Award will fund development of mRNA-1273 to FDA
licensure
Award will fund manufacturing process scale-up
to enable large-scale production in 2020 for pandemic response
NIH-led Phase 1 study of mRNA-1273 has
completed enrollment of 3 dose cohorts (25 µg, 100 µg and 250 µg);
expanding to an additional 6 cohorts of older adults and elderly
adults
Phase 2 study expected to begin in Q2 2020,
following safety data from ongoing Phase 1 study
Moderna to hire up to 150 new team members to
support efforts
Conference call to be held on Friday, April 17
at 8:00 a.m. ET
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 an agreement for a commitment of up to
$483 million 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), to accelerate
development of the Company’s mRNA vaccine candidate (mRNA-1273)
against the novel coronavirus (SARS-CoV-2).
Under the terms of the agreement, BARDA will fund the
advancement of mRNA-1273 to FDA licensure. A Phase 1 study of
mRNA-1273 is being conducted by the National Institutes of Health
(NIH). The Phase 1 open-label study, which began on March 16, 2020
has completed enrollment of the original study: 45 healthy adult
volunteers ages 18 to 55 years in three dose cohorts (25 µg, 100 µg
and 250 µg). The NIH recently amended the Phase 1 protocol to
include an additional six cohorts: three cohorts of older adults
(ages 51-70) and three cohorts of elderly adults (age 71 and
above). Enrollment for these cohorts is ongoing.
If supported by safety data from the Phase 1 study, the Company
intends to begin a Phase 2 study of mRNA-1273 under its own
Investigational New Drug (IND) application in the second quarter of
2020. Subject to data from these studies and discussions with
regulators, a Phase 3 study could begin as soon as fall, 2020.
BARDA funding will support these late-stage clinical development
programs, as well as the scale-up of mRNA-1273 manufacture in 2020
to enable potential pandemic response.
To support the scale-up, Moderna plans to hire up to 150 new
team members in the U.S. this year. This includes a significant
increase in its skilled manufacturing staff to expand manufacturing
capacity from two shifts per day, 5 days per week to three shifts
per day, 7 days per week, engineers to manage process scale-up, and
clinical and regulatory staff to support clinical development.
“We are thankful for BARDA’s support to fund the accelerated
development of mRNA-1273, our vaccine candidate against
SARS-CoV-2,” said Stéphane Bancel, Moderna’s Chief Executive
Officer. “Time is of the essence to provide a vaccine against this
pandemic virus. By investing now in our manufacturing process
scale-up to enable large scale production for pandemic response, we
believe that we would be able to supply millions of doses per month
in 2020 and with further investments, tens of millions per month in
2021, if the vaccine candidate is successful in the clinic.”
“Vaccines are a critical tool for saving lives and stopping the
spread of the SARS-CoV-2 virus,” said BARDA Director Rick Bright,
Ph.D. “Delivering a safe and effective vaccine for a rapidly
spreading virus requires accelerated action. BARDA’s goal is to
have vaccine available as quickly as possible and preparing now for
advanced stage clinical trials and production scale-up while the
Phase 1 is underway could shave months off development of COVID-19
vaccines.”
Conference Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00
a.m. ET on Friday, April 17, 2020. To access the live conference
call, please dial 866-922-5184 (domestic) or 409-937-8950
(international) and refer to conference ID 5115809. 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 mRNA-1273
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 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
NIH-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days
from sequence selection to Phase 1 study dosing. A summary of the
Company’s work to date on SARS-CoV-2 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 1,400
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 six 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)
- Novel coronavirus (SARS-CoV-2) 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 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 Statement
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, BARDA funding
for the development and manufacture of mRNA-1273 and the
sufficiency of such funding, the intention to file an IND related
to mRNA-1273, the expected conduct and timing of Phase 2 and Phase
3 clinical trials of mRNA-1273, potential future supply of
mRNA-1273, and future hiring plans. 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 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200416005985/en/
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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