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 U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for its
investigational Zika vaccine (mRNA-1893) currently being evaluated
in a Phase 1 study for the prevention of Zika virus infection in
healthy adults.
Fast Track is designed to facilitate the development and
expedite the review of therapies and vaccines for serious
conditions and fill an unmet medical need. Programs with Fast Track
designation may benefit from early and frequent communication with
the FDA, in addition to a rolling submission of the marketing
application. Moderna previously received Fast Track designation for
its methylmalonic acidemia (MMA) program (mRNA-3704), which is now
recruiting patients for a Phase 1/2 clinical study.
“Protecting against Zika virus transmission, particularly in
women during pregnancy, continues to be an area of high unmet need.
Fast Track designation supports our belief in the clinical
potential of mRNA-1893 and the importance of developing an
effective vaccine that can be rapidly developed and deployed,” said
Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “Our Zika
program is part of Moderna’s broader commitment to improving global
public health through developing mRNA vaccines to prevent the
spread of infectious diseases.”
mRNA-1893 contains an mRNA sequence encoding for the structural
proteins of Zika virus and is designed to cause cells to secrete
virus-like particles, mimicking the response of the cell after
natural infection. Preclinical data published in The Journal of
Infectious Diseases have shown that vaccination with mRNA-1893
protected against transmission of Zika virus during pregnancy in
mice.1 mRNA-1893 is currently in a Phase 1 study evaluating safety,
pharmacokinetics and pharmacodynamics in healthy volunteers.
This project has been funded in whole or in part with Federal
funds from the Department of Health and Human Services (HHS);
Office of the Assistant Secretary for Preparedness and Response;
Biomedical Advanced Research and Development Authority (BARDA),
under Contract No. HHSO100201600029C.
About the Phase 1 Study
This randomized, observer-blind, placebo-controlled,
dose-ranging study is designed to evaluate the safety, tolerability
and immunogenicity of mRNA-1893 in healthy flavivirus seropositive
and seronegative adults ages 18 to 49 years. Primary outcome
measures include frequency and grade of adverse events. Secondary
outcome measures include geometric mean titers of neutralizing
antibodies against Zika virus.
About Zika
Zika virus has rapidly emerged in recent years as a pandemic
with potential long-term public health implications. Zika is
primarily transmitted by mosquitos, but can also be transmitted
sexually. Children born to mothers infected with Zika can develop
microcephaly, a severe disease characterized by small, not fully
developed heads and severe disabilities. In adults, outbreaks in
Latin American and Caribbean countries have been associated with
Guillain-Barre syndrome, a rare but serious autoimmune disorder in
which the immune system attacks part of the nervous system.2 There
is no approved vaccine for Zika.
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. 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 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). 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.
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, but not limited to, statements
concerning: the potential of mRNA therapeutics and vaccines as a
new generation of transformative medicines for patients, the
potential of Fast Track Designation to accelerate development and
approval of mRNA-1893, Moderna’s belief in the clinical potential
of mRNA-1893 and its potential to be rapidly developed and
deployed, Moderna’s ability to improve global public health through
developing mRNA vaccines to prevent the spread of infectious
diseases. In some cases, forward-looking statements can be
identified by terminology such as “will,” “may,” “should,”
“expects,” “intends,” “plans,” “design,” “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: Fast Track Designation by the FDA
for mRNA-1893 may not lead to a faster development process, review,
or approval compared to conventional FDA procedures, and it does
not increase the likelihood that mRNA-1893 will receive marketing
approval; the FDA may withdraw Fast Track Designation if it
believes that the designation is no longer supported by data from
mRNA-1893’s clinical development program; Fast Track Designation
alone does not guarantee qualification for the FDA’s priority
review procedures; preclinical and clinical development is lengthy
and uncertain, especially for a new class of medicines such as
mRNA, and therefore our preclinical programs or development
candidates may be delayed, terminated, or may never advance to or
in the clinic; no mRNA drug has been approved in this new potential
class of medicines, and may never be approved; mRNA drug
development has substantial clinical development and regulatory
risks due to the novel and unprecedented nature of this new class
of medicines; 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 Jagger et al. Protective efficacy of nucleic acid vaccines
against transmission of Zika virus during pregnancy in mice. The
Journal of Infectious Diseases. 2019; jiz338,
https://doi.org/10.1093/infdis/jiz338.
2 Krauer et al. Zika virus infection as a cause of congenital
brain abnormalities and Guillain-Barré syndrome: Systematic review.
PLoS Med. 2017; 14(1):e1002203.
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Moderna Contacts: Investors: Lavina Talukdar Head of Investor
Relations 617-209-5834 Lavina.Talukdar@modernatx.com
Media: Colleen Hussey Senior Manager, Corporate
Communications 203-470-5620 Colleen.Hussey@modernatx.com
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