mRNA-1273 induced robust neutralizing
antibodies and dose dependent increases in T cell responses
mRNA-1273 led to protection against SARS-CoV-2
infection in the lungs and nose of non-human primates
No evidence of vaccine-associated enhanced
disease (VAERD) observed
Conference call to be held on Wednesday, July
29, 2020 at 8:00 a.m. ET
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 a preclinical study evaluating mRNA-1273,
its vaccine candidate against COVID-19, was published in The New
England Journal of Medicine. The study showed a two-dose
vaccination schedule of mRNA-1273 led to a robust immune response
and protection against SARS-CoV-2 infection in the upper and lower
airways in non-human primates, without evidence of
vaccine-associated enhanced respiratory disease (VAERD).
In the study, immunogenicity and protective efficacy were
assessed after a two-dose vaccination schedule of 10 or 100 µg
doses of mRNA-1273 or control given four weeks apart (n=24; 8 per
group). Four weeks after the second vaccination, animals were
challenged with high doses of SARS-CoV-2 through intranasal and
intratracheal routes.
After two vaccinations, the immune response observed in this
non-human primate study was consistent with the recently reported
Phase 1 human study of mRNA-1273, also published in The New England
Journal of Medicine. At the 10 µg dose, the geometric mean titer
(GMT, ID50) measured in a pseudovirus (PsV) neutralization assay
was 103, similar to the GMT for a panel of convalescent sera
reported previously (109), and below the GMT achieved by mRNA-1273
in the Phase 1 human study at the 100 µg dose (231) in the same PsV
assay. At the higher dose in the non-human primates (100 µg)
neutralizing antibody titers increased further, with PsV GMT
reaching 1,862. Vaccination also led to a significant increase in T
cell responses, primarily Th1 CD4 T cells.
Two doses of mRNA-1273 provided protection against lung
inflammation following viral challenge with SARS-CoV-2 in non-human
primates at both the 10 µg and 100 µg dose levels. In addition,
both the 10 µg and 100 µg dose groups demonstrated protection
against viral replication in the lungs, with the 100 µg dose also
protecting against viral replication in the nose of the animals. Of
note, none of the eight animals in the 100 µg group showed
detectable viral replication in the nose compared to six out of
eight in the placebo group on day 2.
“This important preclinical study shows that mRNA-1273 protected
against a high dose SARS-CoV-2 infection in non-human primates and
prevented pulmonary disease in all animals, further supporting the
clinical advancement of mRNA-1273,” said Stephen Hoge, M.D.,
President at Moderna. “We believe this is the first demonstration
of control of viral replication within two days of challenge in
both the nose and lungs in non-human primates by a vaccine against
COVID-19. Given the similarity between the protective immune
response generated by mRNA-1273 in this study and the immune
response seen in humans in the recently published Phase 1 clinical
data for the vaccine, we remain cautiously optimistic that
mRNA-1273 will be able to prevent COVID-19 disease and may also
slow the spread of SARS-CoV-2 by shortening the duration of
shedding.”
The Biomedical Advanced Research and Development Authority
(BARDA), part of the Office of the Assistant Secretary for
Preparedness and Response (ASPR) within the U.S. Department of
Health and Human Services (HHS), partially supported the research
and development of mRNA-1273 with federal funding under Contract
no. 75A50120C00034. A summary of the company’s work to date on
COVID-19 can be found here.
Conference Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00
a.m. ET on Wednesday, July 29, 2020. To access the live conference
call, please dial 866-922-5184 (domestic) or 409-937-8950
(international) and refer to conference ID 6278397. A webcast of
the call will also be available under “Events and Presentations” in
the Investors section of the Moderna website at
investors.modernatx.com. The archived webcast will be available on
Moderna’s website approximately two hours after the conference
call.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a
prefusion stabilized form of the Spike (S) protein, which was
co-developed by Moderna and investigators from NIAID’s Vaccine
Research Center. The first clinical batch, which was funded by the
Coalition for Epidemic Preparedness Innovations, 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. On May 12, the FDA granted mRNA-1273 Fast Track
designation. Moderna recently announced that data from an interim
analysis of the Phase 1 study of mRNA-1273 was published in The New
England Journal of Medicine. On July 8, the Company’s Phase 2 study
of mRNA-1273 completed enrollment. On July 27, the Phase 3 COVE
study of mRNA-1273, being conducted in collaboration with NIH and
BARDA, began.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines
modality to prevent infectious diseases. More than 1,900
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)
- COVID-19 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 eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya
virus, hMPV/PIV3, CMV, Zika and COVID-19). 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 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 & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense, and 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 five years. To learn more, visit
www.modernatx.com.
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 regarding the Company’s development of
a potential vaccine against the novel coronavirus, and the
potential for mRNA-1273 to prevent COVID-19 disease and slow the
spread of SARS-CoV-2. 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 due to the global COVID-19 pandemic such as delays
in regulatory review, manufacturing and clinical trials, 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/20200728005949/en/
Media: Colleen Hussey Senior Manager, Corporate Communications
203-470-5620 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
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