FluGen, a startup that’s developing an experimental universal influenza vaccine, is in the process of finalizing its first human clinical trial and plans to initiate three more studies next year.
Paul Radspinner, co-founder and CEO of Madison, WI-based FluGen, says his company now has data on the 96 patients who were dosed with its RedeeFlu vaccine as part of the Phase 1a trial. He says FluGen will likely submit the data for publication in a scientific journal by the end of the year, and that results of the study will be published between January and March.
Radspinner spoke with Xconomy shortly after a regulatory filing became public showing FluGen had raised $5.5 million from investors. The company has raised more than $27 million from investors and has received about $13 million in government funding since launching in 2007.
FluGen’s goals for the Phase 1a trial, which involved patients between the ages of 18 and 49, were to make sure RedeeFlu was safe and immunogenic, and to evaluate subjects’ antibody and T-cell responses to the vaccine.
“We were able to achieve all those,” Radspinner says. “That’s why we’re moving on to additional studies.”
Next year, FluGen plans to conduct a Phase 1b trial of RedeeFlu in older adults, Radspinner says. The startup also expects to initiate a study of the vaccine involving “older kids” (ages 9 to 18), which will be supported by the National Institutes of Health. According to Radspinner, flu vaccine efficacy tends to be worse among children and the elderly.
The third trial the company has planned for 2018 is a “challenge” study. It would be aimed at showing RedeeFlu can effectively fight a strain of the disease that doesn’t precisely match the strain RedeeFlu is designed to combat—a so-called “drifted” strain.
FluGen has not yet determined how many patients will participate in the challenge study, but Radspinner says he has a fairly good idea of its format. Half of the subjects will be dosed with RedeeFlu, which is administered via a nasal spray, while the other half will receive a placebo. Then, all patients will be infected with the flu.
“To our knowledge, no one has done a direct measure of efficacy with a drifted strain flu virus to date,” Radspinner says. “If we see a separation from placebo there, that will be a very good sign. None of the early-stage competitors that are out there are trying what we’re doing in terms of protecting against drifted strains.”
While next year is shaping up to be a busy one for FluGen, the 10-employee startup still has a long way to go toward its goal of commercializing RedeeFlu. The company will likely not be ready to apply for FDA clearance for RedeeFlu for several years, Radspinner says.
If the trials in 2018 and beyond go well, FluGen could decide to partner with a larger company on trials involving higher numbers of patients.
“If you look at the vaccine space, and particularly flu, the Phase 3 [trial] is usually a very large efficacy study that you have to do out in the field,” he says. “I think we would benefit from working with big pharma on something like that. [But] we certainly aren’t saying that we won’t do it ourselves.”
Last month, Sanofi (NYSE: SNY) acquired the Connecticut-based flu vaccine specialist Protein Sciences for $650 million up front, plus another $100 million in potential future milestone payments. The deal suggests that large pharma companies are willing to pay big sums for vaccines they believe have potential to be marketed globally.
Radspinner says another company that could be considered a FluGen competitor is South San Francisco, CA-based Vaxart, which is developing an oral flu vaccine.
However, neither Vaxart nor any other business that Radspinner knows of uses the same technology as RedeeFlu. The vaccine is made up of a replicating live flu virus from which a key gene has been deleted. The vaccine virus is able to live in the body just long enough to provoke a strong immune response, but thanks to the deleted gene it’s not able to cause disease or spread to other people.
“The live virus, single-replication—we’re the only one in the game there,” Radspinner says.