Moderna Inc. (NASDAQ: MRNA) made a big step towards a COVID-19 vaccine early on Monday, and investors (and the stock market in general) responded very positively. Essentially, the company announced positive interim clinical data from its Phase 1 study.
Specifically, Moderna announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
So far, immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18 to 55) after two doses (day 43) and at the 250 µg level (ages 18 to 55) after one dose (day 29).
In terms of the results:
All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera.
Note that samples are not yet available for remaining participants.
Overall, mRNA-1273 was generally safe and well tolerated, with a consistent safety profile. The sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site.
Tal Zaks, M.D., Ph.D., chief medical officer at Moderna, commented:
These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg. When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.
Moderna stock traded up more than 21% early Monday to $80.83, in a 52-week range of $11.54 to $68.49. The consensus price target was last seen at $46.90.