EMA application supported by Phase 3 primary
vaccination study demonstrating primary efficacy endpoint was
met
An additional Phase 3 booster study
demonstrating non-inferiority of immune response compared to
Comirnaty® and superiority of ARCT-154 in neutralizing antibody
response against SARS-CoV-2 Omicron BA.4/5 variant was shown as a
key secondary endpoint
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 opportunities within liver and respiratory rare diseases, and
CSL (ASX:CSL), and its vaccine business, CSL Seqirus, one of the
largest influenza vaccine providers in the world, announced today
that the European Medicines Agency (EMA) has validated the
marketing authorization application (MAA) for ARCT-154, a next
generation mRNA vaccine, for active immunization to prevent
COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and
older. The companies (Arcturus and CSL Seqirus) anticipate an
approval decision by the European Commission in 2024.
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The EMA submission is based on successful Phase 3 clinical
results of ARCT-154 against the ancestral D614G variant as a
primary series and booster. In an analysis of 6-month data from the
pivotal Phase 3 study, the primary efficacy endpoint was met and
ARCT-154 as a primary series resulted in 56.6% efficacy for
prevention of symptomatic COVID-19 overall, and 95.3% efficacy for
prevention of severe COVID-19 including COVID-19 related deaths.
The study was conducted when Delta variant was dominant in Vietnam.
The booster data result was previously announced by CSL Seqirus’
partner, Meiji Seika Pharma, indicating that the primary endpoint
was achieved in a Phase 3 booster vaccine study by demonstrating
non-inferiority of immune response against SARS-CoV-2 ancestral
strain compared to Comirnaty®. Superiority of ARCT-154 in
neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5
variant was a key secondary endpoint.
“EMA acceptance of the marketing application for ARCT-154
represents another major achievement in the development of this
innovative mRNA vaccine platform. This is also an important
milestone for Arcturus and our global exclusive partner, CSL
Seqirus, as we work towards achieving approval in Europe,” said
Joseph Payne, President & CEO of Arcturus Therapeutics.
“ARCT-154 is expected to be efficiently updated as new variants of
concern arise and has the potential to be a longer lasting vaccine
against the pervasive and ever-changing COVID virus.”
“This pivotal regulatory milestone brings CSL one step closer to
bringing innovative mRNA vaccines to Europe,” said Emmanuelle
Lecomte Brisset, Head of Global Regulatory Affairs at CSL. “We look
forward to working with regulatory authorities to continue to
advance how we protect public health.”
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. The Company has an ongoing
exclusive global collaborative partnership for innovative mRNA
vaccines with CSL Seqirus. The Company also has a joint venture
with the Japanese CMO, ARCALIS. Arcturus’ pipeline includes RNA
therapeutic candidates to potentially treat ornithine
transcarbamylase deficiency and cystic fibrosis, along with its
partnered innovative mRNA vaccine programs for SARS-CoV-2
(COVID-19), influenza, pandemic preparedness and a range of other
respiratory pathogens. 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 (patents and patent applications issued 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.
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.
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 of ARCT-154 and the partnered COVID-19
program, the timing for an approval decision by the European
Commission for ARCT-154, the likelihood that any clinical data will
be predictive of future clinical results, the likelihood that the
interim study results of the ARCT-154 Phase 3 booster vaccine study
will be predictive of, or consistent with, the complete study
results, the potential for ARCT-154 to be a longer lasting vaccine,
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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Arcturus Therapeutics IR and Media Contacts Neda
Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682
IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
CSL Media Contacts U.S. Sue Thorn Mobile: 617 799
3151 Email: sue.thorn@cslbehring.com
Australia: Kim O'Donohue Mobile: 0449 884 603 Email:
kim.odonohue@csl.com.au
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