Moderna Inc. (MRNA) is actively developing mRNA-1769, an mRNA-based vaccine for mpox, targeting adult populations. The company is currently conducting a Phase 1/2 clinical trial to evaluate the vaccine’s safety, tolerability, and immunogenicity in healthy individuals. This 351-subject trial, initiated in 2023, is expected to yield data in 2025.
Recent findings published in the journal *Cell* demonstrate the promising potential of mRNA-1769. In preclinical studies, the vaccine outperformed the Bavarian Nordic A/S (BVNRY) Jynneos vaccine in preventing severe mpox disease and significantly reducing viral levels in monkeys. Jynneos, based on the modified vaccinia Ankara (MVA) virus, while effective in reducing lesions, still resulted in a significant number of animals experiencing severe disease symptoms. In contrast, none of the animals receiving mRNA-1769 reached the criteria for severe disease during the study period. Moreover, while both MVA and mRNA-1769 provided complete protection against lethal mpox infection, the mRNA-immunized animals exhibited a tenfold reduction in lesions, shorter disease duration, and substantial mitigation of viral circulation.
This research highlights the critical need for a new generation of mpox vaccines, as current options face challenges including limited supply, unfavorable side effects, and potential limitations in immunity. The development of mRNA-1769 addresses these concerns by offering a potential solution for a more effective and versatile vaccine.
In parallel, BioNTech SE (BNTX) is also developing an mRNA-based mpox vaccine, BNT166a, which is currently in a Phase 1/2 clinical trial with data anticipated in May 2025.
As of Friday’s trading, MRNA stock was down 1.39% at $72.42.