Phase 3 study being conducted in collaboration
with NIH and BARDA
Expected to enroll 30,000 participants in the
U.S.
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 that the Phase 3 study of its mRNA
vaccine candidate (mRNA-1273) against COVID-19 has begun dosing
participants. The Phase 3 study, called the COVE (Coronavirus
Efficacy) study, is being conducted in collaboration with the
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH) and the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response at
the U.S. Department of Health and Human Services.
“We are pleased to have started the Phase 3 COVE study,” said
Stephane Bancel, CEO at Moderna. “We are grateful to the efforts of
so many inside and outside the company to get us to this important
milestone. We are indebted to the participants and investigators
who now begin the work of the COVE study itself. We look forward to
this trial demonstrating the potential of our vaccine to prevent
COVID-19, so that we can defeat this pandemic.”
The Phase 3 study protocol follows the U.S. Food and Drug
Administration (FDA) guidance on clinical trial design for COVID-19
vaccine studies. The randomized, placebo-controlled trial is
expected to include approximately 30,000 participants in the United
States, testing an mRNA-1273 dosage of 100 µg. The 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 regardless of symptomology. SARS-CoV-2 is
the virus that causes COVID-19.
The primary efficacy analysis of the Phase 3 study will be an
event-driven analysis based on the number of participants with
symptomatic COVID-19 disease. To ensure the ongoing safety
monitoring of the participants in the trial, data will be reviewed
by an independent Data and Safety Monitoring Board organized by
NIAID throughout the study. The clinicaltrials.gov identifier is
NCT04470427.
Moderna is working closely with BARDA and the NIH, including
NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3
COVE study under the auspices of Operation Warp Speed.
Moderna also is collaborating with long-standing partner PPD
(Nasdaq: PPD), a leading global contract research organization
providing comprehensive, integrated drug development, laboratory
and lifecycle management services. PPD supported the Phase 2 study
for Moderna’s COVID-19 vaccine program, which completed the
enrollment of 600 subjects at eight research sites within a month.
PPD has contributed an array of clinical development and laboratory
services, including strategic expertise to the study design,
patient-enrollment epidemiology modeling and biostatistics.
With its collaborators, Moderna has selected nearly 100 clinical
research sites with representative demography and is partnering
closely with those sites to ensure that volunteers at increased
risk for COVID-19 disease are enrolled in the study. The clinical
research sites, with the support of the Company, are working within
their local communities to reach a diverse population. Working
together with collaborators, the Company hopes to achieve a shared
goal that the participants in the COVE study are representative of
the communities at highest risk for COVID-19 and of our diverse
society.
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 because of the Company’s internal U.S.
manufacturing capabilities and strategic collaboration with Lonza,
Ltd. In addition, Moderna recently announced a collaboration with
Catalent, Inc. for large-scale, commercial fill-finish
manufacturing of mRNA-1273 at Catalent’s biologics facility for the
U.S., and with ROVI of Spain for fill-finish manufacturing outside
the U.S.
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
co-developed by Moderna and investigators from NIAID’s Vaccine
Research Center. 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. On May 12, the FDA granted mRNA-1273 Fast Track
designation. Both cohorts, healthy adults ages 18-55 years (n=300)
and older adults ages 55 years and above (n=300), in the Company’s
Phase 2 study of mRNA-1273 are fully enrolled. Moderna also
recently announced that data from an interim analysis of the Phase
1 study of mRNA-1273 was published in The New England Journal of
Medicine.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines
modality to prevent infectious diseases. More than 1,900
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 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
ranked in the top ten of Science’s list of top biopharma industry
employers 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 planned Phase 3 study of mRNA-1273, the Company’s
potential manufacturing capabilities and projected vaccine dose
production, and the demographics of the participants in the Phase 3
study. 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/20200727005336/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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