Published in Science Immunology, study shows
mRNA encoding antibody against chikungunya virus is well tolerated,
results in linear dose-dependent protein expression and provides
100 percent protection against infection in animals
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 the publication of preclinical data
in Science Immunology, showing that mRNA encoding a human
monoclonal antibody against the chikungunya virus delivered in a
proprietary lipid nanoparticle (LNP) can protect from infection by
the virus in vivo. These data supported the initiation of a Phase 1
program of mRNA-1944 against chikungunya virus in January 2019 to
evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of escalating doses of mRNA-1944 via intravenous
infusion in healthy adults.
“These preclinical data demonstrate three critical features of
our therapeutic platform: first, that it was well-tolerated, with
no dose-limiting toxicities; second, we showed linear
dose-dependent pharmacology; and third, that the expressed protein
was able to prevent disease,” said Stephen Hoge, M.D., president at
Moderna. “The mRNA and delivery technologies presented here
underpin our expansion into systemic therapeutics in humans, first
with mRNA-1944 against chikungunya virus this past January, and
soon with our first metabolic rare disease program, mRNA-3704, for
methylmalonic acidemia.”
The preclinical data published today showed that treatment with
mRNA was well tolerated at doses ranging from 0.3 mg/kg to 3.0
mg/kg in non-human primates, with linear dose-dependent
pharmacology, meaning that increases in mRNA doses result in
predictable and proportionate increases in expressed antibody in
the blood. Finally, in a mouse viral challenge model for
chikungunya virus infection, the mRNA-encoded protein provided
protection from arthritis, musculoskeletal tissue infection and
death. Extrapolating these findings from the preclinical models
suggests that persistence of antibody levels of at least 1
microgram per milliliter could be protective against chikungunya
virus infection in humans.
“Using the body’s own machinery to produce antibodies against
chikungunya by using mRNA may be a powerful way to combat the
virus,” said James Crowe Jr., MD, director of the Vanderbilt
Vaccine Center. “We are pleased that our early work contributed to
these preclinical findings and look forward to the results from the
ongoing Phase 1 clinical study of the antibody against chikungunya
virus.”
mRNA-1944 encodes a fully human IgG antibody originally isolated
from B cells of a patient with a prior history of potent immunity
against chikungunya infection, a mosquito-borne virus. It is
composed of two mRNAs that encode the heavy and light chains of
this anti-chikungunya antibody within Moderna’s proprietary lipid
nanoparticle (LNP) technology. The research and development of
mRNA-1944 was financially supported by the Defense Advanced
Research Projects Agency (DARPA), an agency of the U.S.
Department of Defense, and the antibody was initially identified by
researchers at Vanderbilt University Medical Center.
A link to the publication, A Lipid-encapsulated mRNA Encoding a
Potently Neutralizing Human Monoclonal Antibody Protects Against
Chikungunya Infection (Kose, et al.), can be found here.
Moderna currently has 21 mRNA development candidates in its
portfolio spanning infectious diseases, immuno-oncology, rare
diseases and cardiovascular disease, with 11 of these development
candidates now in the clinic. The Company’s pipeline can be found
at www.modernatx.com/pipeline. In the past three years, Moderna and
collaborators have published more than 26 peer-reviewed papers,
with 13 in the last year alone.
About Chikungunya
Chikungunya is a mosquito-borne virus that poses a significant
public health problem in tropical and subtropical regions. The
disease is characterized by an acute onset of fever, rash, muscle
pain, and sometimes debilitating pain in multiple joints. There are
currently no effective therapies or approved vaccines to treat or
prevent chikungunya infection or disease, and effective mosquito
control is challenging. Currently, people infected with chikungunya
are treated with non-steroidal anti-inflammatory drugs to relieve
some symptoms. In addition to a systemic secreted antibody that
could provide passive immunity, Moderna is also exploring using
mRNA to encode viral antigens as a prophylactic vaccine against the
chikungunya virus (mRNA-1388).
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 suggestion that preclinical data for mRNA-1944
showing passive immunization may lead to the prevention of
infectious diseases like chikungunya in humans and that mRNA-1944
may be well-tolerated and delivered in a dose-dependent manner in
humans; and the potential for the human body to use its own
machinery to produce antibodies against Chikungunya by using mRNA
to combat the virus. 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: whether preclinical results of mRNA-1944 will be
predictive of any future clinical studies, including the ongoing
Phase 1 clinical study of mRNA-1944; whether mRNA-1944 will be
shown to be unsafe or intolerable during future preclinical or
clinical studies; clinical development is lengthy and uncertain,
especially for a new class of medicines such as mRNA, and therefore
our clinical programs or development candidates may be delayed,
terminated, or may never advance; 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190517005476/en/
Moderna Contacts:
Investors:Lavina TalukdarHead of Investor
Relations617-209-5834lavina.talukdar@modernatx.com
Media:Jason GlashowHead of Corporate
Communications617-674-5648Jason.glashow@modernatx.com
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