Shares of Moderna are soaring after the company reported interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus, from a Phase 1 study led by the National Institute of Allergy and Infectious Diseases. Immunogenicity data are currently available for the 25 microgram and 100 microgram dose level after two doses and at the 250 microgram level after one dose. Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 microgram and 100 microgram dose levels, Moderna said in a statement. All participants ages 18-55 across all three dose levels seroconverted by day 15 after a single dose, the company added. At day 43, two weeks following the second dose, at the 25 microgram dose level, levels of binding antibodies were at the levels seen in convalescent sera tested in the same assay. At day 43, at the 100 microgram dose level, levels of binding antibodies “significantly exceeded” the levels seen in convalescent sera, according to Moderna. Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 microgram and 100 microgram, with the aim of selecting a dose for pivotal studies. “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 microgram,” said Tal Zaks, Chief Medical Officer at Moderna. Stephane Bancel, Chief Executive Officer at Moderna, added, “With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA.” Shares of Moderna are up 26%, or $17.14, to $83.83 in morning trading.
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