TrialSite News profiled Moderna back in December, 2018. Recently, they reported a 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. The sponsor reports that 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—a big milestone for the company.
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 study is a randomized, placebo-controlled Phase 1 study is designed to evaluate the safety and tolerability of up to four ascending dose levels (0.1, 0.3, 0.6, 1 mg/kg cohorts with 8 subjects per cohort) of mRNA-1944 in healthy adults, administered via intravenous infusion. Other objectives are to determine pharmacodynamics in the form of serum antibody expression and whether the antibodies produced against the Chikungunya virus are sufficiently active to neutralize viral infection in vitro.