Moderna Announces Dosing of the First Monoclonal Antibody Encoded by mRNA in a Clinical Trial

Moderna, Inc., announced the dosing of the first subject in a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of mRNA-1944 via intravenous infusion in healthy adults. This is the first monoclonal antibody encoded by mRNA to be dosed in a human and the first development candidate from the Company’s systemic therapeutics modalities to start clinical testing.

“We believe this trial will give us important information about how mRNA may be used to make systemically-available complex therapeutic proteins in a consistent, dose-dependent fashion,” said Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “Dosing the first monoclonal antibody encoded by mRNA in humans is a significant milestone for our team and mRNA platform. We look forward to learning about the functionality of our mRNA-encoded antibody in neutralizing the Chikungunya virus.”

mRNA-1944 encodes a fully human IgG antibody originally isolated from B cells of a patient with a prior history of potent immunity against Chikungunya infection. It is composed of two mRNAs that encode the heavy and light chains of this anti-Chikungunya antibody within Moderna’s proprietary lipid nanoparticle (LNP) technology. Preclinical studies of mRNA-1944 showed linear dose-dependence, meaning increases in the dose of mRNA led to nearly proportionate increases in antibody production.

The research and development of mRNA-1944 was financially supported by the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense.