Moderna Forms Latest Venture, Valera, to Fight Infections With mRNA

Moderna Therapeutics has been talking up plans to create a group of separate venture units based on the preclinical drug programs under its roof. That effort started last year with cancer drug developer Onkaido Therapeutics, and it continues today, as the Cambridge, MA-based company announces the formation of what’s being called Valera.

Valera is the product of Moderna’s work with the U.S. government’s Defense Advanced Research Protection Agency (DARPA). Moderna received a $24.6 million, five-year grant in 2013 to explore the use of its messenger RNA drug technology to fight infectious diseases. That work has advanced to the point that Moderna will license some of the intellectual property to Valera, which will attempt to develop vaccines and therapeutics for a variety of unspecified viral, bacterial, and parasitic infectious diseases.

It’s all based on Moderna’s work on an entirely new way of making drugs: Injecting synthetic strands of RNA into patients so that the patients’ cells can produce their own therapeutic proteins. Think of it as patients becoming their own drug factories, with Moderna providing the manufacturing instructions. If it works, that is. Moderna, and its offspring Onkaido and now Valera, have not yet tested the biotechnology in humans.

Moderna CFO Lorence Kim wouldn’t specify how many programs Valera is taking on, which diseases Valera might target first, or even how much money Moderna has invested in it. However, Kim did allow that it’s “not substantially different from Onkaido,” which was launched with a $20 million investment. That’s easy money for Moderna, as the company just raised an eye-popping $450 million—the largest financing ever for a private biotech—on Monday.

Its mRNA approach for infectious diseases could have a big advantage—if proven to work—over current methods. Vaccines, which trigger an immune response by training the body to look for certain bugs, are expensive and time consuming to create. Monoclonal antibodies have to be incubated in living cells and purified. The mRNA molecules Moderna is handing over to Valera, by comparison, can be designed and manufactured in a matter of weeks through a common chemical process.

According to Kim, Moderna found through its DARPA work that these mRNA molecules can be customized not just to express protective antibodies within patients’ bodies, but antigens as well. (Antigens are substances that spark an immune response.) Valera will be developing mRNA candidates that can do one or the other.

So far, Valera says its mRNA molecules have shown an ability in preclinical animal studies to produce either antigens that stoke the immune system or antibodies that can bind to viruses or other targets. The big question, of course, is whether Valera will be able to do the same in humans. Moderna said earlier this week that it’ll begin the first human clinical trials for its mRNA drugs in 12 to 24 months.

“Suffice to say we saw very good data that gave us confidence that the approach was viable,” says Kim.

Moderna CEO Stephane Bancel is the current acting president of Valera for now; there is a search underway for a full-time president and a chief medical officer. It also aims to hire a team of 15 scientists. Chief scientific officer Giuseppe Ciaramella, Moderna’s former VP and head of immunology and biotherapeutics, is leading that effort. Michele Keough, a former Moderna and Genzyme executive, is the company’s program manager.

Valera is part of Moderna’s plan to hive off the mRNA drugs it creates into a group of distinct companies, what it calls “venture units,” that it is incubating in house. Onkaido, formed around a group of cancer drug candidates, was the first. Bancel told Xconomy earlier this week that the company’s goal is to create five ventures over the next couple of years.

With Moderna’s massive bankroll, it has the option to keep full ownership of these venture units without putting a syndicate of backers together to move them forward.

Like Onkaido, Valera is 100 percent owned by Moderna. Kim says the company isn’t looking for outside investors for any of its ventures as of yet.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

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