Moderna (MRNA) Completes Enrollment of Cytomegalovirus (CMV) Vaccine (mRNA-1647) Phase 2 Study

Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that enrollment is complete for all three dose cohorts of the Phase 2 dose-confirmation study of its investigational cytomegalovirus (CMV) vaccine (mRNA-1647). mRNA-1647, the first mRNA vaccine for an infectious disease to enter a Phase 2 study, is a wholly owned program in Moderna’s prophylactic vaccines portfolio.

On January 9, the Company announced positive seven-month interim safety and immunogenicity data after the third and final vaccination of the 30, 90, and 180 μg dose level cohorts of the Phase 1 study, which built on the previously reported three-month interim analysis, after two vaccinations. The first interim analysis of the Phase 2 study is expected in the third quarter of 2020.

“I would like to thank the dedicated Moderna CMV team and our partners at clinical trial sites for their support in completing enrollment of the Phase 2 study ahead of plan,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We recognize the urgent need for a preventative vaccine against CMV in women of childbearing age, which we believe positions our wholly owned mRNA-1647 program as a potential blockbuster commercial and clinical opportunity. We believe our CMV vaccine will build Moderna’s future and embodies our mission of creating a new generation of transformative medicines for patients. The Moderna team is working diligently to start the Phase 3 study in 2021.”

The Phase 2 study is evaluating the safety and immunogenicity of mRNA-1647 in 252 healthy adults in the U.S. at three dose levels (50, 100 and 150 μg) in both CMV-seronegative and CMV-seropositive participants administered in a three-dose vaccination schedule (0, 2 and 6 months). The first interim analysis at three months (one month after the second vaccination) is expected in the third quarter of 2020 and is intended to inform Phase 3 dose selection. The Company is actively preparing for a Phase 3 pivotal study expected to start in 2021, which will evaluate prevention of primary CMV infection in a population that includes women of childbearing age.

mRNA-1647 comprises six mRNAs encoding two antigens in one vaccine and is designed to protect against CMV infection. Of the six mRNAs, five encode the subunits of the CMV pentamer complex and one mRNA encodes the glycoprotein B (gB) protein, both of which are highly immunogenic. Both pentamer and gB proteins are essential for CMV to enter epithelial cells, which is the first step in CMV infection. mRNA-1647 is designed to produce an immune response to both pentamer and gB antigens to prevent CMV infection. There is no approved vaccine for CMV.

You May Also Be Interested In

• Ocugen (OCGN) Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 2 of Phase 1/2 ArMaDa Clinical Trial of OCU410—A Modifier Gene Therapy
• Takeda (TAK) U.S. FDA Approves Subcutaneous Administration of ENTYVIO
• Vertex Pharma (VRTX) Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic Pain