These are the Days of Moderna’s Lives: Behind the Curtain of One of the Most Mysterious Biotechs

Secretive Moderna Shakes Up R&D Model, Shows Off Early-Stage Trial Data

September 13, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Cambridge, Massachusetts – Moderna Therapeutics is ambitious, for sure, and loaded with $1.4 billion in cash. It has partnership deals with Merck & Co. , Vertex , AstraZeneca , and Alexion Pharmaceuticals , and funding from the Biomedial Advanced Research and Development Authority (BARDA) and the Defense Advanced Research Projects Agency (DARPA). It’s spending $100 million on a new manufacturing facility. So if this secretive company, which is focused on utilizing messenger RNA (mRNA) to develop a new class of drugs, is so hot, why is there so much turnover at the top of the company?

STAT ran a lengthy, gossipy exposé of the company that either portrays Moderna as an early version of Steve JobsApple with a “we’re-going-to-be-incredibly-great” attitude, or a company that’s based on difficult, questionable technology and an overly demanding top executive with delusions of grandeur.

STAT writes, “At the center of it all is Stephane Bancel, a first-time biotech CEO with an unwavering belief that Moderna’s science will work—and that employees who don’t ‘live the mission’ have no place in the company. Confident and intense, Bancel told STAT that Moderna’s science is on track and, when it is finally made public, that it will meet the brash goal he himself has set: The new drugs will change the world.”

But STAT interviewed over 20 former and current employees, almost all anonymously because of either risk of recriminations or nondisclosure agreements, and the picture it paints is of a “caustic work environment (that) has for years driven away top talent and that behind its obsession with secrecy, there are signs Moderna has run into roadblocks with its most ambitious projects.”

More than a dozen top executive left the company in the last four years, including heads of the company’s finance department, technology division, manufacturing, and science. In the last year, the heads of its cancer and rare disease programs resigned. Both had been with the company less than a year-and-a-half.

Notable among those exits was Joseph Bolen, who joined the company in 2013 to head its research-and-development activities. He is an experienced chief scientific officer who was behind Millennium Pharmaceuticals’ blockbuster drug Velcade. Bolen declined to comment when STAT asked him about his resignation.

Another problem might be the company’s technology itself. mRNA provides instructions to cells on how to manufacture specific proteins. Moderna’s goal is to engineer mRNA, insert it into cells, which will then become individual drug factories. It’s a great idea based on basic science, but the obstacles are anything but trivial. It’s very difficult to get the RNA to reach its targets. Most efforts, often utilizing nanoparticles as delivery systems, created toxicities. Novartis , Merck (MRK) and Roche all abandoned efforts due to toxicity problems.

And observers have noted that the company, which presented an ambitious list of 100 pipeline projects, has narrowed its focus to vaccines. The company has indicated the reason for that is it is the quickest route to human trials, not because other projects have faced setbacks. But vaccine development is very competitive and has a limited upside for new companies.

Katalin Kariko, an top expert in the field and vice president at one of Moderna’s competitors, BioNTech, told STAT, “I would say that mRNA is better suited for diseases where treatment for short duration is sufficiently curative, so the toxicities caused by delivery materials are less likely to occur.”

Franz-Werner Haas, the chief corporate officer of another competitor, CureVac, suggested to STAT that vaccines were low-hanging fruit. “From our point of view, it’s obvious why [Moderna] started there.”

But it can be hard to tell, since Moderna, a private company so far, hasn’t published any data. It’s not even clear how much information investors are given, although that may change as the company is making plans to launch an initial public offering (IPO).

Time will tell. The company indicates it plans to release some data soon, and the company has several ongoing clinical trials.

“We think that when the world does get to see Moderna,” Peter Kolchinsky, whose RA Capital Management invests in Moderna, said to STAT, “they’re going to see something far larger in its scope than anybody’s seen before.”

It’s hardly surprising that an investor would say that. And maybe he’s right.

A former Moderna manager told STAT, “Either we’ll be talking about it as the next Genentech , or we’ll think, ‘Well, back then, first there was Turing, then there was Valeant , and then there was Moderna.’”

MORE ON THIS TOPIC