Antibody against Chikungunya virus (mRNA-1944)
is the first development candidate from Moderna’s systemic
therapeutics modalities to start human dosing
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 dosing of the first subject in a
Phase 1 clinical trial evaluating the safety and tolerability of
escalating doses of mRNA-1944 via intravenous infusion in healthy
adults. This is the first monoclonal antibody encoded by mRNA to be
dosed in a human and the first development candidate from the
Company’s systemic therapeutics modalities to start clinical
testing.
“We believe this trial will give us important information about
how mRNA may be used to make systemically-available complex
therapeutic proteins in a consistent, dose-dependent fashion,” said
Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “Dosing
the first monoclonal antibody encoded by mRNA in humans is a
significant milestone for our team and mRNA platform. We look
forward to learning about the functionality of our mRNA-encoded
antibody in neutralizing the 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. 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.
Preclinical studies of mRNA-1944 showed linear dose-dependence,
meaning increases in the dose of mRNA led to nearly proportionate
increases in antibody production.
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.
About the Study
The randomized, placebo-controlled Phase 1 study is designed to
evaluate the safety and tolerability of up to four ascending dose
levels (0.1, 0.3, 0.6, 1 mg/kg cohorts with 8 subjects per cohort)
of mRNA-1944 in healthy adults, administered via intravenous
infusion. Other objectives are to determine pharmacodynamics in the
form of serum antibody expression and whether the antibodies
produced against the Chikungunya virus are sufficiently active to
neutralize viral infection in vitro. More information about the
study can be found at ClinicalTrials.gov.
About Moderna’s Systemic Therapeutics Modalities
Moderna has 21 mRNA development candidates in its pipeline,
with 12 programs now in clinical development. These investigational
medicines are grouped together into six modalities based on similar
mRNA technologies, delivery technologies and manufacturing
processes. Typically, programs within a modality will also share
similar pharmacology profiles, including the desired dose response,
the expected dosing regimen, the target tissue for protein
expression, safety and tolerability goals as well as their
pharmaceutical properties.
Moderna scientists designed the Company’s systemic secreted
therapeutics modality to achieve a therapeutic effect in one or
more tissues or cell types by increasing levels of desired secreted
proteins outside the cell, either in circulation or in contact with
the extracellular environment. The goal of this modality is to
provide secreted proteins, such as antibodies or enzyme replacement
therapies across a wide range of diseases, such as infectious
diseases and rare genetic diseases. Three development candidates
are currently included in this modality: antibody against
Chikungunya virus (mRNA-1944 in a Phase 1 study); Relaxin (AZD7970
in IND-enabling GLP toxicology studies); and Fabry disease
(mRNA-3630 in IND-enabling GLP toxicology studies).
The systemic intracellular therapeutics modality uses the
same delivery technology and was designed to achieve a therapeutic
effect in one or more tissues or cell types by producing proteins
encoded by mRNA inside the cell, either located in the cytosol or
specific organelles, like the mitochondria. The goal of this
modality is to provide intracellular proteins, such as
intracellular enzymes and organelle-specific proteins, as safe,
tolerable and efficacious therapies. Moderna currently has three
programs in this modality focused on rare genetic diseases that
cannot be addressed using recombinant proteins. These include
methylmalonic academia or MMA (mRNA-3704 with an open IND for a
Phase 1/2 study); Propionic Acidemia or PA (mRNA-3927 in
IND-enabling GLP toxicology studies); and Phenylketonuria or PKU
(mRNA-3283 in IND-enabling GLP toxicology studies).
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 belief that mRNA therapies can make complex
secreted proteins; Moderna’s ability to move further programs into
clinical trials; the expected outcomes of the Phase 1 clinical
trial for antibody against Chikungunya virus (mRNA-1944); and the
expected outcomes of the Moderna’s other clinical trials. 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 for mRNA-1944 will be predictive of future
clinical study results; whether mRNA-1944 could be unsafe or
intolerable during clinical studies; 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 described in Moderna’s Prospectus
filed with the U.S. Securities and Exchange
Commission (SEC) on December 7, 2018 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/20190205005531/en/
Moderna Contacts:Investors:Lorence KimChief
Financial
Officer617-209-5849Lorence.kim@modernatx.comMedia:Jason
GlashowHead, Corporate
Communications617-674-5648Jason.glashow@modernatx.com
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