The U.S. Biomedical Advanced Research and Development Authority (BARDA) commitment of up to $483 million to accelerate Moderna Inc.’s mRNA vaccine candidate, mRNA-1273, in efforts to fight coronavirus (SARS-CoV-2) would enable the company to supply millions of doses per month in 2020 and tens of millions per month in 2021 if the vaccine candidate is successful in the clinic.
The commitment calls for BARDA, part of the Department of Health and Human Services (HHS), to fund mRNA-1273’s advancement all the way to FDA licensure, including the vaccine’s scale-up costs.
Stéphane Bancel, Moderna’s CEO, told investors in Friday’s conference call that the funding “is very critical for our ability to supply as many doses as we can, as fast as we can in parallel to the clinical plan without waiting for the derisking for the typical phase I, phase II, phase III. BARDA is awarding some considerable capital, so that we can work on the manufacturing process scale-up, so that we can increase our scale in production as fast as we can, so that we can maximize the output.”
The first patient in the NIH-led phase I open-label trial was dosed with mRNA-1273 on March 16 in Seattle. If the safety data are favorable, Moderna plans a phase II study in the second quarter of 2020. Looking further ahead, the company said a phase III could begin by this fall.
None of the grant money is earmarked for marketing, Bancel said, adding that should the trial fail at any stage, the costs earmarked for further efforts will not be paid.
The phase I is fully enrolled with 45 healthy adults from ages 18 to 55. Moderna is expanding the phase I to six additional cohorts, three involving patients ages 51 to 70 and three more targeting those ages 71 and older. Enrollment for the new cohorts is ongoing.
J.P Morgan’s Cory Kasimov likes Moderna’s chances with the vaccine, writing that “we see a high likelihood that the first look at the COVID-19 data will be favorable given that MRNA has gone 8-for-8 in phase I vaccine readouts.”
The government commitment also accelerated the Cambridge, Mass.-based Moderna’s stock, as shares (NASDAQ:MRNA) traded 15.39% higher on Friday to close at $46.85 each.
The grant is designed to allow Moderna to staff up its U.S. headcount by 150 by year-end, mostly in clinical development, clinical operation, regulatory, research for assay development, process development and process scale-up, Bancel said.
“The analogy we have within Moderna is that we're going to grow in six months what would have taken us four years to grow,” Bancel said.
On March 24, Bancel predicted that, whether through the actual infection or through a vaccine, “in 18 to 24 months, I believe most of the world will be seropositive.”
Ginkgo Bioworks Inc., of Boston, will collaborate with Moderna to generate raw materials used in mRNA vaccine manufacturing, including mRNA-1273. In the past five years, Ginkgo said it invested $400 million in automated bioengineering and brings microbial discovery, production and fermentation, along with academic researchers, to the table for the deal.
This isn’t the first time Moderna has received BARDA money. In September 2016, Moderna landed its first grant from the authority for $8 million, and potentially up to $125 million, to advance a mRNA-based Zika vaccine. On April 14, the company reported the first interim analysis of the phase I Zika vaccine candidate (mRNA-1893) study, showing that 10-µg and 30-µg dose levels seroconverted 94% and 100% of seronegative participants, respectively, and effectively boosted seropositive participants. Both dose levels were generally well-tolerated, the analysis showed. The candidate was granted fast track designation by the FDA in August 2019.
Other companies conducting preclinical studies of mRNA vaccines for COVID-19 include Arcturus Therapeutics Inc., Biontech Inc., Tubingen, Germany-based Curevac AG and Pfizer Inc. Arcturus, of San Diego, said it plans to initiate a clinical trial for its COVID-19 vaccine, also known as LUNAR-COV19, a very low dose, potential single-shot, self-replicating mRNA vaccine that is devoid of any viral material or co-adjuvants. New York-based Pfizer and Biontech, of Mainz, Germany, agreed to develop a COVID-19 vaccine and scale manufacturing capacity. Biontech will contribute multiple mRNA vaccine candidates as part of its BNT-162 COVID-19 vaccine program.
A new NIH pandemic task force
Also late this week, the NIH and the Foundation for the NIH said they are creating a task force composed of more than a dozen biopharmaceutical companies, the HHS’ Office of the Assistant Secretary for Preparedness and Response, the CDC, the FDA and the EMA to develop an international strategy for a coordinated research response to the COVID-19 pandemic. The partnership, Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), is designed to prioritize vaccine and drug candidates, streamline clinical trials, coordinate regulatory processes and/or leverage assets among all partners to rapidly respond to COVID-19 and future pandemics.