Arcturus Announces $63.2 Million Award from the U.S. Government to Support Development of Self-amplifying mRNA Vaccine for Rapid Pandemic Influenza Response
31 Agosto 2022 - 3:00PM
Business Wire
Arcturus will expand its current influenza
vaccine program to include development of a pandemic influenza
vaccine based on its proprietary self-amplifying mRNA platform with
the support of the Biomedical Advanced Research and Development
Authority
$63.2 Million base award to fund development
from preclinical stage through Phase 1 over three-year period
A lower-dose, freeze-dried, pandemic influenza
vaccine candidate will use Arcturus’ STARR™ self-amplifying mRNA
vaccine platform technology which demonstrated favorable safety and
efficacy against SARS-CoV-2 infection combined with a stable cold
chain profile that may help support U.S. government pandemic
preparedness goals
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
Nasdaq: ARCT), a global, late-stage clinical messenger RNA
medicines company focused on the development of infectious disease
vaccines and significant opportunities within liver and respiratory
rare diseases, today announced that it has obtained an award for up
to $63.2 million from the Biomedical Advanced Research and
Development Authority (BARDA). The award provides $63.2 million
over three years to support preclinical, manufacturing, nonclinical
safety studies, along with development and regulatory support for
Arcturus’ self-amplifying mRNA vaccine platform technology for
rapid pandemic influenza response through Phase 1 clinical
studies.
“We are very pleased to have won this substantial award from the
BARDA and look forward to working with the U.S. government to
support the development of our proprietary self-amplifying mRNA
vaccine technology for rapid pandemic influenza response. Arcturus’
next generation mRNA platform has been administered to over 10,000
individuals globally demonstrating favorable safety, strong
immunogenicity, and protection against SARS-COV-2 infection,” said
Joseph Payne, President and CEO of Arcturus Therapeutics. “Our
lyophilized vaccines have the potential to provide safe and
effective protection against disease with the specific advantage of
rapid scale-up, lower doses, and easier transport and storage.
These are qualities that are essential to a rapid response against
pandemic influenza and are consistent with strategic objectives of
the U.S. government’s National Strategy for Pandemic
Influenza.”
This project has been supported in whole or in part with federal
funds from the Department of Health and Human Services, Office of
the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA), under Contract
Number: 75A50122C00007
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage
clinical mRNA medicines and vaccines company with enabling
technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA
Technology (samRNA) and (iii) mRNA drug substance along with drug
product manufacturing expertise. Arcturus’ diverse pipeline of RNA
therapeutic and vaccine candidates includes mRNA vaccine programs
for SARS-CoV-2 (COVID-19) and Influenza, and other programs to
potentially treat ornithine transcarbamylase (OTC) deficiency, and
cystic fibrosis, along with partnered programs including glycogen
storage disease type III, and hepatitis B virusArcturus’ versatile
RNA therapeutics platforms can be applied toward multiple types of
nucleic acid medicines including messenger RNA, small interfering
RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing
therapeutics. Arcturus’ technologies are covered by its extensive
patent portfolio (patents and patent applications issued in the
U.S., Europe, Japan, China and other countries). Arcturus’
commitment to the development of novel RNA therapeutics has led to
collaborations including, amongst others, Janssen Pharmaceuticals,
Inc., part of the Janssen Pharmaceutical Companies of Johnson &
Johnson, Ultragenyx Pharmaceutical, Inc., and the Cystic Fibrosis
Foundation. In addition, please connect with us on Twitter and
LinkedIn. For more information visit www.ArcturusRx.com.
Forward Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. Any statements, other than statements of historical
fact included in this press release, are forward-looking
statements, including those regarding strategy, the expectations
for or likelihood of success of any collaborations, the likelihood
of success of the Company’s development and related efforts for an
influenza vaccine candidate, the likelihood of the Company’s
lyophilized vaccines to provide safe and effective protection
against disease, the future activities under and fulfillment of the
Company’s contract with BARDA, the ability of the Company’s
influenza vaccine program to support U.S. government pandemic
preparedness goals, the likelihood that a patent will issue from
any patent application, and the impact of general business and
economic conditions. Arcturus may not actually achieve the plans,
carry out the intentions or meet the expectations or projections
disclosed in any forward-looking statements such as the foregoing
and you should not place undue reliance on such forward-looking
statements. These statements are only current predictions or
expectations, and are subject to known and unknown risks,
uncertainties, and other factors that may cause our or our
industry’s actual results, levels of activity, performance or
achievements to be materially different from those anticipated by
the forward-looking statements, including those discussed under the
heading "Risk Factors" in Arcturus’ most recent Annual Report on
Form 10-K, and in subsequent filings with, or submissions to, the
SEC, which are available on the SEC’s website at www.sec.gov.
Except as otherwise required by law, Arcturus disclaims any
intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether
as a result of new information, future events or circumstances or
otherwise.
Trademark Acknowledgements
The Arcturus logo and other trademarks of Arcturus appearing in
this announcement, including LUNAR® and STARR™, are the property of
Arcturus. All other trademarks, services marks, and trade names in
this announcement are the property of their respective owners.
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IR and Media Contacts Arcturus Therapeutics
IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
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