- KOSTAIVE represents a significant advancement in vaccine
technology, demonstrating superior immunogenicity and antibody
persistence for up to 12 months post-vaccination compared to
conventional mRNA COVID-19 vaccines in clinical trials
WALTHAM,
Mass. and SAN DIEGO,
Feb. 14,
2025 /PRNewswire/ -- Global biotechnology leader CSL
(ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics
(Nasdaq: ARCT) today announced that the European Commission
has granted marketing authorization for KOSTAIVE ®
(ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for
individuals 18 years and older. KOSTAIVE is the first sa-mRNA
COVID-19 vaccine to receive approval from the European Commission
(EC). KOSTAIVE is currently marketed in Japan against COVID-19.
The European Commission approval follows a positive opinion
adopted by the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) on December 12, 2024. The centralized marketing
authorization of KOSTAIVE is valid in all EU member states and in
the EEA countries.
"The European Commission's approval marks a significant
milestone in our ongoing development program for KOSTAIVE," said
Jonathan Edelman, MD, Senior Vice
President of the Vaccines Innovation Unit, CSL. "We are actively
working to optimize KOSTAIVE's formulation to better meet the needs
of healthcare professionals and their patients. As COVID-19 remains
an unpredictable global threat, CSL is dedicated to completing
these technical enhancements and making this innovative vaccine
available in Europe as soon as
possible."
The approval is based on positive clinical data from several
studies, including an integrated phase 1/2/3 study
demonstrating KOSTAIVE's efficacy and tolerability, and Phase 3
COVID-19 booster trials, which achieved higher immunogenicity
results compared to a conventional mRNA COVID-19 vaccine
comparator. A follow-up analysis evaluating a booster dose of
KOSTAIVE also showed that the vaccine elicited
superior immunogenicity and antibody persistence for up
to 12 months post-vaccination against multiple SARS-CoV-2 strains
in both younger and older adult age groups versus the same mRNA
comparator.
"KOSTAIVE and sa-mRNA technology signify a major advancement in
vaccine innovation, providing the potential for broader and more
enduring protection," said Joseph
Payne, CEO of Arcturus. "This approval highlights the
clinical promise of KOSTAIVE and its ability to protect against the
ever-changing COVID-19 virus."
About sa-mRNA
mRNA vaccines help protect against
infectious diseases by providing a blueprint for cells in the body
to make a protein to help our immune systems recognize and fight
the disease. Unlike standard mRNA vaccines, self-amplifying mRNA
vaccines instruct the body to make more mRNA and protein to boost
the immune response.
About CSL
CSL (ASX: CSL; USOTC: CSLLY) is a global
biotechnology company with a dynamic portfolio of lifesaving
medicines, including those that treat haemophilia and immune
deficiencies, vaccines to prevent influenza, and therapies in iron
deficiency and nephrology. Since our start in 1916, we have been
driven by our promise to save lives using the latest technologies.
Today, CSL – including our three businesses: CSL Behring, CSL
Seqirus and CSL Vifor – provides lifesaving products to patients in
more than 100 countries and employs 32,000 people. Our unique
combination of commercial strength, R&D focus and operational
excellence enables us to identify, develop and deliver innovations
so our patients can live life to the fullest. For inspiring stories
about the promise of biotechnology,
visit CSLBehring.com/Vita and follow us
on Twitter.com/CSL.
For more information about CSL, visit www.CSL.com.
About Arcturus
Founded in 2013 and based in San
Diego, California, Arcturus Therapeutics Holdings
Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and
vaccines company with enabling technologies: (i) LUNAR®
lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and
(iii) mRNA drug substance along with drug product manufacturing
expertise. Arcturus developed KOSTAIVE®, the first self-amplifying
messenger RNA (sa-mRNA) COVID vaccine in the world to be approved.
Arcturus has an ongoing global collaboration for innovative mRNA
vaccines with CSL Seqirus, and a joint venture
in Japan, ARCALIS, focused on the manufacture of mRNA
vaccines and therapeutics. Arcturus' pipeline includes RNA
therapeutic candidates to potentially treat ornithine
transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along
with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19)
and influenza. Arcturus' versatile RNA therapeutics platforms can
be applied toward multiple types of nucleic acid medicines
including messenger RNA, small interfering RNA, circular RNA,
antisense RNA, self-amplifying RNA, DNA, and gene editing
therapeutics. Arcturus' technologies are covered by its extensive
patent portfolio (over 400 patents and patent applications in
the U.S., Europe, Japan, China, and other
countries). For more information, visit www.ArcturusRx.com. In
addition, please connect with us
on Twitter and LinkedIn.
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, future operations, the likelihood of success (including
safety, efficacy and commercialization) of KOSTAIVE, the likelihood
that clinical results received to date will be predictive of future
clinical results of protection against changing virus variants, the
likelihood of optimizing KOSTAIVE's formulation and completing
technical enhancements, 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.
CSL Media Contacts:
Sue
Thorn, CSL
Mobile : +1 617-799-3151
Email: Sue.Thorn@cslbehring.com
Em Dekonor, CSL Seqirus
Mobile: +44 (0)7920500496
Email: Emmanuella.Dekonor@seqirus.com
In Australia:
Jimmy Baker, CSL
Mobile: +61 450 909 211
Email: Jimmy.Baker@csl.com.au
Investor Inquiries:
Chris Cooper, CSL
Mobile: +61 455 022 740
Email: Chris.Cooper@csl.com.au
Arcturus Media Contact:
Public Relations & Investor Relations
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com
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