Moderna regains rights to adult RSV vaccine
program from Merck
Start of Phase 1 dosing for mRNA-1345,
Moderna’s vaccine candidate against RSV
Moderna has consolidated all rights to its
prophylactic vaccines portfolio
Conference call to be held on Thursday, October
8 at 8:00 a.m. ET
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines to create a new
generation of transformative medicines for patients, today
announced that it has regained all rights to the respiratory
syncytial virus (RSV) vaccine (mRNA-1172) from Merck, known as MSD
outside the United States and Canada, including rights to develop
RSV vaccines for adult populations. mRNA-1172, which uses a Merck
lipid nanoparticle for delivery, entered Phase 1 development in
2019. Under the terms of the agreement, Merck will complete the
Phase 1 study and transition the program to Moderna. Moderna has
now consolidated all global commercial rights to all development
candidates in its core prophylactic vaccines modality.
Among its RSV candidates, Merck decided to focus its efforts on
RSV infections through its antibody program that is currently in
Phase 2 development.
Separately, Moderna also announced the initiation of dosing in
the Phase 1 study of its solely owned RSV vaccine candidate
(mRNA-1345). This Phase 1 study includes initial dosing in adults,
followed by age de-escalation into children. The company previously
announced its intent to advance mRNA-1345 in children in
combination with mRNA-1653, a vaccine against two other pediatric
respiratory viruses (hMPV, PIV3) which is currently in its own age
de-escalation study. With today’s announcement, Moderna will have
the right to also advance RSV vaccines in adults, either alone or
in combination with other respiratory virus vaccines.
Moderna’s mRNA-1345 vaccine uses the Company’s proprietary lipid
nanoparticle delivery technology also used in the Company’s
COVID-19 vaccine (mRNA-1273) and CMV vaccine (mRNA-1647).
Moderna and Merck will continue their ongoing collaboration in
cancer vaccines. In 2016, Moderna and Merck entered into a
collaboration for mRNA-4157, a personalized cancer vaccine
candidate, which is currently being evaluated in a Phase 2 study.
In 2018, the companies expanded the collaboration to include the
development and commercialization of mRNA-5671 a mutant KRAS
vaccine candidate currently in a Phase 1 study.
“We appreciate the collaboration with Merck to date and we are
pleased to continue advancing our RSV vaccine (mRNA-1345), which
uses our proprietary delivery technology,” said Stéphane Bancel,
Moderna’s Chief Executive Officer. “With this portfolio
consolidation, we will continue to pursue RSV vaccines to protect
the most vulnerable populations – young children and older adults.
With our investments in science and manufacturing, we have taken
eleven infectious disease vaccines into human clinical trials. The
technology used in our core prophylactic vaccines modality has
allowed us to accelerate research and development timelines and
advance our mRNA vaccines into new areas of high unmet need. We
look forward to continuing our productive relationship with Merck
to advance our novel mRNA-based cancer vaccines.”
Conference Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00
a.m. ET on Thursday, October 8, 2020. To access the live conference
call, please dial 866-922-5184 (domestic) or 409-937-8950
(international) and refer to conference ID 5596196. A webcast of
the call will also be available under “Events and Presentations” in
the Investors section of the Moderna website at
investors.modernatx.com. The archived webcast will be available on
Moderna’s website approximately two hours after the conference
call.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines
modality to prevent infectious diseases. Across Moderna’s pipeline,
more than 30,000 healthy volunteers and patients have been enrolled
in Moderna’s clinical studies, including the Phase 3 study of
mRNA-1273. Clinical data demonstrate that Moderna’s proprietary
vaccine technology has been generally well-tolerated and can elicit
durable immune responses to viral antigens. Based on clinical
experience across Phase 1 studies, the company designated
prophylactic vaccines a core modality and is working to accelerate
the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic
vaccines include the ability to combine multiple mRNAs into a
single vaccine, rapid discovery to respond to emerging pandemic
threats and manufacturing agility derived from the platform nature
of mRNA vaccine design and production. Moderna has built a fully
integrated manufacturing plant which enables the promise of the
technology platform.
Moderna currently has nine development candidates in its
prophylactic vaccines modality, including:
Vaccines against respiratory infections
- Respiratory syncytial virus (RSV) vaccine for older adults
(mRNA-1777 and mRNA-1172)
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus (hMPV) and parainfluenza virus type 3
(PIV3) vaccine (mRNA-1653)
- COVID-19 vaccine (mRNA-1273)
- Influenza H7N9 vaccine (mRNA-1851)
Vaccines against infections transmitted from mother to baby
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
- Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts
for eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya
virus, hMPV/PIV3, CMV, Zika and COVID-19). Moderna’s CMV vaccine is
currently in a Phase 2 dose-confirmation study. Moderna’s
investigational Zika vaccine (mRNA-1893), currently in a Phase 1
study, was granted FDA Fast Track designation in August 2019.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients. mRNA medicines
are designed to direct the body’s cells to produce intracellular,
membrane or secreted proteins that can have a therapeutic or
preventive benefit and have the potential to address a broad
spectrum of diseases. The company’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing Moderna the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases and cardiovascular diseases,
independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has
strategic alliances for development programs with AstraZeneca PLC
and Merck & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense, and the Biomedical Advanced Research and Development
Authority (BARDA), a division of the Office of the Assistant
Secretary for Preparedness and Response (ASPR) within the U.S.
Department of Health and Human Services (HHS). Moderna has been
named a top biopharmaceutical employer by Science for the past five
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 statements regarding: plans for the
completion of the Phase 1 study of mRNA-1172 and the transition of
the program to Moderna; the Phase 1 de-escalation study for
mRNA-1345 and Moderna’s plans to produce a combination vaccine for
RSV, HMPV and PIV3; plans for the expansion of Moderna’s RSV
program into the older adult population; and plans to continue
collaborating with Merck on mRNA-based cancer vaccines. 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:
preclinical and clinical development is lengthy and uncertain,
especially for a new class of medicines such as mRNA, and therefore
our preclinical programs or development candidates may be delayed,
terminated, or may never advance to or in the clinic; no commercial
product using mRNA technology has been approved and may never be
approved; mRNA drug development has substantial clinical
development and regulatory risks due to the novel and unprecedented
nature of this new class of medicines; 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; the fact that the rapid response
technology in use by Moderna is still being developed and
implemented; potential adverse impacts due to the global COVID-19
pandemic such as delays in clinical trials, preclinical work,
overall operations, regulatory review, manufacturing and supply
chain interruptions, adverse effects on healthcare systems and
disruption of the global economy; and those 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201008005246/en/
Media: Colleen Hussey Director, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
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