Moderna Announces First Participant Dosed in Phase 2/3 Study of its mRNA Respiratory Syncytial Virus (RSV) Vaccine
November 18 2021 - 7:00AM
Business Wire
Moderna expects to enroll approximately 34,000
participants in multiple countries
RSV is a leading cause of severe respiratory
illness in older adults (65+) and young children; there is no
approved vaccine to prevent RSV
RSV illness in older adults results in an
estimated $3 billion in annual medical costs in the U.S. each
year
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced the
first participant has been dosed in the Phase 2/3 study of
mRNA-1345, the Company’s Respiratory Syncytial Virus (RSV) vaccine
candidate. This study is known as ConquerRSV.
“RSV is a respiratory virus that can result in hospitalization
and death in adults over 65 years of age. Yet, RSV illness in older
adults is often under-recognized and there is no vaccine against
it. The start of this international Phase 2/3 study is an important
milestone as we continue to advance mRNA vaccines against
respiratory viruses,” said Stéphane Bancel, Moderna’s Chief
Executive Officer. “We believe that vaccine candidate against RSV
can have a positive impact on public health as RSV represents a
significant unmet global need. In addition, we believe that
combination vaccines against multiple respiratory pathogens can
help ensure that people are fully vaccinated by leading to higher
compliance and better uptake, which may result in a longer-term
benefit to health care systems and protect people from a broader
number of respiratory viruses.”
RSV is a common respiratory virus that generally causes
cold-like symptoms. In the U.S. and areas with similar climates,
RSV infections occur primarily during fall, winter, and spring.
Most people recover in approximately one to two weeks, but RSV can
be serious, especially for young children under 5 years of age and
older adults over 65 years of age. RSV is a leading cause of severe
respiratory illness in older adults and young children. In older
adults, RSV can result in pneumonia and respiratory distress and
represents a substantial burden of illness. In the U.S., RSV causes
approximately 177,000 hospitalizations and 14,000 deaths in adults
65 years and older. Additionally, RSV in older adults results in an
estimated $3 billion in annual medical costs in the U.S. each year.
RSV is also the most common cause of bronchiolitis and pneumonia in
children younger than one year of age in the U.S. RSV leads each
year, on average, to approximately 58,000 hospitalizations among
children younger than five years. There is no approved vaccine
available today for RSV.
Moderna’s mRNA vaccine portfolio includes candidates against
respiratory viruses, candidates against tropical viruses, and
candidates against latent viruses. In Moderna’s respiratory virus
vaccine program, in addition to its RSV vaccine candidate, the
Company is advancing COVID-19 booster vaccine candidates and a
seasonal flu vaccine candidate (mRNA-1010). At Moderna’s annual
R&D Day in September, the Company announced that it is
developing a single dose vaccine that combines a booster against
COVID-19 and a booster against flu. The Company is also advancing a
combination vaccine candidate against human metapneumovirus and
parainfluenza virus 3 (hMPV/PIV3) and a combination vaccine
candidate against both pediatric RSV and hMPV. In preclinical
studies, Moderna has observed that its seasonal flu, RSV and
COVID-19 booster vaccines can be combined into one dose that
produces an immune response to all six antigens1. Moderna intends
to explore vaccine combinations including RSV, Flu and
COVID-19.
mRNA-1345 is a vaccine against RSV encoding for a prefusion F
glycoprotein, which elicits a superior neutralizing antibody
response compared to the postfusion state. mRNA-1345 uses the same
lipid nanoparticle (LNP) as Moderna’s COVID-19 vaccine and contains
optimized protein and codon sequences. The FDA has granted Fast
Track designation for mRNA-1345 in adults older than 60 years of
age.
The Company recently shared interim data Phase 1 study of
mRNA-1345 in older adults ages 65-79 years. Neutralizing antibodies
were confirmed to be present at baseline in all participants, as
expected. The data showed that a single mRNA-1345 vaccination of 50
µg, 100 µg or 200 µg boosted neutralizing antibody titers against
RSV-A by approximately 14-fold and against RSV-B by approximately
10-fold. Data were pooled across dose levels because there was not
a significant difference between doses. A single vaccination of 50
µg, 100 µg or 200 µg was well-tolerated in older adults through
month one.
The Phase 2/3, randomized, observer-blind, placebo-controlled,
multicenter study will be conducted in multiple countries. Moderna
is choosing study locations based on the ongoing epidemiology of
RSV. The study is known as ConquerRSV. The primary purpose of the
Phase 2 segment of the study is to evaluate the safety of mRNA-1345
vaccine in adults older than 60 years of age for initiation of the
large‑scale Phase 3 segment of the study. The primary purpose of
the Phase 3 segment of the study is to establish the safety and
efficacy of mRNA-1345 vaccine in adults older than 60 years of age
in support of licensure. Moderna expects to enroll approximately
34,000 participants. To learn more about eligibility, please click
here.
About Moderna
In 10 years since its inception, Moderna has transformed from a
science 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 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 autoimmune diseases. Moderna has been named a top
biopharmaceutical employer by Science for the past seven 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 Company’s development of
a vaccine candidate against respiratory syncytial virus (RSV)
(mRNA-1345); the ability of mRNA-1345 to induce neutralizing
antibodies against RSV in older adults; the safety profile and
tolerability of mRNA-1345; the ability of mRNA-1345 to reduce RSV
infections in older adults; the conduct of Phase 2/3 clinical
trials for mRNA-1345; the potential for the Company to produce and
commercialize combination vaccines; the disease burden and costs
associated with RSV infection; and the Company’s development of
vaccine candidates against other respiratory diseases, including
seasonal flu and COVID-19. 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 most recent Annual Report on Form 10-K 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.
1
https://investors.modernatx.com/static-files/3c4e5f0c-cfd2-48e5-8c41-4554eef30b7e
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version on businesswire.com: https://www.businesswire.com/news/home/20211118005257/en/
Moderna 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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