Moderna Announces Positive Interim Phase 1 Data for First Combination Vaccine Against the Respiratory Viruses hMPV and PIV3

Interim data show vaccination with mRNA-1653 boosted serum
neutralization titers against hMPV and PIV3 at all dose levels tested
and was generally well tolerated

Company plans to advance mRNA-1653 into a Phase 1b study in
seropositive pediatric subjects

Conference call to be held at 5:00 p.m. ET today

CAMBRIDGE, Mass.–(BUSINESS WIRE)–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
topline data from the first planned interim analysis of safety and
immunogenicity from its Phase 1 study of mRNA-1653 in healthy adults.
mRNA-1653 is a wholly-owned program in Moderna’s prophylactic vaccine
modality.

mRNA-1653 is designed to protect against human metapneumovirus (hMPV)
and parainfluenza type 3 (PIV3), two viruses that cause respiratory
infections. It is a combination vaccine that consists of two
distinct mRNA sequences encoding the fusion (F) proteins of hMPV and
PIV3 formulated in Moderna’s proprietary lipid nanoparticle (LNP)
technology.

“There are no approved vaccines to prevent hMPV or PIV3 infections,
which are significant causes of severe respiratory diseases and
hospitalizations for infants and children,” said Tal Zaks, M.D., Ph.D.,
chief medical officer at Moderna. “Based on these positive interim Phase
1 data, we are excited to further advance mRNA-1653 into pediatrics as
the first combination vaccine to focus on both hMPV and PIV3.”

These Phase 1 interim data show that a single vaccination with mRNA-1653
boosted serum neutralization titers against hMPV and PIV3, and that the
magnitude of the boost was similar at all dose levels tested. Consistent
with prior exposure to hMPV and PIV3, all study participants had
neutralizing antibodies against both viruses at baseline. One month
after a single mRNA-1653 vaccination, the hMPV neutralization titers
were approximately six-fold baseline and PIV3 neutralization titers were
approximately three-fold baseline (based on geometric mean ratios). A
second mRNA-1653 vaccination one month after the first vaccination did
not further boost antibody titers, suggesting a single vaccination was
sufficient to achieve a plateau in neutralizing antibodies in this
pre-exposed population.

mRNA-1653 was found to be generally well tolerated. No serious adverse
events (SAEs), adverse events of special interest, or adverse events
leading to withdrawal were reported. Injection site pain was the most
commonly reported adverse event and the most common Grade 3 adverse
event.

Much of Moderna’s commercial vaccine development efforts are focused on
addressing major causes of respiratory infections, including hMPV+PIV3
and respiratory syncytial virus (RSV). These infections share many of
the same features, often causing upper and lower respiratory tract
illness, characterized by wheezing, bronchiolitis and pneumonia and are
associated with a substantial burden of hospitalizations and outpatient
visits among children throughout the first five years of life. There are
currently no approved vaccines for hMPV, PIV3 or RSV.

Conference Call

Moderna will host a conference call and webcast today at 5:00 p.m. ET to
discuss these interim data and the Company’s broader efforts to develop
respiratory vaccines. Participants are invited to listen by dialing
(866) 922-5184 (domestic) or (409) 937-8950 (international) and
providing conference ID 3580988 or join the live webcast by going to the “Events
and Presentations”
area on the Investors page of the Company’s
website, www.modernatx.com.
An archived webcast of the conference call can also be accessed through
the Company’s website and a replay of the call will be available there
for four weeks after the call.

About the Study

mRNA-1653-P101 is a Phase 1, first-in-human, randomized, observer-blind,
placebo-controlled, dose-ranging study in healthy adults. The trial’s
key objectives include evaluating the safety and tolerability,
reactogenicity and humoral immunogenicity of mRNA-1653, and selecting
the optimal dose and vaccination schedule for further clinical
development. This study is being conducted in the United States, and
enrolled 124 subjects across four dose levels of mRNA-1653 (25, 75, 150,
and 300 µg) and placebo. Subjects were randomized to a one-dose or
two-dose vaccination schedule, with the second vaccination of mRNA-1653
administered one month after the first vaccination.

About Moderna’s Prophylactic Vaccines Modality

Moderna has 21 mRNA development candidates in its pipeline, with 12
programs now in clinical development. 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
nine programs, all of which are vaccines against viruses. Some of these
programs are designed for commercial use and others for 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: RSV (mRNA-1777 with Merck),
cytomegalovirus (CMV) vaccine (mRNA-1647), hMPV+PIV3 vaccine (mRNA-1653)
and varicella zoster virus (VZV) vaccine (mRNA-1278 with Merck).

Five 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-1325
and mRNA-1893 with BARDA) and chikungunya vaccine (mRNA-1388 with DARPA).

About hMPV and PIV3

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 the 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.

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; the Company’s plans to advance mRNA-1653 into a Phase 1b
study; and the final and expected outcomes of Moderna’s other clinical
trials. 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 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.

Contacts

Moderna Contacts:
Investors:
Lorence Kim
Chief
Financial Officer
617-209-5849
[email protected]

Media:
Jason Glashow
Head, Corporate Communications
617-674-5648
[email protected]

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