Phase 1/2 study expected to involve 200 adult participants in Japan
Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) vaccines and therapies, announced today that the first participant was dosed in the Phase 1/2 study of the modern candidate vaccine against COVID-19 (mRNA -1273 or TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd (NYSE: TAK). TAK-919 is Takeda’s development code for the vaccine candidate COVID-19 from Moderna.
“We are pleased with the start of this Phase 1/2 study of our COVID-19 vaccine in healthy adults in Japan. This is the first clinical trial of a Moderna product in Japan and we thank Takeda for its partnership with us to potentially protect the Japanese population of COVID-19 with a vaccine, “said Stéphane Bancel, CEO of Moderna.
This one placebo controlled Phase 1/2 study will assess the safety and immunogenicity of two mRNA-1273 vaccinations 28 days apart. Takeda plans to enroll 200 participants aged 20 years or older in Japan. Each participant will be assigned to receive either a placebo or a 100 μg dose for both vaccinations. Participants will be followed for 12 months after the second vaccination. The ClinicalTrials.gov identifier is NCT04677660.
Takeda and Moderna previously announced that Takeda will import and distribute 50 million doses of Moderna’s candidate vaccine COVID-19 from the first half of 2021, with a pending license in Japan.
About Moderna
In 10 years since its inception, Moderna has transformed itself from a company in the stage of scientific research that advances programs in the promising, but not yet proven, messenger RNA (mRNA) field, into a company with its first medicine having treated millions of people , a diversified clinical portfolio of vaccines and therapies in six modalities, a broad portfolio of intellectual property in areas, including mRNA and formulation of lipid nanoparticles, and an integrated manufacturing plant that allows clinical and commercial production at an unprecedented scale and speed. Moderna maintains alliances with a wide range of domestic and foreign commercial and government employees, which has enabled the search for innovative science and the rapid increase in production. More recently, Moderna’s capabilities have come together to allow the authorized use of one of the oldest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform is based on continuous advances in basic and applied mRNA science, delivery and manufacturing technology, and has enabled the development of therapeutics and vaccines for infectious diseases, immunoncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today, 24 development programs are underway in these therapeutic areas, with 13 programs entering the clinic. Moderna has been named one of the top biopharmaceutical employers by Science for the past six years. To learn more, visit www.modernatx.com.
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 regarding the conduct for clinical studies of Moderna’s candidate vaccine COVID-19 in Japan and the sale and distribution of the vaccine in Japan . In some cases, forward-looking statements may be identified by terminology such as “will”, “may”, “should”, “could”, “wait”, “intend”, “plan”, “visa”, “anticipate,” ” believes, “” estimates, “” predicts “,” potential “,” continues “or the negative of these terms or other comparable terminology, although not all forward-looking statements contain those words. The forward-looking statements in this press release are not promises or guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Moderna’s control and what you could do with that actual results differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include, among others: the fact that there has never been a commercial product using mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still under development and implementation; the safety, tolerability and efficacy profile of the Modern Vaccine COVID-19 observed to date may change adversely in the ongoing analysis of the trial data or after commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our files, such as clinical trial designs, conduct and methodologies, or the sufficiency of data presented; Moderna may encounter delays in meeting manufacturing or supply schedules or interruptions in its distribution plans for the Modern Vaccine COVID-19; if and when any applications for licenses for biological products and / or applications for authorization for emergency use can be filed and finally approved by regulatory authorities; potential adverse impacts due to the global pandemic COVID-19, such as delays in regulatory review, manufacturing and clinical testing, supply chain disruptions, adverse effects on health systems and disruption to the global economy; and the other risks and uncertainties described under the heading “Risk factors” in Moderna’s most recent quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and 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 for updating or revising 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 are only valid as of the date of this document.
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