Phase 1/2 study is expected to enroll 200 adults in Japan
Moderna Inc. (Nasdaq: MRNA), a biotechnology company that pioneered messenger RNA (mRNA) and vaccines, today announced the first participant in the Phase 1/2 study of Moderna’s vaccine candidate against COVID-19 (mRNA-1273 ) has been administered. or TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd. (NYSE: TAK). TAK-919 is Takeda’s development code for Moderna’s COVID-19 vaccine candidate.
“We are delighted that this Phase 1/2 study of our COVID-19 vaccine in healthy adults in Japan has begun. This is the first clinical trial of a Moderna product in Japan and we thank Takeda for collaborating with us. to protect the Japanese possible population of COVID-19 with a vaccine, “said Stéphane Bancel, CEO of Moderna.
It placebo-managed Phase 1/2 study will evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 28 days apart. Takeda aims to enroll 200 participants 20 years and older in Japan. Each participant is assigned to receive a placebo or a dose of 100 μg in both vaccinations. Participants will be followed 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 COVID-19 vaccine candidate from the first half of 2021, pending license in Japan.
About Modern
In the ten years since its inception, Moderna has switched from a scientific research stage that advances programs in the promising but still unproven field of messenger RNA (mRNA), to a company with its first medicine that has treated millions of people, a diverse clinical portfolio of vaccines and therapies across six modalities, a broad portfolio of intellectual property in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables large-scale clinical and commercial production at unprecedented speeds . Modern holds alliances with a wide range of local and overseas government and commercial collaborators, enabling cutting-edge science and the rapid scale of manufacturing. Recently, the capabilities of Moderna combined to enable the permitted use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. . There are currently 24 development programs in these therapeutic areas, with 13 programs entering the clinic. Moderna has been named the best bio-pharmaceutical employer by Science for the past six years. Visit www.modernatx.com for more information.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995, as amended, including the conduct of clinical studies of the COVID-19 vaccine candidate from Moderna in Japan and the sale and distribution of the vaccine. in Japan. . In some cases, forward-looking statements can be identified by terminology such as “will,” “power,” “must,” “could”, “expect,” “intend,” “plan,” “aim,” “expect,” ” believe, “” estimate, “” predict, “” potential, “” continue “, or the negatives of these terms or other similar terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are not promises or guarantees, and you should not rely unnecessarily 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 may lead to them. that actual results differ materially from the results expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include: the fact that there has never been a commercial product that uses mRNA technology for approval; the fact that the rapid response technology used by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 vaccine observed so far may adversely change in continuous analyzes of trial data or after commercialization; despite constant interaction with the FDA or other regulatory agencies, the FDA or such regulatory agencies may not agree with the company’s approval strategies, components of our submissions, such as the design of clinical trials, behaviors and methodologies, or the sufficient information that submitted. ; Moderna may experience delays in reaching timelines for the manufacture or delivery of distribution plans for the Moderna COVID-19 vaccine; or and when any applications for biological licenses and / or applications for emergency permits can be submitted and finally approved by regulatory authorities; potential adverse effects due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain disruptions, adverse health care systems and disruption of the world 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 in subsequent submissions Moderna made to the SEC made available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or reviewing 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 the current expectations of Moderna and speak only at the date hereof.
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