Moderna is engaged in developing messenger RNA (mRNA) therapeutics and vaccines for advanced transformative medicines for patients
US-based clinical-stage biotechnology firm Moderna has unveiled positive interim clinical data from the Phase 1 study of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), which causes Covid-19.
The Phase 1 clinical trial is led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The company is engaged in developing messenger RNA (mRNA) therapeutics and vaccines for advanced transformative medicines for patients.
Moderna chief medical officer Tal Zaks said: “These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg.
“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent Covid-19 disease and advance our ability to select a dose for pivotal trials.”
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for Spike (S) protein
The company has released immunogenicity data for the 25µg and 100µg dose level in patients aged between 18 and 55 years, after two doses and at the 250µg level in patients aged 18 to 55 years after one dose.
The vaccine has shown dose-dependent increases in immunogenicity across the three dose levels, and between prime and boost within the 25µg and 100µg dose levels, said the company.
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilised form of the Spike (S) protein. Moderna has partnered with Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH, to develop the mRNA vaccine.
The US Food and Drug Administration (FDA) has recently reviewed Moderna’s investigational new drug (IND) application for its mRNA-1273, which allows the company to conduct a Phase 2 study
Also, the US regulatory agency has granted fast track designation for mRNA-1273 Moderna is finalizing the protocol for a Phase 3 study, expected to begin in July 2020.
The Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services (HHS), has provided funding for the Phase 2 and Phase 3 studies of mRNA-1273.
Furthermore, the funding is also expected to support the clinical studies, along with scale-up of mRNA-1273, manufactured both at the Moderna’s and Lonza’s facilities.
Moderna chief executive officer Stéphane Bancel said: “With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA.
“We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”