Spencer Fordin
How does a tiny eight-person company take on one of the world’s toughest tasks?
By being in the right place at the right time.
Oragenics, a Tampa-based medical research business with roots in Gainesville, found itself at a crossroads earlier this year right before the COVID-19 pandemic struck America.
The company’s previous project had been working on modifying genes related to bacteria in the hopes of stopping oral mucositis in patients undergoing chemotherapy.
Test results did not show the desired results, though, and Oragenics CEO Alan Joslyn said his company could not justify spending another $30 million on clinical trials.
“We had invested four years in conducting that clinical trial and the separation between placebo and active just wasn’t enough to be able to compete in the marketplace,” he said. “We had just failed a large clinical trial. We still had cash on our balance sheet. We had infrastructure.”
And they had an opportunity.
Oragenics, founded in 1996 by University of Florida professor Dr. Jeffrey Hillman and Dr. Robert Zahradnik, was looking for a new direction when it became aware of a firm in a fortuitous position.
Their attorney informed them of another client of his, Noachis Terra Inc., which had a license from the National Institutes of Health to utilize a spike protein in the creation of a COVID-19 vaccine. Just like that, Oragenics went from a bacterial research company to an infectious disease company.
“We only have eight people working in the company and it’s a virtual company. We can make decisions in minutes with a phone call,” said Joslyn. “That flexibility and fungibility is very important in this day and age in that we don’t have to go to multiple committees and go through the process of having money put in or taken out of a budget. There’s only one budget.
“People look at us like, ‘You’re only eight people. How are you going to compete with Johnson and Johnson?’ But there are certain advantages to being small and nimble and having a good plan.”
The irony of the merger with Noachis Terra, said Joslyn, is the proximity. Nocahis Terra was also based out of Gainesville, and the merger quickly came together over a matter of weeks.
Oragenics acquired Noachis Terra for $1.9 million and 9.2 million shares of Oragenics’ stock, and then it began embarking on the process of working on the vaccine.
“Remember, this is March and April when COVID-19 was just flaming everywhere. There was a certain urgency in getting involved as quickly as you could and not falling behind,” said Joslyn of the timing. “You have these two UF companies having never met before, one of them being private and having a license from the NIH, the other being public and having cash and a listing.
“It only took us two weeks to complete the transaction once we both knew. It’s very rare to end up in a situation where both companies are so very clear and so diametrically opposite.”
So how does the vaccine work? Oragenics and Noachis Terra have a license to work on a spike protein developed by the NIH over decades of research into other types of coronavirus.
And while some companies want to just use the protein as a direct catalyst to your immune system, Oragenics is taking a detour that may yield a significant dividend down the road.
“Moderna is working with a very similar spike protein that we are,” said Joslyn, who holds a Ph.D. from the State University of New York at Buffalo. “The difference is they’re trying to use RNA being directly inserted into cells in your body to make the antigen whereas I an putting my gene into these Chinese hamster ovary cells and making protein that is the actual spike protein and that’s my antigen. This speaks to different approaches using the same information — the gene — to make the unique vaccine itself.
“The marketplace may use the Moderna Messenger RNA vaccine in some countries and some subsets of people, and they may use that same protein, that same gene that came from Oragenics in a different part of the world or different population of patients.”
Oragenics is applying for a BARDA grant to defray some of the costs in mass production of the vaccine, and the company has spent a lot of time lobbying Florida politicians for support.
Joslyn said there are so many questions that scientists don’t know. Will antibodies developed in response to COVID-19 dissipate over time? Can a patient catch the virus more than once? If so, said Joslyn, that would be evidence that herd immunity may not be a panacea.
The hard part about producing a vaccine so quickly is that there is no opportunity to answer those questions. It could take years in a normal setting to develop a vaccine, and companies would use that time to conduct clinical trials against all demographics and against the use of placebos.
That’s another reason why Joslyn said the market is seeking safety in a number of approaches. Time is of the essence, so it makes more sense not to put all your eggs in one basket.
“Creating antibodies and measuring them may not be enough to be able to tell long-term how good certain types of vaccines are,” he said. “Some are RNA vaccines and some companies are working with attenuated viruses. And then people like us who are using recombinant proteins. Each one of these types of vaccines may produce a very different immunological response in a population.
President Donald Trump has announced Operation Warp Speed in the hope of producing 300 million doses of a safe, effective COVID-19 vaccine by January of 2021.
It’s a gigantic task. And not only because it will require lots of doses to heal the world, said Joslyn, but because everybody in the world may need more than one dose.
“You have to make an awful lot of vaccine to cover something like this,” he said. “You have to have some blind faith with some of this. But it’s worth taking the chance.
“We’re trying to navigate the process of increasing awareness in what we’re doing using as much support at the state and federal level to at least try and keep up the Mercks and the Pfizers and the Johnson & Johnson’s of the world to have our voice heard. We’re working on this too.”
