hMPV+PIV3: Phase 1 data show first combination
vaccine against respiratory viruses hMPV and PIV3 (mRNA-1653)
boosted hMPV and PIV3 neutralizing antibody titers above baseline
through seven months; safety analysis at two months shows mRNA-1653
generally well-tolerated at all dose levels
Zika: Preclinical data show Zika vaccine
(mRNA-1893) protective against Zika virus transmission during
pregnancy in mice; mRNA-1893 is currently being evaluated in a
Phase 1 study
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 data presentations regarding two of its
wholly owned prophylactic mRNA vaccines at IDWeek in Washington,
D.C. The presentations include interim Phase 1 data from its
combination vaccine against the respiratory viruses human
metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) (mRNA-1653)
and preclinical data from its Zika vaccine (mRNA-1893).
Presentation Details
Abstract 2754: Phase 1 Trial of an mRNA-based Combination
Vaccine Against hMPV and PIV3 Presented by: Christine Shaw, Ph.D.,
Senior Director of Translational Research, Infectious Diseases,
Moderna (Poster Presentation, Saturday, October 5, 12:15 p.m. –
1:30 p.m. ET)
Abstract 2904: Protective Efficacy of Nucleic Acid Vaccines
Against Transmission of Zika Virus During Pregnancy in Mice
Presented by: Brett W. Jagger, M.D., Ph.D., Infectious Diseases
Fellow, Washington University (Oral Presentation, Saturday, October
5, 4:00 p.m. – 4:15 p.m. ET)
The IDWeek presentations will be available on the “Events and
Presentations” section of our website.
hMPV+PIV3 Vaccine (mRNA-1653) Phase 1 Data
Results from the second pre-planned interim analysis of the
Phase 1 study of mRNA-1653 in healthy seropositive adults show that
vaccination with mRNA-1653 led to hMPV and PIV3 antibody levels
above baseline that persisted through seven months. The study is
one of the six positive Phase 1 readouts Moderna has announced from
its prophylactic vaccines portfolio to date.
“These promising data demonstrate the potential of mRNA-1653 to
provide protection against both hMPV and PIV3, two viruses that can
cause severe respiratory diseases in infants and children and
currently have no approved vaccines,” said Tal Zaks, M.D., Ph.D.,
chief medical officer at Moderna. “Our hMPV+PIV3 program is one of
several in development focused on preventing respiratory illnesses
and addressing unmet needs. We look forward to evaluating mRNA-1653
in a Phase 1b study in toddlers who have previously been exposed to
these viruses.”
In the study, all participants had neutralizing antibodies
against both viruses at baseline (seropositive), consistent with
prior exposure. The first interim analysis showed a single dose of
mRNA-1653 boosted hMPV and PIV3 neutralization titers, and the
magnitude of this boost was similar at all dose levels tested.
There was an inverse relationship between baseline neutralizing
antibody titer and the response to the first mRNA-1653 vaccination
(Day 28 / Day 1 titer ratio), particularly for PIV3, regardless of
dose. A second dose of mRNA-1653 was not associated with further
increase of hMPV and PIV3 neutralization titers.
Safety data from the first interim analysis showed mRNA-1653 was
generally well-tolerated at all dose levels. The most common
solicited local adverse event (AE) was injection site pain. More
severe (Grade 3) injection site pain events occurred after the
first vaccination overall and at the 300 µg dose. The most common
solicited systemic AEs were headache, fatigue and myalgia, and
appeared to increase with dose level. No serious AEs (SAEs), AEs of
special interest or AEs leading to withdrawal were reported.
In August 2019, the Company announced that a potential path
forward to evaluate protection against both hMPV and PIV3 in a
single Phase 3 study was discussed in a recent type C meeting with
the U.S. Food and Drug Administration (FDA). Consistent with this
development path, Moderna is planning to initiate a Phase 1b study
of mRNA-1653 in seropositive toddler participants as the next
step.
hMPV was discovered in 2001 as the cause of acute respiratory
infections in up to 15 percent of patients. The virus primarily
affects young children but can also infect adults, the elderly and
those who are immunocompromised. Symptoms range from a mild upper
respiratory tract infection to life-threatening severe
bronchiolitis and pneumonia. Despite the need, there is currently
no approved vaccine for hMPV.
Infections from PIV account for up to seven percent of acute
respiratory infections among children younger than five years of
age. Of the four PIV types identified, PIV3 most frequently results
in infections and leads to more serious lower respiratory tract
infections. Though PIV3-related infections were identified in the
past, their burden to patients and hospitals has been elevated over
the past few years. There is currently no approved vaccine for
PIV3.
Zika Vaccine (mRNA-1893) Preclinical Data
Moderna will also present a preclinical study of its
investigational Zika vaccine (mRNA-1893) at IDWeek. The study shows
that intramuscular administration of mRNA-1893 induced a robust
neutralizing antibody response and provided complete protection
against transmission of the virus during pregnancy in mice. These
data have also been published in The Journal of Infectious
Diseases.
“There is a great need to prevent Zika around the world, and we
are committed to developing an effective vaccine designed to
prevent the spread of this infection, especially in women during
pregnancy,” said Zaks. “We look forward to sharing Phase 1 data
when available and continuing our work to improve public health
through the development of mRNA vaccines.”
Moderna’s investigational Zika vaccine (mRNA-1893), currently in
a Phase 1 study, was recently granted FDA Fast Track Designation.
More information about the study is available on
clinicaltrials.gov.
Zika virus has rapidly emerged in recent years as a pandemic
with potential long-term public health implications. Zika is
primarily transmitted by mosquitos, but can also be transmitted
sexually. Children born to mothers infected with Zika can develop
microcephaly, a severe disease characterized by small, not fully
developed heads and severe disabilities. In adults, outbreaks in
Latin American and Caribbean countries have been associated with
Guillain-Barré syndrome, a rare but serious autoimmune disorder in
which the immune system attacks part of the nervous system. There
is no approved vaccine for Zika.
About Moderna’s Development Candidates
mRNA-1653
mRNA-1653 is a single vaccine designed to protect against both
human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3),
two viruses that cause respiratory infections. It consists of two
distinct mRNA sequences encoding the membrane fusion (F) proteins
of hMPV and PIV3 formulated in Moderna’s proprietary lipid
nanoparticle (LNP) technology. mRNA-1653 is wholly owned by
Moderna.
mRNA-1893
mRNA-1893 contains an mRNA sequence encoding for the structural
proteins of Zika virus, designed to cause cells to secrete
virus-like particles, mimicking the response of the cell after
natural infection. mRNA-1893 is currently in a Phase 1 study
evaluating safety and immunogenicity in healthy volunteers and was
recently granted FDA Fast Track Designation. mRNA-1893 is wholly
owned by Moderna.
mRNA-1893 development is funded in whole or in part with Federal
funds from the U.S. Department of Health and Human Services (HHS);
the Office of the Assistant Secretary for Preparedness and
Response; and the Biomedical Advanced Research and Development
Authority (BARDA), under Contract No. HHSO100201600029C.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the Company’s prophylactic vaccines
modality to prevent or control infectious diseases. This modality
now includes eight development candidates, all of which are
vaccines against viruses. The potential advantages of an mRNA
approach to prophylactic vaccines include the ability to mimic
natural infection to stimulate a more potent immune response,
combining 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.
Four of the programs within this modality are aimed at
preventing respiratory illnesses and include respiratory syncytial
virus (RSV) vaccine (mRNA-1777 and mRNA-1172 or V172 with Merck),
human metapneumovirus and parainfluenza virus type 3 (hMPV+PIV3)
vaccine (mRNA-1653), influenza H10N8 vaccine (mRNA-1440) and
influenza H7N9 vaccine (mRNA-1851).
Other mRNA vaccine candidates include cytomegalovirus (CMV)
vaccine (mRNA-1647), Zika vaccine (mRNA-1893) with the Biomedical
Advanced Research and Development Authority (BARDA) and chikungunya
vaccine (mRNA-1388) with the Defense Advanced Research Projects
Agency (DARPA).
To date, Moderna has demonstrated positive Phase 1 data readouts
for six prophylactic vaccines (H10N8, H7N9, RSV [mRNA-1777],
chikungunya virus, hMPV+PIV3 and CMV).
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 have a therapeutic or preventive
benefit with 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 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, 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 four years. To learn more, visit
www.modernatx.com.
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 design, safety profile, tolerability and future
expectations regarding mRNA-1653 and mRNA-1893, including data from
the ongoing Phase 1 study of mRNA-1893 evaluating safety and
immunogenicity in healthy volunteers; Moderna’s plans to advance
mRNA-1653 into a Phase 1b study; the potential path forward to
evaluate protection against both hMPV and PIV3 in a single Phase 3
study; and Moderna’s commitment to developing an effective Zika
vaccine designed to prevent the spread of Zika infection and to
improve public health through the development of mRNA vaccines. 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 the interim results for mRNA-1653 will be predictive of the
final results for the ongoing study or any future clinical studies;
whether mRNA-1653 will be unsafe or intolerable during further
clinical studies, particularly studies involving pediatric
subjects; the fact that 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
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 www.sec.gov. Except as required by law, Moderna
disclaims any intention or responsibility for updating or revising
any forward-looking statements 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/20191002005234/en/
Media: Colleen Hussey Senior Manager, Corporate
Communications 203-470-5620 Colleen.Hussey@modernatx.com
Dan Budwick 1AB 973-271-6085 dan@1abmedia.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
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