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Phase 1/2 study set to recruit 200 adult participants in Japan
Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapies and vaccines, today announced that the first participant has been assayed in the Phase 1 study / 2 of Moderna’s vaccine candidate 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 Moderna’s COVID-19 vaccine candidate.
“We are pleased that this Phase 1/2 study of our COVID-19 vaccine in healthy adults in Japan has started. This is the first clinical trial of a Moderna product in Japan and we thank Takeda for partnering with us to potentially protect the Japanese. COVID-19 population with a vaccine, ”said Stéphane Bancel, CEO of Moderna.
This placebo controlled Phase 1/2 study will assess the safety and immunogenicity of two mRNA-1273 vaccinations 28 days apart. Takeda intends to register 200 participants aged 20 and over in Japan. Each participant will receive a placebo or a dose of 100 μg during both vaccinations. Participants will be followed for 12 months after the second vaccination. The ClinicalTrials.gov identifier is NCT04677660.
Takeda and Moderna before announced that Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate from the first half of 2021, pending approval in Japan.
About Moderna
In the 10 years since its inception, Moderna has grown from a company in the scientific research stage advancing programs in the promising but still unproven field of messenger RNA (mRNA), to a company with its first drug to treat millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad portfolio of intellectual property in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables large-scale clinical and commercial production at unprecedented speed. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has allowed the pursuit of both groundbreaking science and rapid scale up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the oldest 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. Today, 24 development programs are underway in these therapeutic areas, with 13 programs entering the clinic. Moderna has been named one of Science’s Top Biopharmaceutical Employers 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 of clinical studies of Moderna’s COVID-19 vaccine candidate in Japan and the sale and distribution of the vaccine. in Japan . In some cases, forward-looking statements may be identified by words such as “will”, “may,” “should”, “could”, “expects”, “intends”, “plans”, “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 such forward-looking statements as they involve known and unknown risks, uncertainties and other factors, many of which are beyond the control of Moderna 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: the fact that there has never been a commercial product using mRNA technology approved for use; the fact that the rapid response technology used by Moderna is still under development and implementation; the safety, tolerability and efficacy profile of Moderna COVID-19 vaccine observed to date may change unfavorably in ongoing analyzes of trial data or post-marketing; 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; Moderna may experience delays in meeting manufacturing or supply deadlines or interruptions in its distribution plans for the Moderna COVID-19 vaccine; whether and when biologic license applications and / or emergency use authorization requests can be made and ultimately approved by regulatory authorities; potential negative impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain disruptions, adverse effects on health systems and disruption 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 United States Securities and Exchange Commission (SEC) and in subsequent filings made 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.
See the source version on businesswire.com: https://www.businesswire.com/news/home/20210121005555/en/
Contacts
Moderna contacts
Media:
Colleen Hussey
Director, Corporate Communications
617-335-1374
[email protected]
Investors:
Lavina Talukdar
Senior Vice President and Head of Investor Relations
617-209-5834
[email protected]
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