RCS - Moderna Inc - Moderna Announces Global Regulatory Submissions

ModernaAnnouncement

05/07/2023 12:00

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RNS Number : 9355E  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
(https://investors.modernatx.com/news/news-details/2023/Moderna-Granted-FDA-Breakthrough-Therapy-Designation-for-mRNA-1345-An-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Candidate/default.aspx#:~:text=The%20designation%20was%20based%20on,Chief%20Executive%20Officer%20of%20Moderna.)
for the prevention of RSV-LRTD in adults aged 60 years or older, and mRNA-1345
was previously granted Fast Track designation
(https://investors.modernatx.com/news/news-details/2021/Moderna-Receives-FDA-Fast-Track-Designation-for-Respiratory-Syncytial-Virus-RSV-Vaccine-mRNA-1345/default.aspx#:~:text=CAMBRIDGE%2C%20Mass.%20--%20%28BUSINESS%20WIRE%29--Aug.%203%2C%202021--%20Moderna%2C,in%20adults%20older%20than%2060%20years%20of%20age.)
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
(https://pr.report/QXduK87f) . 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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