Moderna gains BARDA Zika vax funding; closes $474M funding round

Moderna is edging toward a total $2 billion in funding after just 5 years of life after announcing a major new funding round--which coincides with a potential $125 million BARDA grant to help fund its mRNA Zika vaccine research.

First, to its latest funding round that officially closed today with $474 million in the kitty. Specific names were not given, but the Cambridge, MA-based biotech and 2013 Fierce 15 company said that this latest equity financing included “strong support from existing institutional investors” as well as “world-class strategic pharmaceutical partners … and new institutional investors from the United States, Europe and Asia.”

Moderna did not reveal in its PR or to FierceBiotech who these investors are. It also remained schtum on its highly anticipated IPO plans. “Our focus over the coming year will be to continue advancing our pipeline into the clinic,” the company said.

“We currently have two Phase I clinical studies underway and anticipate moving additional programs into the clinic by the end of this year. We continue to evaluate the public markets and will look to go public at a time that makes sense for the company.”

“Moderna is, yet again in its short 5 years, accelerating its expansion and entering a new growth phase,” said Stéphane Bancel, CEO of the biotech.

“We are pivoting toward a new chapter in our company’s history, and we feel privileged to deploy our substantial capital resources to advance our mission to deliver on the promise of mRNA therapeutics as an entire new class of medicines.”

The cash will be used to push on with its development work and bring preclinical candidates into the lab, as well as building a new GMP manufacturing facility--all the while committing $100 million a year as a consistent investment pot for its mRNA technology platform.

Moderna currently has around $1.4 billion in cash on its balance sheet and the potential for over $230 million of extra funds from grants funnelled through a number of charitable and government bodies, including the Bill & Melinda Gates Foundation and BARDA--the U.S. government’s emergency health department.

And it is BARDA that today has also given $8 million upfront to Moderna--with the potential for a total $125 million if development goes well--for early-stage work on its Zika messenger RNA (mRNA) vaccine.

The vax is currently preclinical with the work being undertaken by Valera, Moderna’s infectious disease-focused venture, but the biotech is planning to submit an IND with the FDA by year’s end that will allow it to start human testing.

Under the funding deal, the initial $8 million will support a Phase I study, toxicology studies, vaccine formulation and manufacturing, with an extra $117 million earmarked to support Phase II and Phase III, as well as large-scale manufacturing.             

The company told FierceBiotech that based on the funding from BARDA, it shouldn’t need to add too much of its own cash to the development program: “We anticipate the award will fund the bulk of our development and manufacturing for the vaccine,” the biotech said.

It said that much of the work will be done internally, but it will call on its existing collaboration with CRO Charles River Laboratories to “support GLP toxicology studies and a collaboration with PPD to support Phase I and Phase II studies.”

“We believe our mRNA vaccine technology offers potential advantages in efficacy, speed of development, and production scalability and reliability, which may position Moderna as a leader in preparing for and responding to infectious disease threats, such as Zika, that place millions of people at risk around the world,” Bancel said of its BARDA funding.

“We feel a tremendous sense of responsibility to advance our Zika mRNA vaccine as quickly as possible, and we are thankful to BARDA for its commitment to support and help expedite our development efforts. We plan to initiate a Phase I study within the next several months.”

Moderna already has several early-stage mRNA infectious disease vaccine studies ongoing in the U.S. and Europe, having dosed around 250 healthy human volunteers to date. The company says it plans to publish its first set of clinical data from its first Phase I next year.  

BARDA is not however putting all of its eggs in one basket, having last week announced it was also paying out $19.8 million upfront and more than $300 in total to Japanese pharma Takeda for its Zika vaccine work as the transmission of the virus continues its spread across the Americas, Africa and Asia.

The deal is a similar one for both companies, although Takeda is in line for a larger funding pot, with its work also preclinical with plans for a Phase I before 2017. Sanofi ($SNY), GlaxoSmithKline ($GSK), India’s Bharat Biotech and Inovio Pharmaceuticals ($INO) are also all working on versions of their own vaccine for the virus that is believed to cause microcephaly in newborns.

These players have taken several different approaches to the vaccine, with Inovio using a DNA vaccine while Takeda is looking at an inactivated Zika virus rather than the more common attenuated-virus approach.

Moderna will use its mRNA approach, saying in a statement that it will deliver mRNA to the body’s cells, which, in turn, produce antigenic proteins as if the body was infected by a virus. “These antigenic proteins are identified and remembered by the immune system. When a person is exposed to the pathogen in the future, the body is able to recognize it as foreign and mounts an immune response, including production of antibodies that can help to destroy the pathogen.”

Moderna says that, to its knowledge, “we are the only company developing a Zika vaccine that uses mRNA to drive cellular protein expression directly.”

It has split its development programs down into a series of ventures focused on cancer, infectious diseases, rare diseases, and personalized cancer vaccines. The biotech already has a number of major backers and deals with Big Pharma, including AstraZeneca ($AZN), Alexion ($ALXN), Merck ($MRK) and Vertex ($VRTX).