TIDM0A45
Moderna Inc
05 July 2023
Moderna Announces Global Regulatory Submissions for Its
Respiratory Syncytial Virus (RSV) Vaccine, MRNA-1345
Moderna has submitted marketing authorization applications for
the investigational RSV vaccine, mRNA-1345, with the European
Medicines Agency, Swissmedic, and the Therapeutic Goods
Administration in Australia
The Company has also initiated a rolling submission of a
Biologics License Application to the U.S. Food and Drug
Administration for mRNA-1345
mRNA-1345 met primary efficacy endpoints, demonstrating vaccine
efficacy of 83.7% against RSV lower respiratory tract disease in
older adults in the Phase 3 pivotal efficacy trial, ConquerRSV
The Company plans further regulatory submissions for mRNA-1345
worldwide
CAMBRIDGE, MA / ACCESSWIRE / July 5, 2023 / Moderna, Inc.
(Nasdaq:MRNA), a biotechnology company pioneering messenger RNA
(mRNA) therapeutics and vaccines, today provided an update on
regulatory submissions for mRNA-1345, a vaccine for the prevention
of RSV-associated lower respiratory tract disease (RSV-LRTD) and
acute respiratory disease (ARD) in adults aged 60 years or
older.
The Company has submitted marketing authorization applications
for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic
in Switzerland, and the Therapeutic Goods Administration (TGA) in
Australia and has initiated the rolling submission process for a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for the licensure of the mRNA-based RSV
vaccine.
"We are proud to announce these filings for the use of our RSV
vaccine candidate, mRNA-1345, in the European Union, Switzerland,
Australia, and the U.S. RSV is a major cause of lower respiratory
tract infections in older adults and can cause a significant burden
to health systems through hospitalizations and emergency care
admissions," said Stéphane Bancel, Chief Executive Officer of
Moderna. "Our mRNA platform has allowed us to move from initial
clinical testing to our first international Phase 3 trial to
initiation of regulatory submissions for mRNA-1345 in just two
years, enabling us to tackle this pervasive public health burden
with speed and clinical rigor. mRNA-1345 represents the second
product coming from our mRNA platform to seek global approval, and
with recent positive data in rare disease and cancer, we expect
more in the future - further demonstrating the tremendous potential
of mRNA to combat disease."
The regulatory applications are based on positive data from a
prespecified interim analysis of the pivotal ConquerRSV study, a
randomized, double-blind, placebo-controlled study of approximately
37,000 adults 60 years or older in 22 countries. The primary
efficacy endpoints were based on two definitions of RSV-LRTD,
defined as either two or more symptoms or three or more symptoms of
disease. The trial met both its primary efficacy endpoints, with a
vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%;
p<0.0001) against RSV-LRTD as defined by two or more symptoms,
and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against
RSV-LRTD defined by three or more symptoms. The vaccine was well
tolerated with a favorable safety profile. Most solicited adverse
reactions were mild or moderate, and the most commonly reported
solicited adverse reactions in the mRNA-1345 group were injection
site pain, fatigue, headache, myalgia, and arthralgia. The
ConquerRSV study is ongoing, and additional efficacy analyses are
planned as cases accrue, including for severe RSV. In addition to
older adults, mRNA-1345 is being investigated in a fully enrolled,
ongoing Phase 1 trial in pediatric populations.
In January 2023, the U.S. FDA granted mRNA-1345 Breakthrough
Therapy Designation for the prevention of RSV-LRTD in adults aged
60 years or older, and mRNA-1345 was previously granted Fast Track
designation by the U.S. FDA in August 2021. In Australia, the TGA
submission will be evaluated under the Priority Pathway, following
approval of the Priority Determination application for mRNA-1345 in
April 2023.
Moderna's respiratory disease vaccine pipeline includes Phase 3
trials against influenza and a next-generation COVID-19 candidate.
The pipeline also includes four additional influenza vaccines with
expanded antigens, vaccines against other respiratory pathogens,
and five combination vaccine programs.
About mRNA-1345
mRNA-1345 is an investigational RSV vaccine that consists of a
single mRNA sequence encoding for a stabilized prefusion F
glycoprotein. The vaccine uses the same lipid nanoparticles (LNPs)
as in the Moderna COVID-19 vaccines. The F glycoprotein is on the
surface of the virus and is required for infection by helping the
virus to enter host cells. It exists in two states, prefusion and
postfusion. The prefusion conformation is a significant target of
potent neutralizing antibodies, and the protein sequences are
largely similar across both RSV-A and RSV-B subtypes.
About Moderna
In over 10 years since its inception, Moderna has transformed
from a research-stage company advancing programs in the field of
messenger RNA (mRNA), to an enterprise with a diverse clinical
portfolio of vaccines and therapeutics across seven modalities, a
broad intellectual property portfolio and integrated manufacturing
facilities that allow for rapid clinical and commercial production
at scale. 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 and
approval 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. Moderna has been named a top
biopharmaceutical employer by Science for the past eight years. To
learn more, visit www.modernatx.com.
Moderna 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 regulatory process with
respect to mRNA-1345, including the potential for regulatory
approval; Moderna's plans for further regulatory submissions for
mRNA-1345 worldwide; the efficacy and safety and tolerability
profile of mRNA-1345; the ongoing ConquerRSV study; and Moderna's
expectations regarding future potential products, including in the
areas of rare disease and cancer. 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 those other risks
and uncertainties described under the heading "Risk Factors" in
Moderna's Annual Report on Form 10-K for the fiscal year ended
December 31, 2022, 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 of this press
release.
Moderna Contacts
Media:
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
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