Cohorts of younger adults (n=300) and older
adults (n=300) in Phase 2 study fully enrolled
Cohorts of older adults (ages 56-70, n=30) and
elderly adults (ages 71 and above, n=30) in NIH-led Phase 1 study
completed enrollment; results expected to be published once
available
Pivotal Phase 3 study expected to begin in
July; manufacture of vaccine required to start Phase 3 study
completed
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 it has completed enrollment for both
cohorts of the Phase 2 study of its vaccine candidate (mRNA-1273)
against COVID-19. mRNA-1273 is Moderna’s second mRNA vaccine for an
infectious disease to complete enrollment of a Phase 2 study,
following the Company’s CMV Phase 2 study, which was fully enrolled
on March 3, 2020.
On June 11, 13 days after the first participant was dosed, the
Company announced that the cohort of healthy younger adults ages
18-55 (n=300) and the sentinel group of older adults ages 55 years
and above (n=50) in the Phase 2 study of mRNA-1273 was complete.
After reviewing the safety data from the sentinel cohort of older
adults, on June 25, the Data and Safety Monitoring Committee of the
study recommended Moderna to proceed with enrollment for the
remainder of the Phase 2 study. The cohort of older adults (n=300)
has now been fully enrolled. This Phase 2 placebo-controlled,
dose-confirmation study is evaluating the safety, reactogenicity
and immunogenicity of two vaccinations of mRNA-1273 given 28 days
apart. Each participant is receiving placebo, a 50 μg or a 100 μg
dose at both vaccinations.
The Company also announced that the cohorts of older adults
(ages 56-70, n=30) and elderly adults (ages 71 and above, n=30) in
NIH-led Phase 1 study have completed enrollment. Results are
expected to be published once available.
“I would like to thank the healthy volunteer participants, our
partners at clinical trial sites and the dedicated Moderna team for
their support in completing enrollment of the Phase 2 study of
mRNA-1273, our vaccine candidate against COVID-19,” said Tal Zaks,
M.D., Ph.D., Chief Medical Officer at Moderna. “We are committed to
helping address this ongoing public health emergency and continue
to focus on our Phase 3 study, which remains on track to start in
July, less than seven months from the sequencing of the virus.”
Moderna has finalized the Phase 3 study protocol based on
feedback from the U.S. Food and Drug Administration (FDA). 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. and is expected to be conducted in collaboration with NIAID,
subject to regulatory approval. Moderna has completed manufacture
of vaccine required to start the Phase 3 study. With the Phase 3
dose at 100 μg, 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.
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.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines
modality to prevent infectious diseases. More than 1,600
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 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 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 2 and planned Phase 3 studies of mRNA-1273,
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/20200708005579/en/
Media: Colleen Hussey Senior Manager, Corporate Communications
203-470-5620 Colleen.Hussey@modernatx.com Investors: Lavina
Talukdar Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
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