Seasonal flu vaccine program will cover four
seasonal viruses recommended by the World Health Organization
(WHO)
HIV vaccine program to accelerate human
validation of novel vaccination strategies
Nipah vaccine program established against a
virus of public health concern
Moderna now has one commercial medicine and 24
development programs
Multiple therapeutic programs anticipated to
see clinical proof of concept data in 2021
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that it is expanding its pipeline of innovative vaccines with three
new development programs based on the clinical success of its
infectious disease vaccine portfolio to date. This announcement
reflects the Company’s commitment to accelerating its infectious
disease portfolio based on Moderna’s experience with its COVID-19
vaccine. The development programs announced today are mRNA vaccine
candidates against seasonal flu, HIV and the Nipah virus. Moderna
also announced an expansion of its respiratory syncytial virus
(RSV) vaccine program into older adults.
“The uniquely challenging year of 2020 for all of society proved
to be an extraordinary proof-of-concept period for Moderna,” said
Stéphane Bancel, Moderna’s chief executive officer. “Even as we
have shown that our mRNA-based vaccine can prevent COVID-19, this
has encouraged us to pursue more-ambitious development programs
within our prophylactic vaccines modality. Today we are announcing
three new vaccine programs addressing seasonal flu, HIV and the
Nipah virus, some of which have eluded traditional vaccine efforts,
and all of which we believe can be addressed with our mRNA
technology. Beyond vaccines, we are extending our mRNA development
work to a total of 24 programs across five therapeutic areas.”
Mr. Bancel will present an update on the Company and its
pipeline of mRNA development programs on Monday, January 11, 2021
at 4:30 p.m. ET at the 39th Annual J.P. Morgan Healthcare
Conference. The presentation will be followed by a
question-and-answer session. A live webcast of both the
presentation and question and answer session will be available
under “Events & Presentations” in the investors section of
Moderna’s website at investors.modernatx.com. A replay of the
webcast will be archived on Moderna’s website for 30 days following
the presentation.
Moderna currently has 24 mRNA development programs in its
portfolio with 13 having entered the clinic. The Company’s updated
pipeline can be found at www.modernatx.com/pipeline.
About Moderna’s New Infectious Disease Vaccine Development
Programs
- Flu vaccine (mRNA-1010, mRNA-1020, mRNA-1030): 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. The WHO estimates
globally about 3,000,000-5,000,000 severe cases of flu each year,
and 290,000-650,000 flu-related respiratory deaths. Approximately
8% of the U.S. population experiences symptoms from flu each year
in the US, with 140,000-810,000 hospitalizations and 12,000-61,000
deaths per year. Peak flu activity is seen in temperate climates
from fall to winter and is reflected in increases in outpatient
visits, urgent care visits, and hospitalizations. In the U.S., the
estimated average economic burden of flu is approximately $11
billion per year. The Company plans to explore potential
combination vaccines against flu, SARS-CoV-2, RSV and human
metapneumovirus (hMPV). The Company’s first-generation flu program
will evaluate multiple candidates comprising multiple antigen
combinations against the four seasonal viruses recommended by the
WHO. The Company expects to begin phase 1 clinical trials for the
program in 2021.
- HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the
virus responsible for acquired immunodeficiency syndrome (AIDS), a
lifelong, progressive illness with no effective cure. Approximately
38 million people worldwide are currently living with HIV with 1.2
million in the U.S. Approximately 2 million new infections of HIV
are acquired worldwide every year and approximately 690,000 people
die annually due to complications from HIV/AIDS. The primary routes
of transmission are sexual intercourse and IV drug use, putting
young adults at the highest risk of infection. From 2000 to 2015, a
total of $562.6 billion globally was spent on care, treatment and
prevention of HIV, representing a significant economic burden.
mRNA-1644, a collaboration with the International AIDS Vaccine
Initiative (IAVI) and the Bill and Melinda Gates Foundation (BMGF),
is a novel approach to HIV vaccine strategy in humans designed to
elicit broadly Neutralizing HIV-1 Antibodies (bNAbs). A Phase 1
study for mRNA-1644 will use iterative human testing to validate
the approach and antigens and multiple novel antigens will be used
for germline-targeting and immuno-focusing. A second approach,
mRNA-1574, is being evaluated in collaboration with the National
Institutes of Health (NIH) and includes multiple native-like trimer
antigens. The Company expects to begin phase 1 clinical trials for
both mRNA-1644 and mRNA-1574 in 2021.
- Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic
virus transmitted to humans from animals, contaminated food, or
through direct human-to-human transmission and causes a range of
illnesses including fatal encephalitis. Severe respiratory and
neurologic complications of NiV have no treatment other than
intensive supportive care. The case fatality rate among those
infected is estimated at 40-75%. NiV outbreaks cause significant
economic burden to impacted regions due to loss of human life and
interventions to prevent further spread, such as the slaughter of
infected animals. NiV has been identified as the cause of isolated
outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000
and is included on the WHO R&D Blueprint list of epidemic
threats needing urgent R&D action. mRNA-1215 was co-developed
by Moderna and the NIH’s Vaccine Research Center (VRC).
Moderna’s pipeline is organized into six modalities based on
similar mRNA technologies, delivery technologies and manufacturing
processes. The Company’s approach is to leverage early programs
within a modality to generate clinical data and insights that
reduce the technology risk of subsequent programs and accelerate
the expansion of the pipeline in that modality. Positive phase 1, 2
and 3 data from Moderna’s infectious disease vaccine portfolio and
positive phase 1 data from its chikungunya antibody program have
de-risked its prophylactic vaccines and systemic therapeutics &
cell surface modalities respectively. Beyond these core modalities,
the Company has four exploratory modalities in which it is actively
pursuing clinical proof of concept.
Summary of Program Updates by Modality:
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 and often developed in
collaborations with governments and non-profit organizations.
Vaccines requiring complex antigens and against highly prevalent
infections
- Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive
interim data from the phase 2 study assessing the safety,
reactogenicity, and immunogenicity of different dose levels of
mRNA-1647 were presented at Moderna’s annual R&D Day. Based on
the interim analysis of the phase 2 study, the 100 μg dose has been
chosen for the phase 3 pivotal study, which is expected to begin
this year. Moderna owns worldwide commercial rights for
mRNA-1647.
- Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189
is a vaccine against EBV containing five mRNAs that encode viral
proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna’s
CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are
expressed in their native membrane-bound form for recognition by
the immune system. There is no approved vaccine for EBV. Moderna
owns worldwide commercial rights to mRNA-1189.
Vaccines against respiratory infections
- Moderna COVID-19 Vaccine (mRNA-1273) authorization: On
December 18, the U.S. Food and Drug Administration (FDA) authorized
the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19,
in individuals 18 years of age or older. The Moderna COVID-19
Vaccine is also authorized by Canada, Israel, the United Kingdom
and the European Union. Additional authorizations are currently
under review in additional markets including Singapore, Switzerland
and by the WHO. On December 30, interim safety and primary efficacy
results from the Phase 3 trial of the Moderna COVID-19 Vaccine
(mRNA-1273) were published in the New England Journal of Medicine.
The primary endpoint of the Phase 3 COVE study was based on the
analysis of COVID-19 cases confirmed and adjudicated starting two
weeks following the second dose of vaccine. This final analysis was
based on 196 cases, of which 185 cases of COVID-19 were observed in
the placebo group versus 11 cases observed in the Moderna COVID-19
Vaccine group, corresponding to a 94% vaccine efficacy (95% CI
89.3-96.8%; p<0.0001). The most common solicited adverse
reactions (ARs) after the two-dose series was injection site pain
(86.0%). Solicited systemic adverse events occurred more often in
the Moderna COVID-19 vaccine group (54.9% and 79.4%) than in the
placebo (42.2% and 36.5%) group after both the first dose and the
second dose respectively and were most commonly headache, fatigue
and myalgia. While the majority of these ARs were mild (grade 1) or
moderate (grade 2), there was a higher occurrence of severe (grade
3) reactions in the Moderna COVID-19 Vaccine group after the first
(2.9%) and second (15.8%) injections. The majority of local
solicited ARs occurred within the first one to two days after
injection and generally persisted for a median of one to two days.
Safety data continues to accrue, and the study continues to be
monitored by an independent Data Safety Monitoring Board (DSMB)
appointed by the NIH. All participants in the COVE study will be
monitored for two years after their second dose to assess long-term
protection and safety. Additional data to be collected will include
longer term safety follow-up, duration of protection against
COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection.
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. Moderna retains worldwide rights to
develop and commercialize mRNA-1273.
- Moderna COVID-19 Vaccine (mRNA-1273) additional clinical
studies: Moderna is also conducting a phase 2/3 study of the
Moderna COVID-19 Vaccine in adolescents 12 to under 18 years of
age. Additional studies are planned to evaluate the Moderna
COVID-19 Vaccine in pregnant women, children younger than 12 years,
and those in special risk groups, such as the
immunocompromised.
- Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3)
vaccine (mRNA-1653): Sites have resumed dosing seropositive
pediatric participants (12-36 months of age) in the Phase 1 study
of hMPV/PIV3 study (mRNA-1653) following the COVID-19 related study
disruption. Moderna owns worldwide commercial rights to
mRNA-1653.
- Respiratory syncytial virus (RSV) vaccine (mRNA-1345):
mRNA-1345 is a vaccine against RSV encoding for a prefusion F
glycoprotein, which elicits a superior neutralizing antibody
response compared to the postfusion state. The first cohort of the
phase 1 study of mRNA-1345 is fully enrolled. This phase 1 study
includes initial dosing in younger adults, followed by age
de-escalation into children. The Company today, announced its plan
to amend the protocol to include evaluation of mRNA-1345 in older
adults who are also at risk of significant RSV disease. Going
forward, the Company intends to evaluate the potential of
combinations of mRNA-1345 with its vaccines against other
respiratory pathogens in children and separately in older adults.
There is no approved vaccine for RSV. Moderna owns worldwide
commercial rights to mRNA-1345.
Public Health Vaccines
- Zika virus vaccine (mRNA-1893): All dose cohorts (10,
30, 100 and 250 µg) in the phase 1 study of mRNA-1893 have
completed enrollment. Moderna is preparing for a phase 2 study of
mRNA-1893. mRNA-1893 is being developed in collaboration with the
U.S. Biomedical Advanced Research and Development Authority (BARDA)
within the Office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services.
Moderna owns worldwide commercial rights to mRNA-1893.
- Pandemic influenza/H7N9 vaccine (mRNA-1851): Discussions
regarding funding the Company’s pandemic influenza/H7N9 vaccine
program through approval are ongoing.
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 were presented at Moderna’s annual
R&D Day and demonstrated dose-dependent increases in levels of
antibody against chikungunya. Safety and increased CHKV-IgG
production in the two-dose regimen shows the platform’s ability for
repeat dosing.
Exploratory Modalities
Cancer Vaccines: These programs focus on stimulating a
patient’s immune system with antigens derived from tumor-specific
mutations to enable the immune system to elicit a more effective
anti-tumor response.
- Personalized cancer vaccine (PCV) (mRNA-4157): The
randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in
combination with Merck’s pembrolizumab (KEYTRUDA®), compared to
pembrolizumab alone, for the adjuvant treatment of high-risk
resected melanoma is ongoing. The Phase 1 study is ongoing. Moderna
shares worldwide commercial rights to mRNA-4157 with Merck.
- Presentation of Note: Interim data from the phase 1 dose
expansion cohort of mRNA-4157 in combination with pembrolizumab was
shared at The Society for Immunotherapy of
Cancer’s Annual Meeting 2020 and supported the expansion of
the Head and Neck Squamous Cell Carcinoma (HNSCC) cancer patient
cohort.
- Mutant KRAS vaccine (mRNA-5671 or V941): The phase 1
open-label, multi-center study to evaluate the safety and
tolerability of mRNA-5671 both as a monotherapy and in combination
with pembrolizumab, led by Merck, is ongoing. Moderna shares
worldwide commercial rights to mRNA-5671 with Merck.
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. Moderna owns worldwide commercial rights
to mRNA-2416.
- OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The phase 1
trial evaluating mRNA-2752 as a single agent and in combination
with durvalumab in patients with advanced solid tumor malignancies
and lymphoma is ongoing. mRNA-2752 is an investigational mRNA
immuno-oncology therapy that encodes a novel combination of three
immunomodulators. Moderna owns worldwide commercial rights to
mRNA-2752.
- IL-12 (MEDI1191): The phase 1 open-label, multi-center
study of intratumoral injections of MEDI1191 alone and in
combination with durvalumab in patients with advanced solid tumors,
led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for
IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide
commercial rights to MEDI1191 with AstraZeneca.
Localized Regenerative Therapeutics: Localized production
of proteins has the potential to be used as a regenerative medicine
for damaged tissues.
- VEGF-A (AZD8601): The phase 2a study of AZD8601 VEGF-A,
which is being developed for patients with ischemic heart disease
undergoing coronary artery bypass grafting (CABG) surgery with
moderately impaired systolic function, led by AstraZeneca, is
ongoing. Moderna has licensed worldwide commercial rights to
AZD8601 to AstraZeneca.
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.
- Propionic acidemia (PA) (mRNA-3927): Sites are being
initiated, with entry into the clinic expected in 2021. The Company
will be looking for biomarkers as early indicators for therapeutic
impact. Moderna owns worldwide commercial rights to mRNA-3927.
Information about each development candidate in Moderna’s
pipeline, including those discussed in this press release, can be
found on the investor relations page of Moderna’s website:
https://investors.modernatx.com.
Corporate Updates
- Continued growth across organization: Moderna ended 2020
with approximately 1,300 full time employees, an increase from
approximately 820 full time employees at the end of 2019. Moderna
was named a top employer by Science for the sixth year in a
row.
- Announced additions to the Moderna team:
- Corinne Le Goff, Pharm.D., MBA, will join Moderna as
Chief Commercial Officer effective Tuesday, January 19, 2021. Dr.
Le Goff served as senior vice president and president of the U.S.
Business Organization at Amgen (Nasdaq: AMGN). Prior to that, Dr.
Le Goff held a number of senior international roles at Roche Group
(SWX: RO), including President of Roche France and Global Product
Strategy Head of Neuroscience & Rare Diseases, and leadership
roles at Sanofi (Nasdaq: SNY) and Pfizer (NYSE: PFE) in the United
States.
- Ruchira Glaser, M.D., MSCE, joined Moderna as the Senior
Vice President, Therapeutic Area Head for the Rare Disease,
Autoimmune, and Cardiovascular Therapeutic Areas, where she will
oversee development for our broad therapeutics portfolio outside of
oncology. Dr. Glaser joins from GlaxoSmithKline (NYSE: GSK), where
she was most recently Head of Clinical Sciences for the Respiratory
and Specialty areas, including rare diseases, immunology and
anemia. Prior to that, Dr. Glaser spent 10 years as an
interventional cardiologist and clinical researcher at the
University of Pennsylvania.
- Continued strong cash position: The Company expects
cash, cash equivalents, and investments as of December 31, 2020 to
be approximately $5.25 billion (unaudited), as compared to $1.26
billion as of December 31, 2019, including customer deposits of
$2.81 billion for future supply of product.
- Moderna has signed Advance Purchase Agreements (APAs) for
the delivery of its COVID-19 Vaccine. To date, the product
revenue associated with these APAs for FY 2021 is $11.7 billion.
These doses of Moderna COVID-19 Vaccine are expected to be
delivered in 2021. The company is in active discussions to sign
additional APAs for deliveries in 2021 and 2022. Moderna has also
made a proposal to COVAX via a UNICEF tender to supply low-and-mid
income countries.
- Commitment to access: The Company published seven
principles as part of its Commitment to Vaccines and Therapeutics
Access.
- Shareholder Letter: Moderna CEO Stéphane Bancel
published a letter to shareholders on January 4, 2021.
Key 2021 Investor and Analyst Event Dates
- Vaccines Day– April 14
- Science Day – May 27
- R&D Day – September 9
About Moderna In 10 years since its inception, Moderna
has transformed from a science research-stage company advancing
programs in the promising-but-still-unproven field of messenger RNA
(mRNA), to an enterprise with its first medicine having treated
millions of people, a diverse clinical portfolio of vaccines and
therapeutics across six modalities, a broad intellectual property
portfolio in areas including mRNA and lipid nanoparticle
formulation, and an integrated manufacturing plant that allows for
both clinical and commercial production at scale and at
unprecedented speed. Moderna maintains alliances with a broad range
of domestic and overseas government and commercial collaborators,
which has allowed for the pursuit of both groundbreaking science
and rapid scaling of manufacturing. Most recently, Moderna’s
capabilities have come together to allow the authorized use of one
of the earliest and most-effective vaccines against the COVID-19
pandemic.
Moderna’s mRNA platform builds on continuous advances in basic
and applied mRNA science, delivery technology and manufacturing,
and has allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases and auto-immune diseases. Today, 24 development programs
are underway across these therapeutic areas, with 13 programs
having entered the clinic. Moderna has been named a top
biopharmaceutical employer by Science for the past six 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: development programs for vaccines against
influenza, HIV and the Nipah virus and the specifics of those
programs, including the timing of potential clinical trials; the
timing for receipt of proof of concept clinical data from multiple
therapeutics; the potential advantages of infectious disease
vaccines; the development of combination vaccines against multiple
diseases; the conduct of studies for the Company’s vaccines against
CMV, Zika virus, anti-cancer vaccines (i.e., OX40L,
OX40L/IL-23/IL-36γ and IL-12), VEGF-A and PA; the potential for the
Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the
spread of SARS-CoV-2, the safety profile for the Moderna COVID-19
Vaccine; plans for further clinical trials for the Moderna COVID-19
Vaccine; the potential for repeat dosing of certain therapeutics;
the Company’s plans for research and development and timelines for
any individual product or the platform as a whole; cash, cash
equivalents and investment balances; and discussions related to
further sales of the Moderna COVID-19 Vaccine. 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 safety, tolerability and efficacy profile of the
Moderna COVID-19 Vaccine observed to date may change adversely in
ongoing analyses of trial data or subsequent to commercialization;
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; Moderna
may encounter delays in meeting manufacturing or supply timelines
or disruptions in its distribution plans for the Moderna COVID-19
Vaccine; whether and when any biologics license applications and/or
emergency use authorization applications may be filed and
ultimately approved by regulatory authorities; 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/20210111005580/en/
Moderna Contacts:
Media: Colleen Hussey Director, Corporate
Communications 617-335-1374
Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Senior Vice President
& Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
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