63 days from sequence selection to Phase 1
study dosing
mRNA-1273 is Moderna’s 10th infectious disease
vaccine to begin a clinical trial
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 first participant has been dosed
in the Phase 1 study of the Company’s mRNA vaccine (mRNA-1273)
against the novel coronavirus (SARS-CoV-2). This Phase 1 study is
being conducted by the National Institutes of Health (NIH) under
its own Investigational New Drug (IND) application.
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 the
Vaccine Research Center (VRC) at the National Institute of Allergy
and Infectious Diseases (NIAID), a part of NIH. Manufacture of the
first clinical batch was funded by the Coalition for Epidemic
Preparedness Innovations (CEPI).
The Phase 1 study is evaluating the safety and immunogenicity of
three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a
two-dose vaccination schedule, given 28 days apart. A total of 45
healthy adults will be enrolled in the study. Participants will be
followed through 12 months after the second vaccination. The
primary objective is to evaluate the safety and reactogenicity of a
two-dose vaccination schedule of mRNA-1273. The secondary objective
is to evaluate the immunogenicity to the SARS-CoV-2 S protein.
“This study is the first step in the clinical development of an
mRNA vaccine against SARS-CoV-2, and we expect it to provide
important information about safety and immunogenicity. We are
actively preparing for a potential Phase 2 study under our own
IND,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna.
“We are grateful to NIH for their ongoing collaboration and to CEPI
for funding the initial manufacturing of mRNA-1273 and are proud to
be included with the many companies, worldwide health agencies and
NGOs working on a possible response to the novel coronavirus
outbreak.”
On January 11, 2020, the Chinese authorities shared the genetic
sequence of the novel coronavirus. On January 13, 2020 the VRC and
Moderna’s infectious disease research team finalized the sequence
for the SARS-CoV-2 vaccine and Moderna mobilized toward clinical
manufacture. The first clinical batch was completed on February 7,
2020 and underwent analytical testing; it was shipped on February
24, 2020 from Moderna and delivered to NIH from the Company’s
manufacturing facility in 42 days from sequence selection.
Next Steps for mRNA-1273
The Company is actively preparing for a potential Phase 2 study
under its own IND to build on data from the ongoing Phase 1 study
being conducted by the NIH. In order to continue to progress this
potential vaccine during the ongoing global public health
emergency, Moderna intends to work with the FDA and other
government and non-government organizations to be ready for a Phase
2 and any subsequent trials, which are anticipated to include a
larger number of subjects and which will seek to generate
additional safety and immunogenicity data. Manufacture of the
mRNA-1273 material for the potential Phase 2 trial, which could
begin in a few months, is underway. Moderna continues to prepare
for rapid acceleration of its manufacturing capabilities that could
allow for the future manufacture of millions of doses should
mRNA-1273 prove to be safe and effective.
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 can be transmitted between animals and people and
evolve into strains not previously identified in humans. On January
7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the
cause of pneumonia cases in Wuhan, Hubei Province of China, and
additional cases have been found in a growing number of
countries.1,2
About Moderna’s Prophylactic Vaccines Core 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. Based on clinical experience across six Phase
1 studies, the Company has designated prophylactic vaccines a core
modality and intends to accelerate development of its infectious
disease vaccine candidates.
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 has
built a fully integrated manufacturing plant in Norwood, MA 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 and parainfluenza virus type 3
(hMPV/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 the Biomedical Advanced Research
and Development Authority (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 six prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus,
hMPV/PIV3 and CMV). 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.
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, Inc., as well as the Defense Advanced Research Projects
Agency (DARPA), an agency of the U.S. Department of Defense, 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) and the Coalition for Epidemic Preparedness
Innovations (CEPI). Moderna has been ranked in the top ten of
Science’s list of top biopharma industry employers for the past
four 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, the conduct and
timing of the Phase I trial of mRNA-1273, the planning, conduct and
timing of a potential Phase 2 and any subsequent trials of
mRNA-1273, and potential manufacturing capabilities. 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 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; 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.
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/20200316005666/en/
Media: Colleen Hussey Senior Manager, Corporate
Communications 203-470-5620 Colleen.Hussey@modernatx.com
Katie Engleman 1AB Katie@1abmedia.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
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