Every year, scientists have to choose which strains of flu virus to include in the coming season’s flu shots, and when the vaccine strains don’t match the circulating strains, vaccine effectiveness can be much lower.

If FluGen has its way, though, its novel vaccine will obviate the need for all of that. It’ll protect against multiple strains of flu, even mismatched ones. And the company now has some early-phase data that shows it’s on the right track.

Several other companies, including Big Pharmas and small biotechs, are working on these so-called “universal” vaccines as well.

FluGen recently highlighted new early-phase, in-human results for its novel nasal flu vaccine designed to fight multiple seasons of influenza just as it’s looking to an NIH-sponsored trial in children and a Department of Defense-supported “challenge” study.

In the phase 1a involving 96 healthy adults, the FluGen candidate, called RedeeFlu, was safe and well-tolerated. Robust T-cell responses, as well as humoral and mucosal antibodies, were detected at significantly higher levels among those who got the vaccine versus those who received placebo shots, the company reported.

“The strong safety and immunogenicity data we see in this study are consistent with a vaccine that could provide broad and durable protection against influenza,” Robert Belshe, M.D., the study’s co-lead author, said in a statement.

RedeeFlu uses technology that came from the University of Wisconsin-Madison. It removes a gene—M2—from the flu virus so it can replicate only once in the body. Thus, the virus can’t spread to other cells to cause disease, though it can still induce an immune response just like in a natural infection. Patients naturally infected with wild-type influenza are often protected from influenza for many years, regardless of the viral strain, according to the company.

Scientists need to predict the predominant influenza viruses months ahead of the upcoming season to allow enough time for vaccine production. That opens the possibility of mismatch between the vaccine virus and the actual circulating strains, leading to lower vaccine efficacy. FluGen’s vaccine is designed to tackle this challenge.

In preclinical studies, the RedeeFlu system showed it could protect against influenza strains mismatched to the vaccine strain, a result FluGen is hoping to replicate in humans.

With the safety and immunogenicity data in hand, FluGen in May started a “challenge” study in Belgium, supported by a $14.4 million grant from the U.S. Department of Defense. In that study, healthy adults will receive the FluGen vaccine made with the A/Brisbane/10/2007 H3N2 strain of influenza, which was used in the 2008-2010 seasons. They’ll then be given intranasally the A/Belgium/4217/2015 strain, which circulated in 2015, to see whether they can fend off the genetically drifted virus.

The challenge study is expected to yield results in the first half of 2019, and the Madison, Wisconsin-based company is looking to use that data to guide its next steps, FluGen president and CEO, Paul Radspinner, said in a statement.

Meanwhile, FluGen is collaborating with the NIH’s National Institute of Allergy and Infectious Diseases on a phase 1 test in children and adolescents 9 to 17 years of age. One goal of this study is to determine whether the combination of FluGen’s vaccine and an FDA-approved seasonal vaccine leads to better protection compared with the licensed vaccine alone.

Several other companies are on their own quests toward the so-called “universal” flu shot. These include Johnson & Johnson, Sanofi, U.K. startups Vaccitech and Imutex, BiondVax and just recently Seqirus.

credit: fiercepharma