Moderna stock dips after flu shot fails to meet early success threshold, trial continues
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Moderna (NASDAQ:MRNA) said its seasonal influenza (flu) vaccine mRNA-1010 did not accrue sufficient cases at an interim efficacy analysis to declare early success in a phase 3 trial conducted in the Northern Hemisphere.
Moderna noted that it has developed an update to mRNA-1010 which is expected to have improved immunogenicity against influenza B strains and announced plans to start a confirmatory phase 3 trial this month.
Flu vaccine program:
Earlier in February, the company had reported mix results for the flu shot from a phase 3 trial called P301, which was carried out in the Southern Hemisphere. The vaccine had not shown non-inferiority for either goals of seroconversion rates and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strains.
On Tuesday, Moderna provided updates on its clinical programs, including the second Phase 3 trial, dubbed P302, of mRNA-1010 conducted in the Northern Hemisphere to evaluate safety and non-inferior efficacy compared to a licensed flu vaccine.
The company said that an independent Data and Safety Monitoring Board (DSMB) completed its first interim analysis of efficacy and informed that mRNA-1010 did not meet the statistical threshold required to declare early success and recommended that the study continue with efficacy follow-up towards the next analysis.
Moderna said that the P302 study did not pre-specify success criteria for immunogenicity goal.
A preliminary analysis of immunogenicity from a subset of participants in the trial showed, that mRNA-1010 demonstrated geometric mean titer ratios consistent with superiority against both influenza A strains (A/H1N1, A/H3N2) and consistent with non-inferiority against both influenza B strains (B/Victoria, B/Yamagata) relative to the licensed comparator.
"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," said Moderna CEO StÃ©phane Bancel.
The company said that it has five influenza vaccine candidates in clinical development.
Respiratory Syncytial Virus (RSV) program:
Moderna expects to file for approval of its investigational RSV vaccine mRNA-1345 this quarter.
The vaccine is in an ongoing phase 2/3 trial, dubbed ConquerRSV, in adults aged 60 years and older.
After review by an DSMB, the main efficacy goals were met, including vaccine efficacy (VE) of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms, the company added.
COVID-19 vaccine portfolio:
Moderna said its next-generation, refrigerator-stable COVID-19 vaccine mRNA-1283, has shown encouraging results in multiple clinical trials and recently began dosing people in a phase 3 trial.
Commercial Updates:
Moderna said it expects six major vaccine product launches in the next few years. The annual global endemic COVID-19 booster market alone is estimated by Moderna to be about $15B.
The company estimates respiratory product sales in 2027 to be between $8B and $15B with corresponding Respiratory operating profit in the range of $4B to $9B. This framework is supported by $6B to $8B of additional research and development investments over the next few years, according to Moderna.
MRNA -4.78% to $152.50 premarket April 11