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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240205318668/en/
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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