1st CMV Vaccine Candidate To Launch Phase 2 Study

A Massachusetts based biotechnology company announced that the Phase 2 clinical study dose-confirmation study of its messenger RNA vaccine against cytomegalovirus (CMV) is enrolling ahead of plan with data now expected in the third quarter of 2020.

Moderna Inc.’s CMV vaccine candidate mRNA-1647 is the first mRNA vaccine for an infectious disease to enter a Phase 2 study.

The Company is actively preparing for a Phase 3 pivotal study, which will evaluate the prevention of primary CMV infection in a population that includes women of childbearing age.

“I am pleased with the continued progress of our late-stage CMV vaccine program as we prepare for a pivotal Phase 3 study and commercial readiness,” said Stéphane Bancel, Moderna’s Chief Executive Officer, in a related press release.

The potential advantages of an mRNA approach to prophylactic vaccines include the ability to mimic natural infection to stimulate a more potent immune response, combining multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production, says the company.

“I am proud of the team’s ability to rapidly respond to the ongoing public health crisis posed by the novel coronavirus and to be working with the National Institutes of Health and Coalition for Epidemic Preparedness Innovations.”

On January 24, 2020, Moderna announced the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases, would collaborate with Moderna to design a coronavirus messenger RNA (mRNA) vaccine candidate.

Moderna’s mRNA-1273 is an mRNA vaccine candidate against the novel coronavirus encoding for the viral Spike (S) protein. 

The S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome and Severe Acute Respiratory Syndrome.

The first clinical batch of mRNA-1273, including fill and finishing of vials, was completed on February 7, 2020. This mRNA vaccine was designed and manufactured in 25 days and is undergoing analytical testing prior to release to the NIH for use in their planned Phase 1 clinical trial in the U.S. 

This is good news since there are no approved vaccines specific to the 2019-nCoV, as of February 11, 2020.

Moderna has built a fully integrated manufacturing plant in Norwood, MA which enables the promise of the technology platform.

Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients. Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc., Merck, Inc., as well as the Defense Advanced Research Projects Agency, an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority, a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Vaccine Development news is published by Precision Vaccinations.