Moderna Completes Enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)
Cohorts of younger adults (n=300) and older adults (n=300) in Phase 2 study fully enrolled
Cohorts of older adults (ages 56-70, n=30) and elderly?adults (ages 71 and above, n=30) in NIH-led Phase 1 study completed enrollment; results expected to be published once available
Pivotal Phase 3 study expected to begin in July; manufacture of vaccine required to start Phase 3 study completed
July 08, 2020 09:44 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 it has completed enrollment for both cohorts of the Phase 2 study of its vaccine candidate (mRNA-1273) against COVID-19. mRNA-1273 is Moderna?s second mRNA vaccine for an infectious disease to complete enrollment of a Phase 2 study, following the Company?s?CMV Phase 2 study, which was fully enrolled on March 3, 2020.
On June 11, 13 days after the first participant was dosed, the Company?announced?that the cohort of healthy younger adults ages 18-55 (n=300) and the sentinel group of older adults ages 55 years and above (n=50) in the?Phase 2 study?of mRNA-1273 was complete. After reviewing the safety data from the sentinel cohort of older adults, on June 25, the Data and Safety Monitoring Committee of the study recommended Moderna to proceed with enrollment for the remainder of the Phase 2 study. The cohort of older adults (n=300) has now been fully enrolled. This Phase 2 placebo-controlled, dose-confirmation study is evaluating the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each participant is receiving placebo, a 50 ?g or a 100 ?g dose at both vaccinations. The Company also announced that the cohorts of older adults (ages 56-70, n=30) and elderly adults (ages 71 and above, n=30) in NIH-led?Phase 1 study?have completed enrollment. Results are expected to be published once available. ?I would like to thank the healthy volunteer participants, our partners at clinical trial sites and the dedicated Moderna team for their support in completing enrollment of the Phase 2 study of mRNA-1273, our vaccine candidate against COVID-19,? said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. ?We are committed to helping address this ongoing public health emergency and continue to focus on our Phase 3 study, which remains on track to start in July, less than seven months from the sequencing of the virus.? Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 ?g dose level in the U.S. and is expected to be conducted in collaboration with NIAID, subject to regulatory approval. Moderna has completed manufacture of vaccine required to start the Phase 3 study. With the Phase 3 dose at 100 ?g, the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company?s internal U.S. manufacturing site and strategic collaboration with Lonza. In addition, Moderna recently?announced?a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent?s biologics facility in Indiana. About mRNA-1273 mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a?prefusion stabilized?form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. About Moderna?s Prophylactic Vaccines Modality Moderna scientists designed the company?s prophylactic vaccines modality to prevent infectious diseases. More than 1,600 participants have been enrolled in Moderna?s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Moderna?s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline. The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine 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. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform. Moderna currently has?nine development candidates?in its prophylactic vaccines modality, including: Vaccines against respiratory infectionsModerna completes enrollment of Phase 2 study of its mRNA vaccine against COVID-19 (mRNA-1273)
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- Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
- COVID-19 vaccine (mRNA-1273)
- Influenza H7N9 (mRNA-1851)
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
- Zika vaccine (mRNA-1893 with BARDA)
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)