Shares of Moderna Inc. (MRNA) are up more than 21 percent in extended trading on Thursday after the Biomedical Advanced Research and Development Authority (BARDA) committed up to $483 million to accelerate the development of the Company’s mRNA vaccine candidate mRNA-1273 against the novel coronavirus.
The experimental vaccine mRNA-1273 is currently under a phase I study, being conducted by the National Institutes of Health (NIH).
The phase I study, which began on March 16, 2020, has completed enrollment of the original study – 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts (25 µg, 100 µg and 250 µg). The NIH recently amended the phase I protocol to include an additional six cohorts: three cohorts of older adults (ages 51-70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing.
If all goes well as planned, a phase II study of mRNA-1273 is expected to begin in the second quarter of 2020. Subject to data from these studies and discussions with regulators, a phase III study could begin as soon as fall, 2020, according to the Company.
The BARDA funding will aid in the advancement of mRNA-1273 to FDA licensure as well as the scale-up of mRNA-1273 manufacture in 2020 to enable potential pandemic response.
With the vaccine development gaining steam, Moderna plans to hire up to 150 new team members in the U.S. this year, including skilled manufacturing staff, engineers, and clinical and regulatory staff.
Commenting on the BARDA award, Stéphane Bancel, Moderna’s Chief Executive Officer, said, “We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2. Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for the pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.”
A couple of companies like Arcturus, CureVac, and BioNTech are also trialing mRNA vaccines against COVID-19, and they are all under pre-clinical development.
MRNA closed Thursday’s trading at $40.60, up 8.99%. In after-hours, the stock gained 21.87% to $49.48.
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