At Wisconsin Inno’s latest virtual event, Paul Radspinner, the president and CEO of FluGen, revealed the startup’s progress on developing a Covid-19 vaccine as the pandemic rages on its seventh month.
The event, which took place Sept. 29, focused on FluGen’s unique approach to developing vaccines, what the biggest challenges are in making them, and what vaccine-makers need to do to ensure patients they are safe and effective.
Shortly after the pandemic began, the Madison biopharmaceutical startup began working with the University of Wisconsin-Madison and India-based Bharat Biotech to develop and test a vaccine for Covid-19.
Since its founding in 2007, FluGen has been developing vaccines to fight mutating strains of influenza around the world. And that flu vaccine candidate, known as M2SR, which is currently being tested in human clinical trials, is being used as the template to develop a Covid-19 vaccine called CoroFlu.
FluGen is constructing the CoroFlu vaccine by inserting gene sequences from SARS-CoV-2 into M2SR so that the new vaccine will induce immunity against the coronavirus, said Radspinner. FluGen was named one of Wisconsin Inno’s Crisis Innovators in August.
FluGen’s Covid vaccine is currently being tested in animals at UW-Madison’s Influenza Research Institute, and Phase I human trials are expected to start later this year at Bharat. Bharat has already commercialized 16 vaccines, including one that fights against H1H1.
“What we're trying to make sure we have is the perfect candidate … that's going to be safe and generate the immunogenicity that we need,” Radspinner said during the event. “We're watching also what's happening with the other candidates.”
Unlike some other Covid vaccine candidates, FluGen’s is given to patients intranasally, a method that targets the infection where it lives.
“If you vaccinate in the nose, then you're not going to be shedding or spreading that virus, and you're going to be able to protect yourself on top of that,” Radpsinner explained.
As FluGen gears up to test its Covid vaccine in human clinical trials, the most challenging piece will be recruiting patients for the trial who are diverse in age, ethnicity and region. Radspinner said FluGen’s initial trial will include 300 patients.
Since the pandemic began, FluGen’s staff has been working in small shifts to develop the vaccine. The startup’s scientists go into the lab for an early or late shift.
As for when society will return to normal, Radspinner said it depends on when a vaccine is ready and when enough people have received it to create herd immunity. But to get to that point, the public has to be assured the vaccine is safe.
“There's a lot of people who are what we call vaccine hesitant,” Radspinner said. “Instead of demonizing those people, the important thing is to understand what what's behind the concern. It's a huge challenge, and I know we're up to it.”
