Moderna’s Positive Phase 1 Readouts of mRNA Vaccine Candidates Indicate Potential for Coronavirus Prevention

(Cambridge, MA, USA) hosted its first Vaccines Day on April 14, including presentations highlighting the potential advantages of messenger RNA (mRNA) vaccines, and also announced new positive interim Phase 1 data from its Zika vaccine candidate (mRNA-1893). With this data, Moderna’s prophylactic vaccines modality now has seven positive Phase 1 readouts, including a combination vaccine against two viruses (hMPV and PIV3; mRNA-1653). The company has demonstrated neutralizing immunogenicity against all eight viruses targeted to date in its clinical trials. Based on the totality of this clinical experience, earlier this year the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.

mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna has 24 mRNA development candidates in its portfolio across all modalities, with 13 in clinical studies. Five of these programs are in or preparing for Phase 2 studies and the company is preparing for its first Phase 3 study.

Moderna’s vaccine pipeline has been studied in 10 clinical trials to date with more than 1,400 participants. Clinical data demonstrates that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. The company also believes that it has demonstrated the ability to leverage shared technology, digital systems and a flexible manufacturing infrastructure to advance a large portfolio quickly and efficiently. To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccine candidates, which include H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, Cytomegalovirus (CMV) and Zika. Moderna’s CMV vaccine candidate is currently in a Phase 2 dose-confirmation study.

“We believe that our seven innovative first-in-class mRNA vaccine candidates provide a strong foundation for Moderna and offer a high probability of success when compared to other technologies. In the last several decades, 80 new pathogens have emerged, yet the vast majority of these viruses lack an approved vaccine in the U.S. We believe that vaccines offer a large total addressable market and an opportunity to reduce healthcare costs with a benefit to society through the prevention of devastating illnesses in areas of unmet need,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “The totality of data from our vaccines platform gives us reason to be optimistic about the prospects for our vaccines to come, including our vaccine against the novel coronavirus.”

“I am encouraged by these interim Phase 1 data showing the ability of mRNA-1893 to elicit a strong neutralizing antibody response,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “Our Zika program, along with our continued work on a vaccine candidate against the novel coronavirus, underscore our commitment to improving global public health through developing mRNA vaccines to prevent the spread of infectious diseases.”

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