Exclusive Partner in Japan, Meiji Seika
Pharma advances regulatory approval
- This historic approval of the world's first Self-Amplifying
messenger RNA (sa-mRNA) COVID-19 Vaccine underscores CSL's promise
to develop and deliver innovations when there is a public health
need
- First marketing approval milestone for CSL and Arcturus
Therapeutics since closing the Global Collaboration and Licensing
agreement in 2022
- With the approval of ARCT-154, CSL now offers an even more
comprehensive portfolio of innovative vaccines that combat
respiratory viral diseases.
KING OF
PRUSSIA, Pa. and SAN
DIEGO, Nov. 27, 2023 /PRNewswire/ -- Global
biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus
Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare
(MHLW) granted approval for ARCT-154, a self-amplifying mRNA
(sa-mRNA) COVID-19 vaccine for initial vaccination and booster for
adults 18 years and older.
Historic approval of the world's first
Self-Amplifying messenger RNA (sa-mRNA) COVID-19
Vaccine
"Self-amplifying mRNA technology has the potential to be an
enduring vaccine option," said Nobel laureate Dr. Drew Weissman, "I look forward to seeing this
next generation mRNA technology protect many from COVID-19 and
possibly other harmful infectious diseases."
"Today's approval marks a historic and exciting milestone as the
first sa-mRNA vaccine in the world to be registered, and supports
CSL's promise to protect global public health," said Jonathan Edelman, M.D., Senior Vice President,
Vaccines Innovation Unit, CSL. "We are committed to working with
health authorities around the world to ensure this important
vaccine technology will be available to people at risk for
COVID-19."
The approval is based on positive clinical data from several
ARCT-154 studies, including an ongoing 16,000 subject efficacy
study performed in Vietnam as
well as a Phase 3 COVID-19 booster trial, which achieved higher
immunogenicity results and a favorable safety profile compared to a
standard mRNA COVID-19 vaccine comparator. Initial study
results have been published in MedRxiv and are expected
to be published in a peer-reviewed journal by the end of the
year.
"We are proud of the role that Arcturus has played in this
collaboration to develop and validate the first approved sa-mRNA
product in the world," said Joseph
Payne, Chief Executive Officer of Arcturus Therapeutics.
"This approval for the sa-mRNA COVID-19 vaccine is a major
achievement, and we are excited to embark on future endeavors that
utilize our innovative sa-mRNA vaccine platform alongside our
global exclusive partner, CSL."
CSL's vaccine business, CSL Seqirus, one of the largest
influenza vaccine providers in the world, partnered exclusively
with Meiji Seika Pharma for distribution of the sa-mRNA COVID
vaccine, ARCT 154, in Japan.
"Our expertise in seasonal and pandemic influenza positions us
well to help the global community reduce the burden of COVID-19 and
we look forward to playing a key role in helping protect the people
of Japan," said Stephen Marlow, Senior Vice President and
General Manager of CSL Seqirus.
About sa-mRNA
Messenger RNA (mRNA) vaccine technology
protects against infectious diseases by instructing cells in the
body to make a specific protein, stimulating the immune response,
and leaving a blueprint to recognize and fight future infection.
However, sa-mRNA makes copies of the mRNA which generates the
production of more protein compared to an equivalent amount of mRNA
in a vaccine. The technology has the potential to create more
potent cellular immune responses and increase duration of
protection, while using considerably lower doses of mRNA.
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 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 (sa-mRNA) and
(iii) mRNA drug substance along with drug product manufacturing
expertise. The Company 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 deficiency and cystic fibrosis, 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 (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.
Media Contacts:
CSL Media Contacts
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
Asia
Pacific:
Hamish
Walsh
+61 422 424 338
hamish.walsh@seqirus.com
Arcturus Media Contact:
Neda
Safarzadeh
VP, Head of IR/PR/Marketing
IR@arcturusrx.com
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SOURCE CSL