A vaccine that would prevent strep throat in North America inched a bit closer to the market this month.
Vaxent, the Memphis company that owns the therapy, has partnered with Saskatchewan’s Pan-Provincial Vaccine Enterprise Inc. (PREVENT).
The nonprofit, quasi-governmental group specializes in getting drugs through clinical trials, one step of many in the process of getting drugs out of labs and onto doctors’ shelves.
“They have the resources and the mission to carry vaccines forward that wouldn’t otherwise have any other mechanism of support,” said Dr. Jim Dale, Vaxent’s chief scientific officer and vaccine co-creator. “We had the technology, the know-how and the background to complement that, and now we’re a team.”
The vaccine would cover Group A streptococcus, which includes strep throat but also includes other diseases, such as streptococcal toxic shock syndrome, necrotizing fasciitis (flesh-eating bacterial infection), acute rheumatic fever and rheumatic heart disease.
The vaccine has been developed over the past 25 years at the University of Tennessee Health Science Center by Dale and Gene Stollerman, a university professor. But Dale said work on the therapy began more than 40 years ago, and most of that work has been funded by grants from the Veterans Administration and the National Institutes of Health.
The formula was licensed to a small Seattle company for a time before the company, ID Biomedical Corp., was sold to the behemoth GlaxoSmithKline. GSK, however, was not interested in the strep throat vaccine, Dale said, and he was able to negotiate its license back and formed Vaxent in 2008.
Innova, the Memphis-based group that invests in start-ups, was an early Vaxent backer and remains its only investor, Dale said.
“If we can demonstrate the effectiveness of this vaccine, it can change the lives of children around the world and should be a very good business return,” said Ken Woody, Innova president.
However, it will still be three years until the vaccine is finished with its first human clinical trial. Dale said neither Vaxent nor PREVENT has the resources and the millions of dollars it will take to guide the vaccine through all of the FDA-mandated regulatory stages and into the marketplace.
He said he hopes a big pharmaceutical company will watch and appreciate the work on the drug and either purchase it from them or buy and share a license agreement for it.
Dale said patience is a key in the drug development business and you have to be prepared for “backslides,” when your company is moved back from its goal.
“Anything in medicine or biology is going to have unknowns,” Dale said. “Once you mix in the business, money, regulatory and clinical development sides, it accentuates the unknowns.”
Woody claimed the business is not for the faint of heart, but said Innova is “pretty much where it expected to be” with Vaxent.