Phase 2 study expected to enroll 600
participants
Finalizing protocol for Phase 3 study, expected
to begin in July 2020
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 participants in each age
cohort have been dosed in the Company’s Phase 2 study of its mRNA
vaccine candidate (mRNA-1273) against the novel coronavirus
(SARS-CoV-2).
This Phase 2 study, being conducted by Moderna under its own
Investigational New Drug (IND) application, will evaluate the
safety, reactogenicity and immunogenicity of two vaccinations of
mRNA-1273 given 28 days apart. The Company intends to enroll 600
healthy participants across two cohorts of adults ages 18-55 years
(n=300) and older adults ages 55 years and above (n=300). Each
participant will be assigned to receive placebo, a 50 μg or a 100
μg dose at both vaccinations. Participants will be followed through
12 months after the second vaccination. Given the 25 μg and 100 μg
dose levels in the Phase 1 study showed neutralizing antibody
titers at or above convalescent sera and were generally well
tolerated, the Company has decided not to pursue the 250 μg dose
level in the Phase 2 study.
On May 6, the U.S. Food and Drug Administration (FDA) completed
its review of the Company’s Investigational New Drug (IND)
application for mRNA-1273 and on May 12, the FDA granted it Fast
Track designation. On May 18, Moderna announced initial data from
the Phase 1 study of mRNA-1273 led by the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH). The NIH will be submitting the Phase 1
data to a peer-reviewed clinical publication. Moderna anticipates
collaborating with NIAID to implement the Phase 3 study. The dose
for the Phase 3 study is expected to be between 25 µg and 100 µg
and expects Phase 3 trial initiation in July, subject to
finalization of the clinical trial protocol.
Funding 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), supported the
planning for these studies and will also support the late-stage
clinical development programs, as well as the scale-up of mRNA-1273
manufacturing both at the Company’s facilities and that of its
strategic collaborator, Lonza Ltd. A summary of the company’s work
to date on SARS-CoV-2 can be found here.
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 NIAID, a part of the NIH. The
first clinical batch, which was funded by CEPI, 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.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines
modality to prevent infectious diseases. More than 1,500
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)
- 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, 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
and Merck & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense, and BARDA. Moderna has been named a top biopharmaceutical
employer by Science 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, the potential
benefits of mRNA based vaccines, the benefits of Fast Track
designation, the parameters and timing of the planned Phase 2 study
of mRNA-1273, the parameters of, timing of and planned dosing in
the planned Phase 3 study of mRNA-1273, and BARDA funding for
clinical studies and manufacturing activities. 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 on the
Company’s programs 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
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/20200529005628/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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