NIH Using Vaccines from Madison Startup FluGen in New Clinical Trial

Xconomy Wisconsin — 

Researchers are testing a flu vaccine developed by FluGen, a Madison, WI-based startup, to determine whether it can protect recipients against strains of the virus that vary from the predominant flu strain predicted by health experts each year.

Many people get a flu shot this time of year in hopes that it will help them avoid catching the virus during flu season, which typically begins in October or November. The Centers for Disease Control and Prevention (CDC) recommends that everyone six months of age or older get a seasonal flu vaccine, and the most recent flu season in the U.S. was the worst in nearly a decade.

But even those who get vaccinated sometimes fall ill. Forecasts by the CDC, World Health Organization, and other groups that predict what the predominant flu strain will be in the coming season sometimes miss the mark. Such forecasts influence how vaccine manufacturers formulate the flu shots tens of millions of Americans get each year.

The challenge of predicting which strain of the virus will predominate in a given flu season is one reason investors and research organizations have been funding companies seeking to commercialize a “universal” flu vaccine that could protect people against most strains of the disease.

FluGen has made progress in early-stage trials of its vaccine, which it calls RedeeFlu. Meanwhile, the startup is also providing flu vaccines for a current clinical trial. The National Institute of Allergy and Infectious Diseases, which is one of the National Institutes of Health (NIH), and researchers at Saint Louis University are co-managing the trial. It began in August but was not announced publicly until earlier this week.

The NIH and university researchers are conducting and managing the study, but FluGen is providing the vaccines that some participating patients will receive, says Paul Radspinner, co-founder and CEO of FluGen.

That distinguishes the trial from past and ongoing trials of RedeeFlu, which FluGen has led. Radspinner notes, however, that his startup hasn’t been acting alone. FluGen has had “funding partners” for the trials it has conducted previously, including the U.S. Department of Defense, he says.

The phase 1 trial the NIH is co-managing is aimed at assessing the safety of RedeeFlu, and whether its recipients produce an immune response, according to the agency. Fifty children ages nine to 17 are enrolled, the NIH says.

The design of RedeeFlu is aimed at giving the vaccine the ability to protect against so-called drifted—or mismatched—flu strains. That versatility could allow the vaccine to protect against strains of the virus that vary from the one the CDC and other forecasters predict will predominate in a particular season.

FluGen is not charging the NIH or its collaborators for the RedeeFlu vaccines they’ll give to some subjects, Radspinner says. For FluGen, one likely benefit of providing vaccines used in the trial will be learning how younger patients’ immune systems respond to RedeeFlu. Radspinner says that up to this point, FluGen has only studied the effects of RedeeFlu on adults.

The trial is the first FluGen has done in conjunction with the NIH, Radspinner says.

Half of the subjects in the trial will be dosed with RedeeFlu, a nasal spray manufactured with a strain of flu that was used in vaccines during the 2008 through 2010 flu seasons. The other half will receive a placebo. About three months after subjects are dosed, they will receive this flu season’s recommended vaccine.

Radspinner says the results of the study could reveal what effect, if any, receiving a different flu vaccine three months later has on subjects’ immunology. That’s something FluGen has not tested previously, he says.

Depending on the results of the NIH- and Saint Louis University-led trial, the two organizations may conduct subsequent studies of flu vaccines in younger patients. The next subjects would be five- to nine-year-olds, Radspinner says.

The live flu virus in RedeeFlu has been altered so it is missing a key protein, M2. Without it, the virus will live in the body long enough to trigger an immune response, but it won’t be strong enough to cause the disease’s severe effects or infect others, FluGen says.