Moderna has been handed an extra $472 million to run its phase 3 COVID-19 vaccine test.
The new amount is thrown on top of the $483 million the U.S. government-funded Biomedical Advanced Research and Development Authority (BARDA) has already given the biotech, bringing its total to just under $1 billion.
The extra cash comes as Moderna says it is starting its late-stage trial of mRNA-1273, its mRNA vaccine against COVID-19, today.
That money is needed as the biotech, already well funded, says it needs “to conduct a significantly larger phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification.”
The mRNA-1273 clinical plan now includes 30,000 participants in the so-called COVE test, which is being conducted in collaboration with the National Institutes of Health.
This also comes nearly a month after Moderna posted some early data from a few dozen patients showing its mRNA vaccine created an immune response. This is not, however, enough for an approval; the big phase 3 will provide the answers regulators will need to potentially approve the vaccine and will be a pivotal moment for the company and in the race for a vaccine.
“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19,” said Stéphane Bancel, Moderna’s CEO. “Encouraged by the phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”
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The randomized, 1:1 placebo-controlled trial is slated to have those 30,000 participants take the 100-µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease, with key secondaries including prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2.
Moderna says it “remains on track” to be able to deliver around 500 million doses per year, and “possibly up to 1 billion doses per year” beginning in 2021, from the company’s internal U.S. manufacturing site and collab with CDMO Lonza in addition to its new deal with fellow CDMO Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana.
There are some dark clouds over the vaccine, however: Last week, a patent court sided with Arbutus Biopharma in its dispute with Moderna, raising concerns that the intellectual property dispute could stymie COVID-19 vaccine development. The news sent shares in Moderna down 9% despite it being unclear whether the patent is relevant to its COVID-19 vaccine.
The case centers on an Arbutus patent covering lipid formulations for the delivery of nucleic acids. In filing the patent, Arbutus said the technology is based on a “surprising discovery.” Moderna disputed the novelty of the idea and took Arbutus to court on the grounds that it would have been obvious at the time of the invention.
Moderna licensed lipid nanoparticle (LNP) technology from Acuitas to enable the delivery of mRNA. The ClinicalTrials.gov listing for mRNA-1273 describes the shot as a LNP-encapsulated mRNA-based vaccine, but the mRNA specialist maintains there are no patent barriers to its progress.
Despite the dip last week, Moderna’s shares were up 7% premarket Monday morning on its BARDA boost.