FluGen heads to PhI with universal flu vax

Nearly a year after raising $12 million to advance its universal flu vaccine candidate into human trials, Madison, WI’s FluGen is heading to the clinic. The company has kicked off a Phase I trial of RedeeFlu, it said in a statement, hoping to take on the challenge of drifted or mismatched flu strains.

In total, 96 people aged 18 to 49 will participate in the study of an intranasal vaccine containing mutations in the M2 gene of the flu virus, the biotech said in a release. The virus infects cells and expresses the “entire spectrum of influenza RNA and proteins,” FluGen said, but doesn’t cause an infection.

The placebo-controlled trial will focus primarily on safety while also looking at antibody and T-cell responses for three dose levels. FluGen has raised about $20 million since its 2007 founding, Xconomy reports.

The biotech’s clinical push is the latest development in a field that has been hailed as a “holy grail” in vaccines, with players large and small working to improve upon existing products. Recently, strain mismatches between manufactured flu vaccines and circulated strains caused low efficacy, notably 19% in the 2014-2015 season.

Companies and organizations including Sanofi ($SNY), BiondVax ($BVXV) and the National Institute for Allergy and Infectious Diseases are each working to advance universal flu candidates. For instance, the French pharma unveiled a program in November named Cobra from a genetic sequencing collaboration with the University of Georgia.

At the time, though, Sanofi Pasteur Senior Vice President of R&D John Shiver commented that while a universal flu vaccine is the "ultimate goal," it's more likely that a broader vaccine against multiple strains will be available before a vaccine that can protect against all strains.

In September, BiondVax paired with NIAID to launch a Phase II test of its candidate M-001 in the U.S.

- here's the release
- see more info from ClinicalTrials.gov
- get Xconomy's take

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