Moderna reported positive data from a three-month interim analysis of safety and immunogenicity data from the Phase 1 study that is evaluating its investigational cytomegalovirus — or CMV — vaccine codenamed mRNA-1647.
The therapeutic is part of Modern's prophylactic vaccine portfolio.
The company said mRNA-1647 is a vaccine combining six mRNAs in a single vial that encodes for two antigens on the surface of CMV, and it is designed to produce an immune response against the pentamer and gB for the prevention of CMV infection.
A safety analysis showed that the vaccine was well-tolerated, producing no vaccine-related serious adverse events, according to Moderna.
Why It's Important
CMV is the leading cause of birth defects, and there is an acute need for a vaccine that blocks transmission of the virus from the mother to the fetus.
"These interim data are exciting because mRNA-1647 has shown the ability to induce immune responses in seronegative individuals that are greater than what is seen in those naturally infected with CMV, which is important in that natural immunity is not completely protective against congenital CMV transmission," Sallie Permar, a pediatric immunologist and microbiologist at the Duke Medical School, said in a statement.
Moderna said it is advancing mRNA-1647 to a dose-confirmation Phase 2 study in the near term. The study will test nanoparticles used in this Phase 1 study.
The company is also prepping for a pivotal Phase 3 study designed to evaluate the efficacy of mRNA-1647 against primary CMV infection.
Moderna shares, which debuted on the public market late last year, have pulled back from their intraday high of $29.79 reached on April 8.
The stock was trading higher by 13.88% at $18.13 at the time of publication Thursday.
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