Study conducted by Meiji Seika Pharma
in Japan
- Short communication follows previously published data in The
Lancet Infectious Diseases demonstrating
Immunological Non-Inferiority to Wuhan Strain and
Superior Immunogenicity to Omicron BA.4/5 Variant Compared to
First-Generation mRNA Vaccine Booster
- New data demonstrates continuous advantage of sa-mRNA
over conventional mRNA vaccine in terms of duration of immune
response
- These results follow approval of the world's
first sa-mRNA COVID-19 vaccine for adults by Japan Ministry of
Health, Labor and Welfare in November
2023
KING OF
PRUSSIA, Pa. and SAN
DIEGO, Feb. 5, 2024 /PRNewswire/ -- Global
biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus
Therapeutics (Nasdaq: ARCT) today announced the results of
a follow-up analysis of a Phase 3 study evaluating a booster
dose of ARCT-154 , the world's first approved
self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared
to a conventional mRNA COVID-19 vaccine. ARCT-154 was administered
at one-sixth the dose of Comirnaty® (5 μg vs 30 μg,
respectively).
The new analysis at 6 months post-vaccination shows that
ARCT-154 induces a longer immune response as compared to Comirnaty
for both the original Wuhan strain
and Omicron BA.4/5 variant and an advantage in antibody
persistence.
"These results further support sa-mRNA's differentiating
attribute to provide prolonged protection against COVID-19 at lower
doses," said Jonathan Edelman, M.D.,
Senior Vice President, Vaccines Innovation Unit, CSL. "Protecting
the global public from viral respiratory diseases remains a top
priority for us, and we look forward to continuing to collect and
share data at the twelve-month post-booster mark."
"This data, coupled with the initial Phase 3 results and
approval in Japan late last year,
show that this innovative vaccine technology has the potential to
provide significant advancements over conventional mRNA vaccines
including prolonged protection at lower doses," said Pad Chivukula,
Ph.D., Chief Scientific Officer of Arcturus Therapeutics.
ARCT-154 Six-Month Data Report
This randomized,
double-blind, active-controlled study, conducted at 11 sites in
Japan assessed the immunogenicity
of ARCT-154 and Comirnaty® at one, three- and
six-months post-booster. Participants who displayed seropositivity
for SARS-CoV-2 N-protein on Days 1, 29, 91 or 181 were considered
indicative of recent COVID-19 infection and therefore, were
progressively excluded from the analysis, leaving 332 and 313
participants in ARCT-154 and Comirnaty® groups,
respectively, eligible for inclusion at the six-month
immunogenicity evaluation.
At baseline, participants in both groups had similar geometric
mean titers (GMTs) surrogate virus neutralizing antibodies against
Wuhan-Hu-1 strain (GMT ratio was 0.94 (95% CI 0.78-1.13)).
One-month post-booster, the ARCT-154 group displayed a higher
immune response with GMT of 5390 (95% CI 4899-5931, n = 378)
compared to Comirnaty® group with GMT of 3738 (95%
CI 3442-4060, n = 367), and a GMT ratio of 1.44 (95% CI
1.27–1.64).
Three months post-booster GMTs were 5928 (95% CI 5414–6491, n =
369) and 2899 (2648–3175, n = 356), with a higher GMT ratio of 2•04
(1•80–2•32). Day 91 titers were equal to or greater than Day 29
titers in 205 of 369 (55•6% [95% CI 50•3–60•7]) ARCT-154
recipients, but in only 108 of 356 (30•3% [25•6–35•4])
Comirnaty® recipients. Due to different rates of
antibody waning, by Day 181 GMTs were 4119 (95% CI 3723–4557, n =
332) and 1861 (1667–2078, n= 313) in ARCT-154 and
Comirnaty® groups, respectively, maintaining a GMT
ratio of 2•21 (1•91–2•57) between vaccine groups. GMTs against
Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than
those observed 28 days after the
Comirnaty® booster.
The same pattern of superior immunogenicity and slower decline
in Omicron BA.4/5 neutralizing antibodies was observed: GMTs were
comparable at baseline (GMT ratio of 0.94 (95% CI 0.71-1.26), and
increased to 2125 (95% CI 1841–2453) vs. 1624 (1418–1858) at Day 29
after ARCT-154 and Comirnaty®, then waned to 1892
(1646–2175) and 888 (764–1031), respectively, at Day 91. Between
Days 29 and 91 titers were stable or increased in 128 of 369 (34•7%
[95% CI 29•8–39•8]) ARCT-154 recipients, compared with 36 of 356
(10.1% [7•2–13•7]) in the Comirnaty® group. The
difference in neutralizing activity against Omicron BA.4/5 was
maintained to Day 181 when GMTs were 1119 (95% CI 960–1305) and 495
(413–595), with a GMT ratio of 2•26 (1•78–2•86) in favor of
ARCT-154.
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. Different from 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 hemophilia 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. Arcturus
developed 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 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 (over 400 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 Meiji Seika Pharma Co., Ltd.
Meiji Seika Pharma,
since it launched penicillin in 1946, has been providing
efficacious and high-quality pharmaceutical products such as
therapeutics and vaccines for infectious diseases, therapeutics for
central nervous system diseases as well as generic drugs in
response to various medical needs. As a leading company in the
field of infectious diseases, we are strengthening our platform for
infection control and prevention with vaccines and
antimicrobial agents.
Arcturus 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
plans to collect and share additional data and analyses and the
potential of the sa-mRNA technology to provide advancements over
conventional mRNA vaccines. 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, 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.
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
Jimmy Baker
Mobile: +61 450 909 211
Email: Jimmy.Baker@csl.com.au
Arcturus Media Contact:
Neda
Safarzadeh
VP, Head of IR/PR/Marketing
Email: IR@arcturusrx.com
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