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Moderna receives $8 million award to develop Zika mRNA vaccine
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Moderna Therapeutics received an $8 million award from the Biomedical Advanced Research and Development Authority to expedite the development of its novel Zika messenger RNA vaccine, according to a press release.
The award will support a phase 1 clinical trial, toxicology studies, vaccine formulation and manufacturing of the mRNA vaccine, with potential options for funding up to an additional $117 million to support phase 2 and 3 clinical trials, plus manufacturing.
Moderna’s mRNA approach uses in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which then are secreted or active intracellularly, according to the release.
“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,” Stéphane Bancel, MSc, MBA, CEO of Moderna, said in the release. “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.”
Bancel said Moderna plans to initiate the phase 1 clinical trial over the next several months. The goal is for Moderna to file an investigational new drug application with the FDA by the end of the year.
A grant from the Defense Advanced Research Projects Agency funded the company’s preclinical work for the Zika vaccine, with development efforts led by Valera, Moderna’s infectious disease-focused venture, according to the release.
There are two additional phase 1 mRNA infectious disease vaccine studies under Moderna in the United States and Europe, according to the release. Approximately 250 healthy volunteers have been dosed thus far, and the company expects to publish clinical data on its first phase 1 study in 2017.
“With two mRNA infectious disease vaccines already advancing through clinical studies and a growing pipeline of vaccines, all based on the same underlying mRNA vaccine technology, we’re in the fortunate position of being able to rapidly apply learnings to inform our Zika vaccine development program,” Michael Watson, MB, ChB, MRCP, president of Valera, said in the release. “It’s clear the world needs novel, innovative approaches to address both known and future infectious disease threats. We hope to be at the forefront of advancing this innovation.”
Disclosure: Bancel is employed by Moderna Therapeutics. Watson is employed by Valera.