Moderna Announces First Participant Dosed in Phase 1/2 Study of Moderna COVID-19 Vaccine in Japan Led by Takeda
January 21 2021 - 9:00AM
Business Wire
Phase 1/2 study expected to enroll 200 adult
participants in Japan
Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that the first participant has been dosed in the Phase 1/2 study 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 begun. 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
population from COVID-19 with a vaccine,” said Stéphane Bancel,
Chief Executive Officer of Moderna.
This placebo-controlled
Phase 1/2 study will
evaluate the safety and immunogenicity of two vaccinations of
mRNA-1273 given 28 days apart. Takeda intends to enroll 200
participants aged 20 years and above in Japan. Each participant
will be assigned to receive a placebo or a 100 μg dose at both
vaccinations. Participants will be followed through 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 starting in the first
half of 2021, pending licensure in Japan.
About Moderna
In 10 years since its inception, Moderna has transformed from a
science research-stage company advancing programs in the
promising-but-still-unproven field of messenger RNA (mRNA), to an
enterprise with its first medicine having treated millions of
people, a diverse clinical portfolio of vaccines and therapeutics
across six modalities, a broad intellectual property portfolio in
areas including mRNA and lipid nanoparticle formulation, and an
integrated manufacturing plant that allows for both clinical and
commercial production at scale and at unprecedented speed. Moderna
maintains alliances with a broad range of domestic and overseas
government and commercial collaborators, which has allowed for the
pursuit of both groundbreaking science and rapid scaling of
manufacturing. Most recently, Moderna’s capabilities have come
together to allow the authorized 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 allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases and auto-immune diseases. Today, 24 development programs
are underway across these therapeutic areas, with 13 programs
having entered the clinic. Moderna has been named a top
biopharmaceutical employer 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 COVID-19 vaccine candidate 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,” “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 in this press
release are neither promises nor 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 which could
cause actual results to 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 utilizing mRNA
technology approved for use; the fact that the rapid response
technology in use by Moderna is still being developed and
implemented; the safety, tolerability and efficacy profile of the
Moderna COVID-19 Vaccine observed to date may change adversely in
ongoing analyses of trial data or subsequent to commercialization;
despite having ongoing interactions with the FDA or other
regulatory agencies, the FDA or such other regulatory agencies may
not agree with the Company’s regulatory approval strategies,
components of our filings, such as clinical trial designs, conduct
and methodologies, or the sufficiency of data submitted; Moderna
may encounter delays in meeting manufacturing or supply timelines
or disruptions in its distribution plans for the Moderna COVID-19
Vaccine; whether and when any biologics license applications and/or
emergency use authorization applications may be filed and
ultimately approved by regulatory authorities; potential adverse
impacts due to the global COVID-19 pandemic such as delays in
regulatory review, manufacturing and clinical trials, supply chain
interruptions, adverse effects on healthcare systems and disruption
of the global economy; and those 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 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 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 speak only as of the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20210121005555/en/
Moderna Contacts Media: Colleen Hussey Director,
Corporate Communications 617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Senior Vice President & Head of
Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com
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