Moderna announces mixed success clinical updates for mRNA pipeline
pharmafile | April 12, 2023 | News story | Research and Development |
Biotechnology company Moderna has announced clinical updates detailing the expansion and advancement of its mRNA pipeline, which includes treatments for COVID-19, influenza and respiratory syncytial virus (RSV), amongst others.
Moderna’s next-generation, refrigerator-stable COVID-19 vaccine, mRNA-1283, has been tested in multiple clinical trials and has demonstrated encouraging results. Recently, participants in a phase 3 trial to further study the effects have been dosed.
However, Moderna’s flu pipeline has had less success. The P301 southern hemisphere phase 2 trial found mRNA-1010 demonstrated superiority in geometric mean titers (GMT) for A/H3N2 and non-inferiority in GMT for A/H1N1, however it did not meet non-inferiority for both influenza B/Victoria- and B/Yamagata-lineage strains.
In mRNA-1010’s P302 northern hemisphere phase 2 trial, the independent Data and Safety Monitoring Board (DSMB) found the candidate failed to reach the “statistical threshold necessary to declare early success,” meaning not enough participants were enrolled to end the trial early.
To combat these issues, Moderna has signaled an update showing the improved immunogenicity against the influenza B strains and plans to conduct a confirmatory phase 3 trial.
For its RSV pipeline, Moderna is currently testing mRNA-1345 in ConquerRSV ‒ an ongoing phase 2/3, randomised, observer-blind, placebo-controlled, case-driven clinical trial in adults aged 60 or over. 35.541 participants over 22 countries were randomised to receive one dose of mRNA-1345 or a placebo.
Data showed a vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD). From this data, mRNA-1345 has been granted FDA Breakthrough Therapy Designation.
Stéphane Bancel, CEO of Moderna, stated: “Our mRNA platform has changed medicine and will continue to have a major impact on global health. Today we are excited to announce multiple new vaccine candidates, including for enteric viruses, such as norovirus, and targeting Lyme disease, our first bacterial vaccine. With mRNA-1010, our first investigational vaccine against seasonal flu, we are encouraged by the consistently strong immunogenicity results against influenza A, and titers consistent with non-inferiority against influenza B strains in the most recent phase 3 trial. With our mRNA platform and technology, as well as our agile manufacturing capabilities, we are confident that we can quickly develop safe and effective vaccines to address critical unmet needs.”
James Spargo
