Moderna Rallies On Positive Phase 1 Coronavirus Vaccine Data, Aims For Phase 3 Trial In July

Moderna Inc MRNA shares were skyrocketing Monday after the company announced a positive interim Phase 1 readout for its coronavirus vaccine candidate mRNA-1273

Moderna's Positive Immunogenicity, Safety Data

Releasing data from the Phase 1 study conducted by the National Institute of Allergy and Infectious Diseases, the Cambridge, Massachusetts-based company said dose-dependent increases in immunogenicity were seen across three dose levels and between prime and boost within the 25-microgram and 100-microgram dose levels.

All participants ages 18-55 across all three dozen levels seroconverted by day 15 after a single dose, Moderna said. Seroconversion refers to the development of detectable antibodies in the blood directed against an infectious agent.

At day 43, two weeks after the second dose at the lowest dose of 25 microgram, levels of binding antibodies were at the levels seen in blood samples from people who have recovered from COVID-19, the company said.

At a 100-microgram dose on the same timeline, the levels of binding antIbodies exceeded the levels seen in the blood samples of a convalescing patient. 

Moderna said data regarding neutralizing antibodies were available for only the first four participants in each of the 25-microgram and 100-microgram dose level cohorts, and neutralizing antibodies were found in all eight of these participants. RNA-1273 was generally safe and well-tolerated. 

Additionally, Moderna said preclinical results from a viral challenge study in mice conducted in collaboration with the NIAID and its academic partners showed that vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2.

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What's Next For Modern's Coronavirus Vaccine Study

Following the interim Phase 1 data, Moderna said it has amended its Phase 2 study to study two dose levels — 50 micrograms and 100 micrograms — with an aim to select one dose for the pivotal studies.

The company said it expects the dose for the Phase 3 study to be between 25 and 100 micrograms. The Phase 3 study is likely to commence in July, Moderna said. 

The NIAID-sponsored Phase 1 study has been amended to include a 50-microgram dose level cohort across each of the three age groups.

"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," Chief Medical Officer Tal Zaks said in a statement. 

Last week, the FDA granted Fast Track designation for the vaccine candidate.

MRNA Price Action

In premarket trading, Moderna shares were skyrocketing 34.95% to $90. 

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