Moderna Therapeutics

Moderna is focused on developing mRNA-based therapies. Their research works to overcome challenges such as delivery of the mRNA into target tissue and cells, evading the immune system and proper recognition and reading of mRNA messages by ribosomes in the cell. The company uses Amazon’s cloud platform to help speed up the process for getting drugs from research to clinical trials.

COVID-19 response

Moderna has a collaboration with Coalition for Epidemic Preparedness Innovations (CEPI) to produce a vaccine against coronavirus to fight the SARS-CoV-2 (2019-nCoV) outbreak. The coronavirus strain has more recently been renamed SARS-CoV-2 with the disease called COVID-19 (coronavirus disease). That funding will cover manufacturing costs for an mRNA vaccine candidate against the new strain of coronavirus. Preclinical tests and a phase 1 study are planned with supported from federal researchers at the National Institute of Allergy and Infectious Diseases (NIAID). In their approach for SARS-CoV-2 (2019-nCoV), Moderna is using the same technique used to produce a cancer vaccine in 40 days.

Moderna is working with Dr. Barney Graham, deputy director of the Vaccine Research Center at the NIH on SARS-CoV-2 (2019-nCoV) vaccine development. Graham’s research team used sequence information of the 2019-nCoV posted by Chinese scientists on a public database to identify a region of the genetic code to be used to generate a vaccine. The scientists focused on the spike protein, which recognizes receptors or entry points on the host cell. A template for the SARS vaccine was used with the SARS-CoV-2 (2019-nCoV) genetic code swapped in. The sequence was sent to Moderna to make synthetic mRNA for production of protein in order to generate antibodies that target the spike protein.

mRNA-1273 entered Phase I trials on March 3, 2020 and are expected to conclude on June 1, 2021.

On March 16, 2020, the mRNA vaccine called mRNA-1273 began being injected into volunteers in a clinical trial performed by Kaiser Permanente Washington Health Research Institute (KPWHRI).

Timeline

April 17, 2020

BARDA commits $483,000,000 in grant funding to Moderna Therapeutics to support its COVID-19 vaccine program.

Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (DHHS) committed $483 million to Moderna Therapeutics as the company moves forward with clinical trials of its vaccine for SARS-CoV-2, the virus which causes COVID-19.

The press release states that under terms of the agreement with BARDA, a division of the Department of Health and Human Services, the cash is expected to fund the advancement of mRNA-1273 to FDA licensure. If the Phase I portion of the study goes well, Moderna is already planning a Phase II in the second quarter of 2020 and a Phase III could begin as early as fall, the company said. 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, Moderna said in a statement.

February 2018