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<\/p>\n\n\n\n

Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus<\/h1>\n\n\n\n

May 18, 2020 at 7:30 AM EDTPDF Version<\/a><\/p>\n\n\n\n

After two doses all participants evaluated to date across the 25 \u00b5g and 100 \u00b5g dose cohorts seroconverted with binding antibody levels at or above levels seen in convalescent sera<\/em><\/p>\n\n\n\n

mRNA-1273 elicited neutralizing antibody titer levels in all eight initial participants across the 25 \u00b5g and 100 \u00b5g dose cohorts, reaching or exceeding neutralizing antibody titers generally seen in convalescent sera<\/em><\/p>\n\n\n\n

mRNA-1273 was generally safe and well tolerated<\/em><\/p>\n\n\n\n

mRNA-1273 provided full protection against viral replication in the lungs in a mouse challenge model<\/em><\/p>\n\n\n\n

Anticipated dose for Phase 3 study between 25 \u00b5g and 100 \u00b5g; expected to start in July<\/em><\/p>\n\n\n\n

Conference call to be held on Monday, May 18 at 8:30 a.m. ET<\/em><\/p>\n\n\n\n

CAMBRIDGE, Mass.–(BUSINESS WIRE)–May 18, 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 positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).<\/p>\n\n\n\n

Immunogenicity data are currently available for the 25 \u00b5g and 100 \u00b5g dose level (ages 18-55) after two doses (day 43) and at the 250 \u00b5g level (ages 18-55) after one dose (day 29). Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 \u00b5g and 100 \u00b5g dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 \u00b5g dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 \u00b5g dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.<\/p>\n\n\n\n

At this time, neutralizing antibody data are available only for the first four participants in each of the 25 \u00b5g and 100 \u00b5g dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.<\/p>\n\n\n\n

mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. The sole incidence of a grade 3 adverse event in the 25 \u00b5g and 100 \u00b5g dose cohorts was a single participant at 100 \u00b5g who experienced grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 \u00b5g dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.<\/p>\n\n\n\n

Preclinical results from a viral challenge study in mice conducted in collaboration with NIAID and its academic partners are also available. In this study, vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2. Neutralizing titers in Phase 1 clinical trial participants at the 25 \u00b5g and 100 \u00b5g dose levels were consistent with neutralizing titers that were protective in the mouse challenge model.<\/p>\n\n\n\n

Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 \u00b5g and 100 \u00b5g, with the aim of selecting a dose for pivotal studies. The NIAID-led Phase 1 study is being amended to include a 50 \u00b5g dose level cohort across each of the three age groups. Moderna anticipates the dose for the Phase 3 study to be between 25 \u00b5g and 100 \u00b5g and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.<\/p>\n\n\n\n

\u201cThese interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 \u00b5g,\u201d said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. \u201cWhen combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.\u201d<\/p>\n\n\n\n

\u201cWith today\u2019s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA,\u201d said St\u00e9phane Bancel, Chief Executive Officer at Moderna. \u201cWe are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.\u201d<\/p>\n\n\n\n

Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273 and will also support the execution of these studies, as well as the scale-up of mRNA-1273 manufacturing both at the Company\u2019s facilities and that of its strategic collaborator, Lonza Ltd.<\/p>\n\n\n\n

Conference Call and Webcast Information<\/strong><\/p>\n\n\n\n

Moderna will host a live conference call and webcast at 8:30 a.m. ET on Monday, May 18, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 2186342. A webcast of the call will also be available under \u201cEvents and Presentations\u201d in the Investors section of the Moderna website at investors.modernatx.com<\/a>. The archived webcast will be available on Moderna\u2019s website approximately two hours after the conference call.<\/p>\n\n\n\n

About mRNA-1273<\/strong><\/p>\n\n\n\n

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.<\/p>\n\n\n\n

On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Company\u2019s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. On May 12, the FDA granted mRNA-1273 Fast Track designation. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in July 2020. A summary of the company\u2019s work to date on SARS-CoV-2 can be found here<\/a>.<\/p>\n\n\n\n

About Moderna\u2019s Prophylactic Vaccines Modality<\/strong><\/p>\n\n\n\n

Moderna scientists designed the company\u2019s prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Moderna\u2019s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Moderna\u2019s 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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Moderna currently has nine development candidates<\/a> in its prophylactic vaccines modality, including:<\/p>\n\n\n\n

Vaccines against respiratory infections<\/em><\/p>\n\n\n\n