Published in the journal Vaccine, data show
vaccines targeting the H10N8 and H7N9 influenza viruses to be
highly immunogenic and well-tolerated in healthy adults
Results are from Moderna’s first human studies
of mRNA vaccines; demonstrates a new technological approach to flu
vaccine development and production
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 the publication of results from two
Phase 1 clinical studies showing that mRNA vaccines against H10N8
and H7N9 influenza viruses were well-tolerated and elicited robust
immune responses. The results support the potential of mRNA-based
vaccines to quickly and effectively address pandemic influenza
strains.
Published in the scientific journal Vaccine, the findings
include results from two randomized, placebo-controlled,
double-blind Phase 1 studies. Both studies met their primary safety
and secondary immunogenicity endpoints, and there were no
vaccine-related serious adverse events (AEs) reported. In both
studies, injection site pain was the most common solicited local
AE.
Both H10N8 and H7N9 influenza infections have demonstrated high
fatality rates, however neither have an approved vaccine.
“Both seasonal and pandemic influenzas are serious public health
problems, and there is a clear need for effective vaccines that can
be quickly developed and deployed. Production of current flu
vaccines takes significant time and requires virus or antigen
production in cell-culture or eggs and in dedicated facilities,”
said Mike Watson, senior vice president of vaccine partnerships and
health impact at Moderna and a study co-author. “These Phase 1 data
highlight the potential of Moderna’s mRNA platform to demonstrate
similar or better immunogenicity than existing vaccines, which can
be rapidly produced in a multi-use facility.”
H10N8 Study Design and Results
In the H10N8 study, 201 healthy volunteers aged 18 to 64 years
received two doses of vaccine or placebo three weeks apart,
intramuscularly (IM) at dose levels from 25 μg to 400 μg, or
intradermally (ID) at dose levels of 25 μg or 50 μg. The 100 μg IM
dose induced seroprotective immunity of hemagglutination inhibition
(HAI) ≥ 1:40 in 100 percent of participants and microneutralization
(MN) titers ≥ 1:20 in 87 percent of participants. The 25 μg ID dose
induced HAI titers ≥ 1:40 in 64.7 percent of participants compared
to 34.5 percent of participants receiving the IM dose. HAI titers
of 1:40 and MN titers of 1:20 are expected to be protective in
seasonal flu vaccines.
H7N9 Study Design and Results
In the H7N9 study, 156 healthy volunteers aged 18 to 49 years
received two doses of vaccine or placebo three weeks apart (IM) at
dose levels of 10 μg, 25 μg and 50 μg. A small subgroup also
received two doses of 25 μg or 50 μg IM six months apart. IM doses
of 10 μg, 25 μg and 50 μg achieved HAI titers ≥ 1:40 in 36 percent,
96.3 percent and 89.7 percent of participants, respectively. MN
titers ≥ 1:20 were achieved by 100 percent in the 10 μg and 25 μg
groups and by 96.6 percent in the 50 μg group.
Future development of Moderna’s pandemic influenza program is
contingent on government or other grant funding.
A link to the publication, mRNA Vaccines Against H10N8 and H7N9
Influenza Viruses of Pandemic Potential are Immunogenic and Well
Tolerated in Healthy Adults in Phase 1 Randomized Clinical Trials,
can be found here.
This is the third peer-reviewed publication of human data using
Moderna mRNA technology. In the past three years, Moderna and
collaborators have published more than 25 peer-reviewed papers,
with 12 in the last year alone.
About Moderna’s Prophylactic Vaccines Modality
Moderna has 21 mRNA development candidates in its pipeline,
with 11 programs now in the clinic. These investigational medicines
are grouped together into six modalities based on similar mRNA
technologies, delivery technologies and manufacturing processes.
Typically, programs within a modality will also share similar
pharmacology profiles, including the desired dose response,
expected dosing regimen, target tissue for protein expression,
safety and tolerability goals, as well as their pharmaceutical
properties.
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. Some of these programs are designed for
commercial use and others for global public health. The goal of any
vaccine is to safely pre-expose the immune system to a small
quantity of a protein from a pathogen, called an antigen, so that
the immune system is prepared to fight the pathogen if exposed in
the future and prevent infection or disease.
Moderna currently has four development candidates for potential
commercial uses in this modality, including: respiratory syncytial
virus (RSV) vaccine (mRNA-1777 and mRNA-1172 with Merck),
cytomegalovirus (CMV) vaccine (mRNA-1647) and human metapneumovirus
and parainfluenza virus type 3 (hMPV+PIV3) vaccine (mRNA-1653).
Four development candidates in this modality are being explored for
potential global health uses including: influenza H10N8 vaccine
(mRNA-1440), influenza H7N9 vaccine (mRNA-1851), 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).
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 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, 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.
About Vaccine
Vaccine is the pre-eminent journal for those interested in
vaccines and vaccination. It is the official journal of The Edward
Jenner Society and The Japanese Society for Vaccinology and is
published by Elsevier, www.elsevier.com/locate/vaccine. Copies of this paper are available to
credentialed journalists upon request; please contact Elsevier's
Newsroom at newsroom@elsevier.com or +31 20 485 2719.
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 immunogenicity, tolerability, and future
expectations regarding mRNA-1440 and mRNA-1851; the potential of
mRNA-based vaccines to quickly and effectively address pandemic
influenza strains; the potential of Moderna’s mRNA platform to
demonstrate similar or better immunogenicity than existing vaccines
that can be rapidly produced; and Moderna’s mRNA development
candidates’ ability to have a therapeutic or preventive benefit and
their potential to address a broad spectrum of diseases. 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
Phase 1 results for mRNA-1440 and mRNA-1851 will be predictive of
any future clinical studies; whether mRNA-1440 and mRNA-1851
will be unsafe or intolerable during future clinical studies;
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 at 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190510005216/en/
Moderna Contacts:Investors:Lavina TalukdarHead of
Investor Relations617-209-5834lavina.talukdar@modernatx.comMedia:Jason
GlashowHead of Corporate
Communications617-674-5648Jason.glashow@modernatx.com
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