Moderna Announces Publication of Preclinical Data for Chikungunya Antibody Program
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
“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
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
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 (
A link to the publication, A Lipid-encapsulated mRNA Encoding a
Potently Neutralizing Human Monoclonal Antibody Protects Against
Chikungunya Infection (
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,
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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
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Source:
Moderna Contacts:
Investors:
Lavina Talukdar
Head of Investor Relations
617-209-5834
lavina.talukdar@modernatx.com
Media:
Jason Glashow
Head of Corporate Communications
617-674-5648
Jason.glashow@modernatx.com