adolfo García-Sastre discovered that a protein produced by a gene called Influenza NS1 prevents flu-infected cells from producing interferon. That’s a problem, because interferon really helps the human body fight off the flu, by blocking the virus from replicating.
The scientists went on to discover that deleting part of the NS1 gene essentially immobilized the flu virus, because it stimulated the cells’ interferon response, which then prevented the virus from reproducing. Studies in animals suggest that administering this mutant virus as a vaccine provides cross protection against multiple strains of the flu.
The technology could greatly streamline the annual flu-vaccine production process. Today’s vaccines are “trivalent,” meaning they raise immunity against the three influenza strains (two type A strains and one type B strain) that are expected to be dominant in the upcoming flu season. Vivaldi has generated a master truncated NS1 vaccine for all influenza A strains, and second one for all influenza B strains. The company is also developing rapid-production techniques that could make the vaccine useful in a pandemic, when huge quantities need to be produced and delivered to vaccination centers in a hurry.
The effort to turn Mount Sinai’s flu discoveries into a company started 3,000 miles away, in the office of Douglass Given (pictured above), a partner at Bay City Capital in San Francisco. Given, a scientist and physician trained in infectious diseases, had received his Ph.D. in Kieff’s lab. “I wanted to do something … Next Page »