Tolerability: AZD8601 was well tolerated when
administered directly into the skin
Protein Expression: Demonstrated dose-dependent
protein translation
Protein Pharmacology: mRNA injected directly
into skin of patients showed evidence of increased blood flow
AZD8601 now in an ongoing Phase 2a study with
patients receiving epicardial injections of VEGF-A mRNA during
coronary artery bypass grafting surgery
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 a Phase 1a/b
study in Nature Communications showing the potential of mRNA
encoding for vascular endothelial growth factor A (VEGF-A) as a
regenerative therapeutic. This approach aims to stimulate the
growth of new blood vessels, also known as angiogenesis, to improve
blood flow in tissues where it is otherwise restricted.
The Phase 1a/b study, conducted with AstraZeneca, was a
randomized, double-blind, placebo-controlled study in Europe of men
with type 2 diabetes mellitus. The VEGF-A mRNA was delivered in a
saline solution and was administered by intradermal injection into
forearm skin in single ascending doses. The trial met its primary
objectives of describing safety and tolerability and secondary
objectives of protein production and changes in local blood flow
post injection.
“I believe this is an important milestone in the field of mRNA
therapeutics as it starts to address many questions regarding the
safety and delivery of mRNA to human tissues, the duration and
level of the protein that can be expressed and the ability of the
technology to have a physiologic, measurable function over a
prolonged period of time,” said Kenneth Chien, M.D., Ph.D., a
professor in the Department of Cell and Molecular Biology and the
Integrated Cardio Metabolic Center at the Karolinska Institute in
Stockholm, a Moderna scientific co-founder and co-author on the
paper. “Based on these early data, this approach may provide
benefit to patients where proper blood flow is compromised in areas
such as heart disease and diabetes as well as for other vascular
complications.”
The study showed VEGF-A protein post injection of AZD8601 was
increased above the pre-specified expected threshold, as measured
by skin microdialysis. At each sampling time, mean VEGFA protein
levels, across all mRNA-treated sites from patients across all
cohorts, were higher than that of placebo up to the 24-26 hour time
point in the study. The bioactivity of the VEGF-A protein post
injection of AZD8601 was also observed by an increase in blood flow
at injection sites up to seven days following a single injection,
as measured by laser doppler imaging. The only treatment-related
adverse events reported were mild injection-site reactions, and the
treatment was overall well tolerated.
“We are encouraged by these initial data as they support the
ability of AZD8601 to transiently produce pharmacologically active
amounts of VEGF-A protein, which may in the future regenerate blood
vessels for patients with ischemic cardiovascular disease,” said
Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “These
findings improve our understanding of the potential for Moderna’s
mRNA to produce therapeutic levels of protein and help patients
with a wide range of serious diseases.”
“Despite significant advances in treatment over the past 30
years, up to 45 percent of people with heart failure worldwide do
not survive past a year of being discharged from hospital,” said
Regina Fritsche Danielson, senior vice president and head of early
CVRM, R&D BioPharmaceuticals, AstraZeneca. “Based on these
results and others, we moved AZD8601 into a Phase 2a study to
investigate the safety and tolerability of the drug candidate
following epicardial injection in patients undergoing coronary
artery bypass grafting surgery. We are committed to continue to
assess the potential of AZD8601 in patients with heart
failure.”
A link to the publication, Intradermal Delivery of Modified mRNA
Encoding VEGF-A in Patients with Type 2 Diabetes (Gan LM, et. al.),
can be found on the Nature Communications website at
www.nature.com/ncomms/.
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 Moderna 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 potential of mRNA encoding for VEGF-A to benefit
patients where proper blood flow is compromised in areas such as
heart disease and diabetes as well as for other vascular
complications and its potential to regenerate blood vessels for
patients with ischemic cardiovascular disease; the ability of
Moderna’s mRNA to produce therapeutic levels of protein; and the
potential of mRNA encoding for VEGF-A to offer a therapeutic
approach in improving cardiac function. 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 category
of medicines such as mRNA, and therefore Moderna’s preclinical
programs or development candidates may be delayed, terminated, or
may never advance in the clinic; no mRNA drug has been approved in
this new potential category 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 category of medicines; and those described in
Moderna’s Prospectus filed with the U.S. Securities and Exchange
Commission (SEC) on December 7, 2018 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190220005139/en/
Moderna Contacts:Investors:Lorence KimChief
Financial Officer617-209-5849Lorence.kim@modernatx.com
Media:Jason GlashowHead, Corporate
Communications617-674-5648Jason.glashow@modernatx.com
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