To any other private biotech, sinking $110 million into a custom-built manufacturing facility while its most advanced programs are in Phase II would be unthinkable. But not for Moderna, a prominent Cambridge, MA-based startup that’s deep into so-called unicorn territory with a reported valuation of $5 billion.
The boundless optimism doesn’t end there; the lease for a 200,000-square-foot facility lasts 15 years, with options after that to renew. The site is slated to open in early 2018, with the work starting next month.
The new clinical manufacturing facility will be staffed with 220 employees and be based just outside of Boston in Norwood, MA. Moderna currently employs 460 people at three locations and plans to add 100 new employees at the Norwood facility.
This massive manufacturing investment is just like change in the couch cushions for the amply supported startup, which has brought in about $2 billion since its inception 5 years ago.
Moderna hopes to create massive manufacturing bandwidth to support its outsized clinical ambitions. Its fundamental premise is to create messenger RNA therapeutics to produce human proteins and antibodies and other protein constructs within a patient’s own cells.
“We are designing the Norwood site to accommodate a broad range of GMP manufacturing needs that reflect the diversity of our pipeline--from small-scale, rapid cycle-time manufacturing of personalized cancer vaccines to larger scale Phase II clinical study supply across a number of therapeutic areas,” said Moderna Manufacturing and Operations SVP Steve Harbin in a statement.
The potential, if it works, is enormous since it could theoretically enable patient cells to create, use and secrete the equivalent of almost any major existing biologic drug--in addition to enabling it to hit targets that are currently thought to be undruggable. As if that weren’t enough, it’s also working on personalized cancer vaccines.
The biotech is plowing ahead in order to support its ambitious clinical plans. It has two ongoing Phase II trials and is working on IND-enabling studies for 8 additional programs. Moderna said in January that it plans to have 6 clinical trials ongoing by year end
So, it’s gearing up to support all this parallel clinical development activity. The company is already working with CROs Charles River Laboratories and Pharmaceutical Product Development (PPD) to support its clinical studies.
Its primary development focus is on four areas: oncology, infectious diseases, rare diseases and personalized cancer vaccines. These are each housed within separate “venture companies” within Moderna.
The startup was founded by Flagship VentureLabs and has partnerships with AstraZeneca ($AZN), Alexion Pharmaceuticals ($ALXN), Merck ($MRK) and Vertex ($VRTX). Its investors include several major biotech crossover investors such as Invus, RA Capital Management, Viking Global Investors and Wellington Management.