Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services, to accelerate development of the company’s mRNA vaccine candidate, mRNA-1273, against the novel coronavirus.

Under the agreement, BARDA will fund the advancement of mRNA-1273 to FDA licensure. A Phase I study of mRNA-1273 is being conducted by the US National Institutes of Health (NIH). The Phase I open-label 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. The NIH recently amended the Phase I protocol to include an additional six cohorts: three cohorts of older adults (ages 56 -70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing.

If supported by data from the Phase I study, Moderna says it intends to begin a Phase II study of mRNA-1273 under its own Investigational new drug application in the second quarter of 2020. Subject to data from these studies and discussions with regulators, the company says a Phase III study could begin as soon as the fall of 2020. BARDA funding will support these late-stage clinical development programs as well as the scale-up of mRNA-1273 manufacture in 2020 to enable potential pandemic response.

To support the scale-up, Moderna says it plans to hire up to 150 new team members in the US this year (2020). This includes additional manufacturing staff to expand manufacturing capacity from two shifts per day, five days per week to three shifts per day, seven days per week, engineers to manage process scale-up, and clinical and regulatory staff to support clinical development.

mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the US National Institutes of Health (NIH). The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, a global alliance financing and coordinating the development of vaccines against emerging diseases, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 2020. The first participant in the NIH-led Phase I study of mRNA-1273 was dosed on March 16, 2020.

Source: Moderna