Collaboration includes the National Institutes
of Health (NIH) and leverages flexibility of Moderna’s mRNA vaccine
technology
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, and the Coalition for Epidemic Preparedness Innovations
(CEPI), today announced a new collaboration to develop an mRNA
vaccine against the novel coronavirus (2019-nCoV).
Under the terms of the agreement, Moderna will manufacture an
mRNA vaccine against 2019-nCoV, which will be funded by CEPI. The
Vaccine Research Center (VRC) of the National Institute of Allergy
and Infectious Diseases (NIAID), part of NIH, collaborated with
Moderna to design the vaccine. NIAID will conduct IND-enabling
studies and a Phase 1 clinical study in the U.S.
Over the past four years Moderna has had six positive Phase 1
clinical readouts in its prophylactic vaccines modality and moved
two additional programs into development. Moderna’s technology
platform, fully integrated manufacturing site and development
experience, combined with a multi-year relationship with the NIH,
including exploring ways to respond to public health threats,
allows for the rapid identification and advancement of a vaccine
candidate against 2019-nCoV.
“Moderna’s commitment to global public health is aligned with
CEPI’s vision of creating a world in which epidemics are no longer
a threat to humanity,” said Richard Hatchett, M.D., CEO of CEPI.
“We are pleased with the pace of our combined response to the
emerging threat of the novel coronavirus. Through our partnership
with Moderna and the NIH, we hope to speed the development of a
vaccine against the coronavirus and help to alleviate the burden of
disease.”
“We believe our mRNA vaccine technology offers potential
advantages in the speed of development and production scalability,
which positions Moderna to potentially develop a vaccine against
coronavirus, 2019-nCoV,” said Stéphane Bancel, CEO of Moderna.
“Advances in global public health require the collective effort of
public-private partnerships – no organization can act alone. We are
honored to be supporting NIH and CEPI in their mission to identify
a potential vaccine to prevent infection. It is impressive that
CEPI was able to commit to this grant in a matter of days. We are
thankful for the financial support from CEPI and the multi-year
scientific collaboration we have with the NIH.”
About Coronavirus
Coronaviruses are a family of viruses that can lead to
respiratory illness, including Middle East Respiratory Syndrome
(MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
Coronaviruses are transmitted between animals and people and can
evolve into strains not previously identified in humans. On January
7, 2020, a novel coronavirus (2019-nCoV) was identified as the
cause of pneumonia cases in Wuhan City, Hubei Province of China,
and additional cases have been found in a growing number of
countries.1,2
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the Company’s prophylactic vaccines
modality to prevent or control infectious diseases. This modality
now includes five programs, all of which are vaccines against
viruses. More than 1,000 participants have been enrolled in
Moderna’s infectious disease vaccine clinical studies under health
authorities in the U.S., Europe and Australia.
The potential advantages of an mRNA approach to prophylactic
vaccines include the ability to mimic natural infection to
stimulate a more potent immune response, combining 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 currently has five development candidates for potential
commercial uses in this modality, including: respiratory syncytial
virus (RSV) vaccine (mRNA-1777 and mRNA-1172 or V172 with Merck),
cytomegalovirus (CMV) vaccine (mRNA-1647), human metapneumovirus
and parainfluenza virus type 3 (hMPV/PIV3) vaccine (mRNA-1653) and
Zika vaccine (mRNA-1893) with the Biomedical Advanced Research and
Development Authority (BARDA). Three development candidates in this
modality are available for potential global health uses including:
influenza H10N8 vaccine (mRNA-1440), influenza H7N9 vaccine
(mRNA-1851) and chikungunya vaccine (mRNA-1388), which was
developed with the Defense Advanced Research Projects Agency
(DARPA).
To date, Moderna has demonstrated positive Phase 1 data readouts
for six prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus,
hMPV/PIV3 and CMV). Moderna’s CMV vaccine is currently in a Phase 2
dose-selection study. Moderna’s investigational Zika vaccine
(mRNA-1893), currently in a Phase 1 study, was granted FDA Fast
Track designation.
Moderna has built a fully integrated, highly digitalized
manufacturing plant in Norwood, MA which enables the promise of the
technology platform.
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 have a therapeutic or preventive
benefit with the potential to address a broad spectrum of diseases.
Moderna’s platform builds on continuous advances in basic and
applied mRNA science, delivery technology and manufacturing,
providing the Company 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.
(NASDAQ: AZN) and Merck, Inc. (NASDAQ: MRK), as well as the Defense
Advanced Research Projects Agency (NASDAQ: 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.
Special Note Regarding 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, the Company’s intention to develop a
potential vaccine for novel Coronavirus; the intent to obtain
funding from CEPI for such development; and the time expected for
such development In some cases, forward-looking statements can be
identified by terminology such as “will,” “may,” “should,”
“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 execution of final definitive agreements between
the Company and CEPI; 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 being
developed and implemented; the fact that funding for such project
has not yet been received by the Company and those 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.
1 “Coronavirus.” World Health Organization,
https://www.who.int/health-topics/coronavirus. 2 “2019 Novel
Coronavirus, Wuhan, China.” Centers for Disease Control and
Prevention,
https://www.cdc.gov/coronavirus/2019-nCoV/index.html.
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version on businesswire.com: https://www.businesswire.com/news/home/20200123005458/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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