mRNA-1273 induced consistently high levels of
pseudovirus neutralization antibody titers in all participants in
the 56-70 (n=10) and 71+ (n=10) age cohorts
Potent neturalization responses were confirmed
by 3 different live virus assays
mRNA-1273 elicited Th1-biased CD4 T cell
responses in the 56-70 and 71+ age cohorts
Neutralizing antibody titers and T cell
responses in the 56-70 and 71+ age cohorts were consistent with
those reported in younger adults
At the 25 µg and 100 µg dose levels, mRNA-1273
was generally well-tolerated in all age cohorts
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines to create a new
generation of transformative medicines for patients, today
announced the publication of the second interim analysis of the
open-label Phase 1 study of mRNA-1273, its vaccine candidate
against COVID-19, in The New England Journal of Medicine. This
interim analysis evaluated a two-dose vaccination schedule of
mRNA-1273 given 28 days apart in 40 healthy adult participants
across two dose levels (25 and 100 µg) in two age cohorts (ages
56-70 and ages 71+), and reports results through Day 57 (1 month
after the second dose). This analysis found that both the 25 µg and
100 µg dose levels were generally well-tolerated in both age
cohorts. Immune responses were dose-dependent with the 100 µg dose
eliciting higher binding and neutralizing antibody titers,
supporting the selection of the 100 µg dose for further study in
the Phase 3 trial. The study was led by the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH).
“These interim Phase 1 data suggests that mRNA-1273, our vaccine
candidate for the prevention of COVID-19, can generate neutralizing
antibodies in older and elderly adults at levels comparable to
those in younger adults,” said Tal Zaks, M.D., Ph.D., Chief Medical
Officer of Moderna. “Given the increased morbidity and mortality of
COVID-19 in older and elderly adults, these data give us optimism
in demonstrating mRNA-1273’s protection in this population, which
is being evaluated in the Phase 3 COVE study.”
Both the 25 µg and 100 µg dose levels of mRNA-1273 were
generally well-tolerated, with no serious adverse events reported
through Day 57. The most common solicited adverse events were
headache, fatigue, myalgia, chills, and pain at the injection site,
the majority of which were mild-to-moderate in severity and of
self-limited duration. Local and systemic reactogenicity were more
common and more frequently moderate in severity after the second
dose. Two severe solicited systemic adverse events occurred
following the second vaccination: fever in one participant in the
ages 56-70 cohort who received the 25 µg dose and fatigue in one
participant in the ages 71+ cohort who received the 100 µg dose.
Clinical laboratory values of Grade 2 or higher revealed no pattern
of concern. Participants will continue to be followed through
13-months to allow for a longer assessment of vaccine-related
adverse events.
At both the 25 µg and 100 µg dose levels, after two
vaccinations, mRNA-1273 induced dose-dependent binding antibody
responses reaching the upper quartile of the distribution of
convalescent sera. At Day 57 (1 month post-dose 2), geometric mean
titers (GMT) exceeded the median of those seen in convalescent sera
from 41 individuals with confirmed COVID-19 diagnosis.
Neutralizing activity was assessed with multiple assays,
including a pseudovirus neutralization assay (pseudotyped
lentivirus reporter single-round-of-infection neutralization assay
[PsVNA]) against the two most common SARS-CoV-2 variants (614D and
614G) and three live-virus neutralization assays (SARS-CoV-2
nanoluciferase high-throughput neutralization assay [nLUC HTNA],
focus reduction neutralization test mNeonGreen [FRNT-mNG] and
classical plaque-reduction neutralization test [PRNT]). No
participants had detectable neutralizing responses by any assay
prior to vaccination, and robust neutralizing activity was observed
in all participants 14 days after the second vaccination.
Psuedovirus neutralization responses were observed as early as
seven days after the second vaccination and were dose-dependent
across all age groups (18-55, 56-70 and 71+). At Day 43 at the 100
μg dose level, PsVNA ID50 titers in the older adult cohorts ages
56-70 (GMT 402) and 71+ (GMT 317) were comparable to those seen in
the age 18-55 cohort (GMT 360), and 3- to 4-fold higher than those
seen in convalescent sera (GMT 106). Titers remained high through
four weeks after the second dose in all age cohorts. Neutralizing
activity against the 614G variant was also observed at the 100 μg
dose in all age cohorts.
Results were consistent using 3 live virus assays. Neutralizing
antibody titers as measured by nLUC HTNA and FRNT-mNG were similar
across all age groups (18-55, 56-70 and 71+). At Day 43, PRNT80 GMT
in the 100 ug dose groups was 878 in the 56-70 and 317 in the 71+
age cohort, representing 5.5 and 2.0-fold above convalescent sera
respectively, and 4.1-fold above convalescent sera in the 18-55 age
group (GMT 654).
The 25 µg dose in the 56-70 age cohort and the 100 µg dose level
across all age groups (18-55, 56-70 and 71+) elicited a strong
Th1-biased CD4 T cell response.
The U.S. government has purchased 100 million doses of
mRNA-1273, with an option to purchase an additional 400 million
doses.
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 the National
Institute of Allergy and Infectious Disease’s (NIAID) 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 the National Institutes of Health (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. On May 29, the first
participants in each age cohort: healthy adults ages 18-55 years
(n=300) and older adults ages 55 years and above (n=300) were dosed
in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study
completed enrollment.
The Phase 3 COVE study of mRNA-1273, being conducted in
collaboration with the NIH and BARDA, began on July 27. Results
from a non-human primate preclinical viral challenge study
evaluating mRNA-1273 were recently published in The New England
Journal of Medicine. On July 14, an interim analysis of the
original cohorts in the NIH-led Phase 1 study of mRNA-1273 was
published in The New England Journal of Medicine. A summary of the
company’s work to date on COVID-19 can be found here.
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), is supporting the continued
research and development of mRNA-1273 with $955 million in federal
funding under Contract no. 75A50120C00034. BARDA is reimbursing
Moderna for 100 percent of the allowable costs incurred by the
company for conducting the program described in the BARDA contract.
The U.S. government has committed $1.525 billion to purchase supply
of mRNA-1273 under U.S. Department of Defense Contract No.
W911QY-20-C-0100.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines
modality to prevent infectious diseases. More than 1,900
participants, prior to enrolling the Phase 3 study of mRNA-1273,
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 vaccine (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. 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, cardiovascular diseases, and
autoimmune and inflammatory 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; 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) and the Coalition for Epidemic
Preparedness Innovations (CEPI). Moderna has been named a top
biopharmaceutical employer by Science 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, but not limited to, statements
concerning the potential for mRNA-1273 to generate binding and
neutralizing antibodies in older adults, the potential for adverse
side effects from mRNA-1273, and the timing for the completion of
enrollment for the Phase 3 COVE study of mRNA-1273.. 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: 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 commercial product using mRNA
technology has been approved, 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; despite having ongoing interactions with the FDA or
other regulatory agencies, the FDA or such other regulatory
agencies may not agree with the Company’s regulatory approval
strategies, components of our filings, such as clinical trial
designs, conduct and methodologies, or the sufficiency of data
submitted; 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 clinical trials, preclinical work, overall operations,
regulatory review, manufacturing and supply chain interruptions,
adverse effects on healthcare systems and disruption of the global
economy; and those 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/20200929006145/en/
Media: Colleen Hussey Senior Manager, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
Moderna (NASDAQ:MRNA)
Historical Stock Chart
From Apr 2024 to May 2024
Moderna (NASDAQ:MRNA)
Historical Stock Chart
From May 2023 to May 2024