Phase 3 study of 30,000 subjects expected to
begin in July 2020 at 100 μg dose level
Manufacturing scale up with Lonza on track to
supply 500 million to 1 billion 100 μg doses per year
Completed enrollment of younger adults in the
Phase 2 study of mRNA-1273 (n=300); also completed enrollment of
the sentinel group of older adults (n=50)
Moderna, Inc., (Nasdaq: MRNA) a clinical stage
biotechnology company pioneering messenger RNA (mRNA) therapeutics
and vaccines to create a new generation of transformative medicines
for patients, today announced progress on late-stage development of
mRNA-1273, the Company’s mRNA vaccine candidate against
COVID-19.
Moderna has finalized the Phase 3 study protocol based on
feedback from the U.S. Food and Drug Administration (FDA). The
randomized, 1:1 placebo-controlled trial is expected to include
approximately 30,000 participants enrolled in the U.S. and is
expected to be conducted in collaboration with the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH). The trial’s primary endpoint
will be the prevention of symptomatic COVID-19 disease; key
secondary endpoints include prevention of severe COVID-19 disease
(as defined by the need for hospitalization) and prevention of
infection by SARS-CoV-2, the virus that causes COVID-19. The
primary efficacy analysis will be an event-driven analysis based on
the number of participants with symptomatic COVID-19 disease. Based
on the results of the Phase 1 study, the 100 μg dose level was
chosen as the optimal dose level to maximize the immune response
while minimizing adverse reactions. Moderna has completed
manufacture of vaccine required to start the Phase 3 study. The
Company expects dosing in the Phase 3 study to begin in July.
With the Phase 3 dose being finalized at 100 μg, the Company
remains on track to be able to deliver approximately 500 million
doses per year, and possibly up to 1 billion doses per year,
beginning in 2021 from the Company’s internal U.S. manufacturing
site and strategic collaboration with Lonza.
“We look forward to beginning our Phase 3 study of mRNA-1273
with some 30,000 participants in July,” said Tal Zaks, M.D., Ph.D.,
Chief Medical Officer at Moderna. “Moderna is committed to
advancing the clinical development of mRNA-1273 as safely and
quickly as possible to demonstrate our vaccine’s ability to
significantly reduce the risk of COVID-19 disease.”
The first cohort of healthy adults ages 18-54 years (n=300) in
the Phase 2 study of mRNA-1273 is fully enrolled, 13 days after the
first participant was dosed. The sentinel participants in the
cohort of older adults ages 55 years and above (n=50) is fully
enrolled. This Phase 2 study, being conducted by Moderna, is
evaluating the safety, reactogenicity and immunogenicity of two
vaccinations of mRNA-1273 given 28 days apart. The Company intends
to enroll 600 healthy participants across two cohorts of adults
ages 18-54 years (n=300) and older adults ages 55 years and above
(n=300). Each participant will be assigned to receive placebo, a 50
μg or a 100 μg dose at both vaccinations. Participants will be
followed through 12 months after the second vaccination.
On May 6, the U.S. Food and Drug Administration (FDA) completed
its review of the Company’s Investigational New Drug (IND)
application for mRNA-1273 and on May 11, the FDA granted it Fast
Track designation. On May 18, Moderna announced initial data from
the Phase 1 study of mRNA-1273 led by NIAID. The Phase 1 study is
ongoing with the original cohorts in long-term follow-up and
enrollment in 9 of 12 cohorts complete. The NIH will be submitting
the Phase 1 data to a peer-reviewed clinical publication.
Funding from 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), partially supported
the planning for the Phase 2 and Phase 3 studies of mRNA-1273 and
is supporting the execution of these studies, as well as the
manufacturing process scale-up of mRNA-1273. Moderna will also fund
costs required to complete the development of mRNA-1273 including
portions of the Phase 3 study and the scale up of manufacturing
capacity at the final established dosage in order to obtain
licensure for mRNA-1273. A summary of the company’s work to date on
COVID-19 can be found here.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a
prefusion stabilized form of the Spike (S) protein, which was
selected by Moderna in collaboration with investigators from
Vaccine Research Center (VRC) at the National Institute of Allergy
and Infectious Diseases (NIAID), a part of the NIH. The first
clinical batch, which was funded by the Coalition for Epidemic
Preparedness Innovations, was completed on February 7, 2020 and
underwent analytical testing; it was shipped to NIH on February 24,
42 days from sequence selection. The first participant in the
NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days
from sequence selection to Phase 1 study dosing.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines
modality to prevent infectious diseases. More than 1,600
participants have been enrolled in Moderna’s infectious disease
vaccine clinical studies under health authorities in the U.S.,
Europe and Australia. 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 or V172 with Merck)
- 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 (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 seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya
virus, hMPV/PIV3, CMV and Zika). 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, cardiovascular diseases, and
autoimmune and inflammatory 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 BARDA. 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 regarding the Company’s development of
a potential vaccine against the novel coronavirus, the parameters
and timing of the Phase 2 and planned Phase 3 studies of mRNA-1273,
the Company’s potential manufacturing capabilities and projected
vaccine dose production, the submission of Phase 1 data for
publication, and costs related to the mRNA-1273 program to be
funded by the Company. 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 fact that the safety and
efficacy of mRNA-1273 has not yet been established; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200611005456/en/
Moderna Contacts Media: Colleen Hussey Senior Manager,
Corporate Communications 203-470-5620 Colleen.Hussey@modernatx.com
Dan Budwick 1AB 973-271-6085 Dan@1abmedia.com Investors:
Lavina Talukdar Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
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