Positive interim analysis from Phase 2 study of
CMV vaccine candidate (mRNA-1647); Phase 3 study to begin in
2021
Phase 3 COVE study of COVID vaccine candidate
(mRNA-1273) has enrolled 25,296 participants to date; Phase 3
protocol now available online
Moderna to enter seasonal flu business given
the high medical need for more effective flu vaccine
Two-dose regimen of Chikungunya antibody
(mRNA-1944) demonstrates the platform’s ability for safe repeat
dosing
Next generation MMA candidate (mRNA-3705)
announced
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines to create a new
generation of transformative medicines for patients, announced
progress across its portfolio of pipeline assets being presented at
the Company’s annual R&D Day today.
“The Moderna team has made significant progress since our last
R&D Day 12 months ago. The pipeline has matured with our
COVID-19 vaccine in a Phase 3 study and four candidates in Phase 2
studies. We are actively preparing for a potential commercial
launch of mRNA-1273, our COVID-19 vaccine, and we continue to
expand the breadth of Moderna’s platform,” said Stéphane Bancel,
Moderna’s Chief Executive Officer. “We are announcing that we are
increasing our investment in vaccines and we will develop a
seasonal flu vaccine given the unmet need for highly effective
vaccines. In our systemic secreted & cell surface therapeutics
core modality, we are sharing positive interim data for repeat
dosing of our systemic mRNA therapeutic against chikungunya, which
is important progress for our therapeutics modalities, particularly
in rare diseases. With our second collaboration with Vertex, we are
entering the field of gene editing using Moderna’s technology. As
we continue to scale for commercialization, we are more committed
than ever to our mission to deliver on the promise of mRNA
medicines to treat or prevent serious diseases.”
Presentation highlights from Moderna’s R&D Day
include:
Infectious Diseases
- COVID vaccine candidate (mRNA-1273) Phase 3 COVE study of
30,000 volunteers in the U.S. being conducted with NIH and BARDA
has enrolled 25,296 participants as of September 16, 2020; 10,025
participants have received their second vaccination to date; to
provide additional transparency in context of pandemic, Phase 3
protocol now available online
- Positive interim analysis from Phase 2 study of CMV vaccine
candidate (mRNA-1647); Phase 3 study of mRNA-1647 to begin in 2021
at 100 μg dose
- The U.S. Food and Drug Administration (FDA) has completed its
review of the Investigational New Drug (IND) application for the
Company’s pediatric RSV vaccine (mRNA-1345) and allowed it to
proceed to the clinic
- First 10 pediatric patients dosed in Phase 1 study of hMPV/PIV3
vaccine (mRNA-1653)
- Moderna plans to enter the seasonal flu business
Oncology
- Data from Phase 1 study of OX40L(mRNA-2416) as a monotherapy
were presented at the American Association for Cancer Research
Annual Meeting; first patients dosed in Phase 2 dose expansion
study of mRNA-2416 in combination with durvalumab for ovarian
cancer
Rare Diseases
- Positive data from additional cohorts of Phase 1 study
evaluating escalating doses of antibody against the chikungunya
virus (mRNA-1944) administered via intravenous infusion in healthy
adults
- New next generation MMA candidate (mRNA-3705) protocol revision
to enhance operational performance and improve outreach to the
patient community
- New protocol amendment for Phase 1/2 study of propionic
acidemia (PA) candidate (mRNA-3927)
Moderna currently has 23 mRNA development candidates in its
portfolio with 14 in clinical studies. Across Moderna’s pipeline,
more than 27,000 healthy volunteers and patients have been enrolled
in clinical studies including the Phase 3 study of mRNA-1273. The
Company’s updated pipeline can be found at
www.modernatx.com/pipeline. Moderna and collaborators have
published more than 50 peer-reviewed papers.
About Moderna’s R&D Day Presentation
Core Modalities
Prophylactic Vaccines: Moderna is developing vaccines
against viral diseases where there is unmet medical need –
including complex vaccines with multiple antigens for common
diseases, as well as vaccines against threats to global public
health. The Company’s global public health portfolio is focused on
epidemic and pandemic diseases for which funding has been sought
from governments and non-profit organizations.
- Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive
interim data from Phase 2 study assessing the safety,
reactogenicity, and immunogenicity of different dose levels of
mRNA-1647 are now available. mRNA-1647 was generally safe and well
tolerated. After the first vaccination, injection site pain was the
most commonly reported solicited local adverse reaction (AR). The
most common solicited systemic ARs were headache, fatigue, and
myalgia in both CMV-seronegative and CMV-seropositive mRNA-1647
treatment groups. No serious adverse events (SAEs) were reported
and no unsolicited events leading to study discontinuation
occurred. After the 2nd vaccination, the rate and severity
distribution of solicited ARs in the CMV-seronegative and
CMV-seropositive mRNA-1647 treatment groups were generally similar.
In CMV-seronegative participants, neutralizing antibody titers
against epithelial cell infection were boosted to at least 12-fold
over the baseline geometric mean titer (GMT) of CMV-seropositive
participants. Neutralizing antibody titers against fibroblast
infection were generally equivalent to the baseline GMT in
CMV-seropositive participants. In CMV-seropositive participants,
neutralizing antibody titers in the epithelial cell infection were
boosted to GMTs at least 20-fold to greater than 32-fold over the
respective baseline GMT after the 2nd vaccination. Neutralizing
antibody titers against fibroblast infection boosted to levels at
least 2-fold over the respective baseline GMT. Based on the interim
analysis of the Phase 2 study, the 100 μg dose has been chosen for
the Phase 3 pivotal study, expected to begin in 2021. Moderna owns
worldwide commercial rights for mRNA-1647.
- COVID-19 vaccine (mRNA-1273): As of Wednesday, September
16, 2020, 25,296 participants have been enrolled in the Phase 3
COVE study and approximately 28% of participants enrolled
cumulatively are from diverse communities. 10,025 participants have
received their second vaccination. The protocol for the study being
conducted in collaboration with the NIH and BARDA is now publicly
available. On July 14, an interim analysis of the original cohorts
in the NIH-led Phase 1 study evaluating a two-dose vaccination
schedule of mRNA-1273 across three dose levels (25, 100, 250 µg) in
45 healthy adults ages 18-55 years was published in The New England
Journal of Medicine and shows mRNA-1273 induced rapid and strong
immune responses against SARS-CoV-2. mRNA-1273 was generally safe
and well tolerated with no SAEs reported through Day 57. 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.
- Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3)
vaccine (mRNA-1653): The first 10 seropositive pediatric
participants (12-36 months of age) in the Phase 1 study of
hMPV/PIV3 study (mRNA-1653) were dosed prior to the COVID-19
related study disruption. Sites have re-opened and are actively
recruiting participants. Moderna owns worldwide commercial rights
to mRNA-1653.
- Pediatric respiratory syncytial virus (RSV) vaccine
(mRNA-1345): The FDA has completed its review of the
Investigational New Drug (IND) application for mRNA-1345 and
allowed it to proceed to clinic. mRNA-1345 is a vaccine against RSV
in young children encoding for a prefusion F glycoprotein, which
elicits a superior neutralizing antibody response compared to the
postfusion state. The Company intends to combine mRNA-1345 with
mRNA-1653, its vaccine against hMPV and PIV3, to create a
combination vaccine against RSV, hMPV and PIV3. There is no
approved vaccine for RSV. Moderna owns worldwide commercial rights
to the combined mRNA-1345/mRNA-1653 vaccine.
- Seasonal influenza (flu): Moderna is entering the
seasonal flu business. Seasonal flu (type A and type B) epidemics
occur seasonally and vary in severity each year, causing
respiratory illnesses and placing substantial burden on healthcare
systems. Currently approved vaccines are ~40-60% effective and face
significant challenges from strain mismatch1; high-risk groups
would benefit from higher efficacy, which the Company believes its
mRNA platform may be capable of delivering.
Systemic Secreted & Cell Surface Therapeutics: In
this modality, mRNA is delivered systemically to create proteins
that are either secreted or expressed on the cell surface.
- Antibody against the chikungunya virus (mRNA-1944):
Positive interim data from the Phase 1 study evaluating escalating
doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication
cohort and two doses of 0.3 mg/kg (without steroid premedication)
given one week apart cohort are now available. mRNA-1944 was
generally safe and well tolerated. No SAEs were reported; the most
common adverse events were headache, nausea, myalgia, dizziness and
chills. Administration of mRNA-1944 resulted in dose-dependent
increases in levels of antibody against chikungunya (CHKV-24).
Neutralizing antibodies were observed at all dose levels,
indicating functional antibody production by mRNA-1944. Safety and
increased CHKV-IgG production in the two-dose regimen shows the
platform’s ability for repeat dosing.
Exploratory Modalities
Intratumoral Immuno-Oncology: These programs aim to drive
anti-cancer T cell responses by injecting mRNA therapies directly
into tumors.
- OX40L (mRNA-2416): The Phase 1/2 study of mRNA-2416
alone and in combination with durvalumab (IMFINZI®) is ongoing. The
Phase 2 dose expansion study of mRNA-2416 in combination with
durvalumab in ovarian cancer patients is enrolling and the first
patients have been dosed. Data from the Phase 1 study evaluating
mRNA-2416 as a monotherapy were presented at the American
Association for Cancer Research Annual Meeting and show mRNA-2416
is well tolerated when given as monotherapy at all dose levels
studied with no dose-limiting toxicities reported. The observations
of broad pro-inflammatory activity and beneficial changes in the
tumor microenvironment with upregulation of PD-L1 support the
evaluation of combination intratumoral mRNA-2416 with the
anti-PD-L1 inhibitor durvalumab in solid tumors, which is ongoing
in Part B of this study with a focus on advanced ovarian carcinoma.
Moderna owns worldwide commercial rights to mRNA-2416.
Systemic Intracellular Therapeutics: These programs aim
to deliver mRNA into cells within target organs as a therapeutic
approach for diseases caused by a missing or defective protein.
- Methylmalonic acidemia (MMA) (mRNA-3704): Due to the
COVID-19 pandemic, Moderna paused new enrollment and new site
initiation for the Phase 1/2 study of mRNA-3704 to ensure the
safety of these pediatric patients and their caregivers. During the
pause, the Company implemented changes that the Company believes
will ultimately help to accelerate clinical development including
the introduction of a new drug product with better pharmacology
(designated mRNA-3705) as well as a protocol revision to enhance
operational performance and reflecting input from the patient and
caregiver community. The Company plans to file new IND and CTA
applications for mRNA-3705 and will focus development efforts on
that candidate going forward. mRNA-3705 uses the same LNP
formulation as mRNA-1944. Moderna owns worldwide commercial rights
to mRNA-3705.
- Propionic acidemia (PA) (mRNA-3927): Due to the COVID-19
pandemic, Moderna paused new enrollment and new site initiation for
its Phase 1/2 study of mRNA-3927 to ensure the safety of these
pediatric patients and their caregivers. During the pause, the
Company implemented changes that the Company believes will
ultimately help to accelerate clinical development including a
protocol amendment implementing a novel design to identify the
optimal dose in the most efficient manner and to make the study
less burdensome on patients, their families and clinical partners.
mRNA-3927 uses the same LNP formulation as mRNA-1944. Moderna owns
worldwide commercial rights to mRNA-3927.
Corporate Updates
- Moderna announced a new research collaboration with Vertex to
discover potential treatment of cystic fibrosis using gene editing
enabled by Moderna’s mRNA and lipid technologies
- Moderna announced a collaboration with Chiesi Group to discover
and develop mRNA therapeutics for pulmonary arterial hypertension
(PAH)
Investor Call and Webcast Information
Moderna will host the virtual R&D Day beginning at 8:00 a.m.
ET on Thursday, September 17, 2020. A live webcast will be
available under “Events and Presentations” in the Investors section
of the Moderna website at investors.modernatx.com. A replay of the
webcast will be archived on Moderna’s website for one year
following the presentation.
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 statements regarding: expected timing
of enrollment completion for the Phase 3 study of mRNA-1273; the
timing and design of the Phase 3 study of mRNA-1647; the Company’s
intention to create a combination therapy with mRNA-1345 and
mRNA-1653 against RSV, hMPV and PIV3; the Company’s plans to file
new IND and CTA applications for mRNA-3705; the Company’s
intentions regarding resumption of enrollment and the
implementation of changes for paused clinical studies; the
probability of success of the Company’s vaccines individually and
as a portfolio; the Company’s intention to enter the seasonal flu
business; the Company’s development of mRNA-3705 as a next
generation MMA candidate; and the ability of the Company to
accelerate the research and development timeline for any individual
product or the platform as a whole. 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: 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.
1 Centers for Disease Control and Prevention. Vaccine
Effectiveness: How Well Do the Flu Vaccines Work? Available at:
https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm.
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Moderna Contacts
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
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