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CAMBRIDGE, Mass .– (BUSINESS WIRE) – Moderna, Inc., (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapies and vaccines to create a new generation of transformative drugs for patients, announced today hui that it has completed case counting for the first interim analysis of the COVE Phase 3 study of mRNA-1273, its COVID-19 vaccine candidate.
Moderna has seen a significant increase in the rate of case identification across all sites over the past week. As a result, the company expects that the first interim scan will include significantly more than 53 cases, the targeted trigger point for the scan. Data on these cases are being prepared for submission to the Independent Data Security Oversight Board (DSMB) for analysis and recommendation. Moderna does not know whether these participants received a vaccine or a placebo.
On October 22, the COVE Phase 3 mRNA-1273 study completed the recruitment of 30,000 participants in the United States. The randomized 1: 1, placebo-controlled phase 3 trial studies mRNA-1273 at a dose of 100 µg. The primary endpoint is prevention of symptomatic disease of COVID-19. Primary secondary endpoints include prevention of severe COVID-19 illness and prevention of SARS-CoV-2 infection. The ClinicalTrials.gov identifier is NCT04470427.
The Phase 3 study was designed in collaboration with the FDA and NIH to assess Americans most at risk of developing severe COVID-19 disease and included more than 7,000 Americans over 65. age 65, but have high-risk chronic conditions that put them at increased risk for severe COVID-19, such as diabetes, severe obesity and heart disease. These high medical risk groups represent 42% of the total participants in the Phase 3 COVE study. Moderna has also worked to develop a vaccine for everyone, including communities that have been historically under-represented in clinical research and are disproportionately affected by COVID-19. The study included more than 11,000 participants from communities of color, representing 37% of the study population and similar to the diversity of the United States as a whole. This included over 6,000 participants who identify as Hispanic or LatinX, and over 3,000 participants who identify as black or African American.
About mRNA-1273
MRNA-1273 is a COVID-19 mRNA vaccine encoding a pre-fusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and researchers at the NIAID Vaccine Research Center. The first clinical batch, 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 after sequence selection. The first participant in the Phase 1 study conducted by NIAID on mRNA-1273 received a dose on March 16, 63 days between sequence selection and dosing in the phase 1 study. May 12 , the FDA has granted the Fast Track designation mRNA-1273. On May 29, the first participants of each age cohort: adults aged 18 to 55 (n = 300) and older adults aged 55 and older (n = 300) received a dose in the mRNA-1273 phase 2 study. On July 8, the Phase 2 study completed enrollment.
The results of the second interim analysis of 1273 mRNA in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, the results of a preclinical viral challenge study in non-human primates evaluating mRNA-1273 were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts of the NIH-1273 mRNA Phase 1 study was published in The New England Journal of Medicine. A summary of the company’s work to date on COVID-19 can be found here.
BARDA supports the continued research and development of mRNA-1273 with federal funding of $ 955 million under contract no. 75A50120C00034. BARDA reimburses Moderna 100% of the eligible costs incurred by the company for the implementation of the program described in the BARDA contract. The US government has pledged $ 1.525 billion to purchase mRNA-1273 under contract # W911QY-20-C-0100 from the US Department of Defense.
Moderna said it expects to be able to produce around 20 million doses of mRNA-1273 in 2020 and 500 million to one billion doses globally in 2021.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements concerning: the development by the Company of a potential vaccine (mRNA-1273) against the novel coronavirus, the number of cases to be included in the first interim analysis of the phase 3 COVE study of mRNA-1273, the potential purchases of mRNA-1273 by the US government and the planned manufacture and supply of mRNA- 1273. In some cases, forward-looking statements may be identified by terminology such as “will”, “may”, “should”, “could”, “expects”, “intends”, “intends”, “aims”. “,” Anticipates, “” Believes “,” estimates “,” predicts “,” potential “,” continue “or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words . The forward-looking statements contained in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements as they involve known and unknown risks, uncertainties and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, but are not limited to: preclinical and clinical development is long and uncertain, especially for a new class of drugs such as mRNA, and therefore our preclinical programs or development candidates may be delayed, interrupted or never advancing to or in the clinic; no commercial product using mRNA technology has been and can never be approved; The development of mRNA drugs presents substantial clinical development and regulatory risks due to the new and unprecedented nature of this new class of drugs; despite ongoing interactions with the FDA or other regulatory agencies, the FDA or these other regulatory agencies may not agree with the company’s regulatory approval strategies, components of our deposits, such as clinical trial designs, conduct and methodologies, or sufficiency of data submitted; the fact that the rapid response technology used by Moderna is still under development and implementation; that the safety and efficacy of mRNA-1273 have not yet been established; potential negative impacts due to the global COVID-19 pandemic such as delays in clinical trials, preclinical work, global operations, regulatory review, manufacturing and supply chain disruptions, effects adverse events on healthcare systems and the disruption of the global economy and other risks and uncertainties described under “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) of the United States and in subsequent filings by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility to update or revise any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
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