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September 7, 2016

Moderna Wins Up to $125M from BARDA toward Zika mRNA Vaccine

  • Moderna Therapeutics said today it will receive up to $125 million from the Biomedical Advanced Research and Development Authority (BARDA) toward developing a Zika virus vaccine.

    The award is the second potentially nine-figure BARDA contract awarded in less than a week toward Zika vaccine development. On Thursday, Takeda Pharmaceutical announced an award of up to $312 million  toward its own inactivated, adjuvanted, whole Zika virus vaccine.

    Moderna said its BARDA award will accelerate development of a Zika messenger RNA (mRNA) vaccine. The award will consist of an initial $8 million to support a Phase I clinical study, toxicology studies, vaccine formulation, and manufacturing—as well as options for additional funding of up to $117 million to support Phase II and Phase III studies, as well as large-scale manufacturing.

    “We plan to initiate a Phase I study within the next several months,” Moderna CEO Stéphane Bancel said in a statement. “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.”

    Moderna said it has already carried out preclinical work for the Zika mRNA vaccine, funded through a grant from the Defense Advanced Research Projects Agency (DARPA).

    Efforts to develop Moderna’s Zika mRNA vaccine are being led by the company’s infectious disease-focused venture, Valera.

    Moderna’s vaccines are designed to deliver mRNA to the body’s cells, which respond by producing antigenic proteins that are identified and remembered by the immune system. When a person is exposed to the pathogen in the future, Moderna reasons, his or her body will mount an immune response, including production of antibodies that can help to destroy the pathogen.

    To date, Moderna said, it has launched two Phase I studies assessing its mRNA vaccine in undisclosed infectious diseases in the U.S. and Europe, with approximately 250 volunteers dosed to date. The company expects to publish clinical data on its first Phase I study next year.

    Separately today, Moderna said it received $474 million in equity financing from undisclosed “existing institutional investors and world-class strategic pharmaceutical partners as well as participation of new institutional investors from the United States, Europe and Asia.”

    Combined with previous funding, Moderna said it now has $1.4 billion in cash, plus the potential for $230 million more—consisting of the BARDA award, another up-to-$100 million from the Bill & Melinda Gates Foundation disclosed in January, and funding from DARPA.

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