Moderna has secured a funding commitment of up to $483m from the US Government agency Biomedical Advanced Research and Development Authority (BARDA) to advance the development of messenger RNA (mRNA) vaccine for novel coronavirus (SARS-CoV-2).
According to the agreement, Moderna will use BARDA’s funding to advance its mRNA-1273 vaccine candidate to FDA licensure.
The mRNA-1273 is a vaccine candidate against SARS-CoV-2 encoding for a prefusion stabilised form of the Spike (S) protein, which was as selected by the company in collaboration with investigators from Vaccine Research Center (VRC).
The National Institutes of Health (NIH) is conducting the phase 1 open-label study of Moderna’s mRNA-1273 vaccine candidate.
Started in March, the phase 1 open-label study has completed enrolment of the original study, including 45 healthy adult volunteers aged between 18 years and 55 years in three dose cohorts such as 25µg, 100µg and 250µg.
Recently, the NIH has revised the phase 1 protocol to include additional six cohorts, comprising three cohorts of older adults aged between 56 years and 70 years, as well as three cohorts of elderly adults aged 71 and above. The enrolment of patients is ongoing for these cohorts.
The firm aims to start a phase 2 study of mRNA-1273 under its own investigational new drug (IND) application in the second quarter of this year, based on the safety data from the phase 1 study.
Moderna may begin phase 3 study in the fall of this year subject to data from these studies and negotiations with regulators.
BARDA will provide funding for all these late-stage clinical development programmes, in addition to scale-up of mRNA-1273 manufacture in 2020.
Moderna CEO Stéphane Bancel said: “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 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.”
In October 2019, Moderna has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational messenger RNA (mRNA) therapeutic, called mRNA-3927, to treat propionic acidemia (PA).