Moderna shares were down roughly 5% in premarket trade Tuesday after it gave investors an update on its vaccine pipeline, revealing a setback for its first influenza vaccine candidate. According to the company, one of two Phase III trials being conducted on the seasonal quadrivalent vaccine mRNA-1010 "did not meet the statistical threshold necessary to declare early success."The study in question, dubbed P302, is being conducted in the Northern Hemisphere, and is evaluating mRNA-1010 against a licensed influenza vaccine. Moderna indicated that mRNA-1010 "did not accrue sufficient cases" at the trial's interim efficacy analysis, adding that an independent data and safety monitoring board (DSMB) has recommended that it keep testing the jab for more data.Previously announced interim results showed that in the Phase III P301 trial, conducted in the Southern Hemisphere, mRNA-1010 showed superiority in geometric mean titers (GMTs) for A/H3N2 and non-inferiority in GMTs for A/H1N1, but did not meet non-inferiority for both influenza B/Victoria- and B/Yamagata-lineage strains. No safety concerns have been flagged in either trial.Updated jabCommenting on the latest results, Jefferies analyst Michael Yee said "we would have liked to see the study stop early for non-inferiority." A preliminary analysis of immunogenicity from a subset of participants in P302 has also been completed, with Moderna noting that mRNA-1010 demonstrated GMT ratios "consistent with superiority" against both influenza A strains and "consistent with non-inferiority" against the two influenza B strains, relative to the licensed comparator. Moderna said it has developed an update to mRNA-1010 that is expected to have improved immunogenicity against influenza B strains, and plans to initiate a confirmatory Phase III trial this month."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 III trial," remarked CEO Stéphane Bancel.Six major vaccine launchesMeanwhile, the company also unveiled new proposed Lyme disease vaccines, mRNA-1982 and mRNA-1975, saying its "seven-valent approach" will be developed in parallel through these two candidates. Specifically, mRNA-1982 is designed to elicit antibodies for Borrelia burgdorferi, which causes almost all Lyme disease in the US, while mRNA-1975 works against antibodies for the four major Borrelia species causing disease in the US and Europe.Moderna also said it plans to file for approval of the respiratory syncytial virus (RSV) candidate mRNA-1345 this quarter. Earlier this year, Moderna reported that mRNA-1345 was about 84% effective at preventing at least two symptoms in older adults.Overall, Moderna said it expects six major vaccine product launches over the next few years, "each with significant addressable markets," and forecasts 2027 respiratory product sales between $8 billion and $15 billion. "This framework is supported by $6 billion to $8 billion of additional R&D investments over the next few years," the company said. "The annual global endemic COVID-19 booster market alone is estimated by Moderna to be approximately $15 billon," it added.Earlier this year, Moderna said it expects $5 billion in mRNA COVID vaccine sales in 2023, a steep drop from the $18 billion the shot brought in last year. The company's COVID vaccine remains its only commercially available product.
