Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
April 27, 2020 at 4:30 PM EDT
600 participant Phase 2 study to begin upon IND acceptance and safety data from ongoing?NIH-led Phase 1 study
Planning underway for Phase 3 study; study expected to begin in the fall of 2020
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 27, 2020--?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 submitted an Investigational New Drug (IND) application to the?U.S. Food and Drug Administration?(FDA) for the company?s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2) to evaluate mRNA-1273 in Phase 2 and late-stage studies if supported by safety data from the Phase 1 study led by the?National Institute of Allergy and Infectious Diseases?(NIAID), part of the?National Institutes of Health. Moderna?has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020. This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each subject will be assigned to receive placebo, a 50 ?g or a 250 ?g dose at both vaccinations. The company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Participants will be followed through 12 months after the second vaccination. ?Submitting this IND is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency,? said?Tal Zaks, M.D., Ph.D., Chief Medical Officer at?Moderna. ?We look forward to launching this Phase 2 study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273.? Subject to data from the Phase 1 and Phase 2 studies and discussions with regulators, a Phase 3 study could begin in the fall of 2020.?Funding?from the?Biomedical Advanced Research and Development Authority?(BARDA), part of the?Office of the Assistant?Secretary for Preparedness and Response within the?U.S. Department of Health and Human Services, supported the planning for these studies and also will support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing. ?Safe, effective vaccines are critical to ending this pandemic and preventing future outbreaks of SARS-COV-2,? said BARDA Acting Director?Gary Disbrow, Ph.D. ?The next steps announced today for this particular vaccine highlight the value of collaboration among government agencies including BARDA and NIAID, and the private sector, to move vaccines and other medical countermeasures forward as rapidly as possible.? About the NIAID-led Phase 1 Study An open-label Phase 1 study of mRNA-1273 is being conducted by the?National Institute of Allergy and Infectious Diseases?under its own Investigational New Drug (IND) application. The Phase 1 study, which began on?March 16, 2020, completed enrollment of 45 healthy adult volunteers ages 18 to 55 years in the original three dose cohorts (25 ?g, 100 ?g and 250 ?g). The study is?enrolling?an additional six cohorts: three cohorts of older adults (ages 56-70) and three cohorts of elderly adults (ages 71 and above). Data from the original cohort of healthy adult volunteers ages 18 to 55 years will be reported once available. About mRNA-1273 mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by?Moderna?in collaboration with investigators from?Vaccine Research Center?(VRC) at the?National Institute of Allergy and Infectious Diseases?(NIAID), a part of the?NIH. 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. A summary of the company?s work to date on SARS-CoV-2 can be found?here. About Moderna?s Prophylactic Vaccines Modality Moderna?scientists designed the company?s prophylactic vaccines modality to prevent infectious diseases. More than 1,400 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 infections- 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)
- Novel coronavirus (SARS-CoV-2) 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)
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Moderna Media: Colleen Hussey Senior Manager, Corporate Communications 203-470-5620 Colleen.Hussey@modernatx.com Dan Budwick 1AB 973-271-6085 Dan@1abmedia.com Investors: Lavina Talukdar Head of Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com Source:?Moderna, Inc.