Moderna says DSMB recommends continuation of efficacy followup for mRNA-1010

The Company’s first vaccine candidate against influenza is mRNA-1010, which is being developed in adults. mRNA-1010 is currently being evaluated in two Phase 3 trials. The first Phase 3 trial was conducted in the Southern Hemisphere to evaluate safety and non-inferior immunogenicity compared to a licensed flu vaccine. The previously announced interim results from the P301 trial indicated that mRNA-1010 demonstrated superiority in geometric mean titers for A/H3N2 and non-inferiority in GMT for A/H1N1. mRNA-1010 did not meet non-inferiority for both influenza B/Victoria- and B/Yamagata-lineage strains. mRNA-1010 demonstrated an acceptable safety and tolerability profile in the trial, and the independent Data and Safety Monitoring Board for P301 did not identify any safety concerns. The second Phase 3 trial is being conducted in the Northern Hemisphere to evaluate safety and non-inferior efficacy compared to a licensed flu vaccine. The independent DSMB has completed the first interim analysis of efficacy and informed the Company that mRNA-1010 did not meet the statistical threshold necessary to declare early success and recommended that the trial continue with efficacy follow-up towards the next analysis. The DSMB did not identify any safety concerns. Blinded follow-up for safety and efficacy is ongoing in this trial. A preliminary analysis of immunogenicity from a subset of participants in the P302 trial has also been completed. In this analysis, mRNA-1010 demonstrated geometric mean titer ratios consistent with superiority against both influenza A strains and consistent with non-inferiority against both influenza B strains relative to the licensed comparator. The P302 study did not pre-specify success criteria for immunogenicity endpoints. The Company has developed an update to mRNA-1010 that is expected to have improved immunogenicity against influenza B strains and announced plans to initiate a confirmatory Phase 3 trial this month.