Moderna's billion-dollar R&D shop partners up to finally enter the clinic

Moderna CEO Stéphane Bancel

Moderna Therapeutics, a high-profile private biotech with scores of preclinical projects, is finally moving toward human trials, recruiting one of the world's largest CROs to help get its much-hyped pipeline moving.

The Cambridge, MA, company signed a risk-sharing deal with contract researcher PPD, bringing the CRO aboard to help plan clinical trials, clear regulatory hurdles and test out its therapies over the coming years.

Moderna burst onto the biotech scene in 2012, coming out of stealth with the radical promise of transforming patients' bodies into drug factories. The biotech's core technology uses messenger RNA (mRNA) to spur the production of human proteins within patient cells, creating what the company describes as an in vivo factory for targeted therapies. The promise of such an idea has helped Moderna raise $1 billion in venture cash and collaboration dollars since its foundation, and the company says it has amassed a pipeline of more than 50 preclinical mRNA treatments scattered across four area-specific subsidiaries.

But not one of those candidates has been tested in a clinical trial. Moderna CEO Stéphane Bancel has said the company plans to change that this year, and now PPD is on hand to help out.

Moderna didn't disclose any financial details related to its CRO deal but said its relationship with PPD will go beyond the standard client-vendor model and instead be "built around a unique risk-sharing model that incentivizes both organizations to achieve shared milestones." Moderna also isn't providing a specific timeline for clinical development, and the company hasn't said which treatments, disease states or even therapeutic modalities it intends to progress first.

"We are building a high-quality, scalable clinical development capability to match the accelerated output of our mRNA research, which will require the ability to test many mRNA therapeutics in clinical trials in parallel each year," Bancel said in a statement.

In October, Moderna's chief scientific officer quietly left the company before resurfacing at PureTech Health, leading the company to task President Stephen Hoge with overseeing its research operation while Chief Medical Officer Tal Zaks, formerly of Sanofi ($SNY), handles therapeutic development.

- read the statement