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Moderna to seek permission to test Zika vaccine in humans this year

Wednesday, September 07, 2016   (0 Comments)
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Moderna to seek permission to test Zika vaccine in humans this year

Cambridge-based Moderna Therapeutics is joining a select few biotechs around the world in the hunt for a vaccine for the Zika virus, thanks to an $8 million award from the federal government.

The company says it plans to file an investigational new drug application with the U.S. Food & Drug Administration by the end of 2016, which will allow it to begin Phase 1 trials on the vaccine. It’s the first time the company has disclosed that it is working on a drug to prevent the mosquito-borne infection that was declared a public health emergency by the World Health Organization earlier this year.

The company has received the $8 million from a potential $125 million award by the Biomedical Advanced Research and Development Authority, or BARDA, but says it’s already gotten funding for pre-clinical work on the vaccine from the Defense Advanced Research Projects Agency, or DARPA.

The announcement by Moderna comes a week after Takeda Pharmaceuticals, which is now consolidating its vaccine unit in Cambridge, said it, too, is developing a Zika vaccine with the help of a BARDA contract. The difference is that while Takeda’s potential vaccine will rely on inactivated viruses injected into the body to spur the production on antibodies, Moderna’s version will use genetic material, using so-called messenger RNA to create the same antibodies.

In an interview, CEO Stéphane Bancel explained that Moderna’s mRNA vaccine would get inside certain cells in the body and produce antigens, which would then be affixed to the outside of the cell. Those antigens would, in turn, spur the immune system to create antibodies to fight a potential infection, but Bancel says the method eliminates the potential for the recipient to get a low-grade infection from the vaccine itself, a danger when using whole viruses as a vaccine.

Bancel says the vaccine is intended to be used before any potential infection, since it takes “a couple weeks” for the body to build up antibodies, and is not intended to fight an infection that’s already present.

Through a subsidiary called Valera, Moderna has already said it’s in early-stage clinical trials with vaccines for two other infectious diseases. While the company hasn’t yet disclosed which ones, safety and efficacy data from those trials (in healthy volunteers) is expected early in 2017.

The company now has around $1.4 billion in cash and plans to employ about 500 people by the end of the year, making it one of the area’s largest privately-owned biotechs.

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