Additional funding to support expanded
mRNA-1273 clinical development plan including 30,000 participant
Phase 3 COVE study conducted in collaboration with the NIH
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 a modification to its contract with the
Biomedical Advanced Research and Development Authority (BARDA) for
an additional commitment of up to $472 million to support late
stage clinical development including the expanded Phase 3 study of
the Company’s mRNA vaccine candidate (mRNA-1273) against
COVID-19.
An earlier award from BARDA for up to $483 million was entered
into to support the scale up of mRNA-1273 and clinical development,
originally with a smaller anticipated number of participants in the
Phase 3 clinical trial. Following discussions with the U.S. Food
and Drug Administration (FDA) and consultations with Operation Warp
Speed over the past several months, the Company has decided to
conduct a significantly larger Phase 3 clinical trial, leaving a
gap in BARDA funding that will be closed by this contract
modification. Under the terms of the revised contract, BARDA is
expanding their support of the Company’s late stage clinical
development of mRNA-1273, including the execution of a 30,000
participant Phase 3 study in the U.S. The total value of the award
is now approximately $955 million.
“We thank BARDA for this continued commitment to mRNA-1273, our
vaccine candidate against COVID-19.” said Stéphane Bancel,
Moderna’s Chief Executive Officer. “Encouraged by the Phase 1 data,
we believe that our mRNA vaccine may aid in addressing the COVID-19
pandemic and preventing future outbreaks.”
The Phase 3 COVE study is being conducted in collaboration with
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH) and is expected to begin
tomorrow, July 27. The Phase 3 study protocol has been reviewed by
the U.S. Food and Drug Administration (FDA) and is aligned to
recent FDA guidance on clinical trial design for COVID-19 vaccine
studies. The randomized, 1:1 placebo-controlled trial is expected
to include approximately 30,000 participants at the 100 µg dose
level in the U.S. 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. The
ClinicalTrials.gov identifier is NCT04470427.
Moderna is working closely with Operation Warp Speed and the
NIH, including NIAID’s COVID-19 Prevention Trials Network (CoVPN),
to conduct the Phase 3 COVE study. Working together with
collaborators like NIH, 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 from the Company’s internal U.S.
manufacturing site and strategic collaboration with Lonza. In
addition, Moderna recently announced a collaboration with Catalent
for large-scale, commercial fill-finish manufacturing of mRNA-1273
at Catalent’s biologics facility in Indiana. Initial funding of
$1.3 billion for Moderna to begin producing mRNA-1273 supply
at-risk was secured from investors in the Company’s most recent
public equity offering in May 2020.
BARDA is part of the Office of the Assistant Secretary for
Preparedness and Response within the U.S. Department of Health and
Human Services. This project has been funded in whole or in part
with Federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development Authority,
under Contract No. 75A50120C00034.
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 the
VRC. 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. A summary of the company’s work to
date on COVID-19 can be found here.
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 (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 Phase 3 study of mRNA-1273, the Company’s belief
that mRNA-1273 may aid in addressing the COVID-19 pandemic and
preventing future outbreaks, and the Company’s potential
manufacturing capabilities and projected vaccine dose production.
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/20200726005025/en/
Moderna 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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