Study conducted by Meiji Seika Pharma in
Japan
- Data follow approval of the world’s first Self-Amplifying
messenger RNA (sa-mRNA) COVID-19 Vaccine for Adults by Japan
Ministry of Health, Labor and Welfare
- The randomized, double-blind, active-controlled study,
conducted at 11 sites in Japan, was designed to compare the
immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154
with Comirnaty®
- Phase 3 Study published in The Lancet Infectious Diseases
Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and
Arcturus Therapeutics (Nasdaq: ARCT) today announced the
publication in Lancet Infectious Diseases of a Phase 3 study
showing that a booster dose of ARCT-154, a novel, self-amplifying
messenger RNA (sa-mRNA) vaccine, elicited a numerically higher
immune response (meeting the non-inferiority criteria) against the
original Wuhan-Hu-1 virus strain, and a superior immune response
against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a
booster dose of the conventional mRNA vaccine Comirnaty®. ARCT-154
results were achieved with one sixth the dose of Comirnaty® (5 μg
vs 30 μg).
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The study included healthy adults initially immunized with two
doses of an mRNA vaccine (Comirnaty® or Spikevax™); and then a
third dose of Comirnaty® at least three months prior to the booster
dose of either ARCT-154 or Comirnaty® in the study. Both vaccines
were well-tolerated, with no causally associated severe or serious
adverse events. The study was conducted in partnership with Meiji
Seika Pharma, a global health company based in Japan.
“The initial head-to-head results of the ARCT-154 study are
exciting as they show that our sa-mRNA vaccine platform has the
potential to produce immunogenicity against COVID-19 in previously
vaccinated patients that is as good or better—and at a much lower
dose—than first generation mRNA vaccines,” said Jonathan Edelman,
M.D., Senior Vice President, Vaccines Innovation Unit, CSL. “These
results move CSL one step closer to delivering on our promise to
develop and provide differentiated innovations that help protect
the public against the ongoing burden of COVID-19. We look forward
to sharing additional data from CSL’s sa-mRNA programs as we
continue to advance this exciting technology.”
“These important study findings mark another major achievement
in the development of our innovative sa-mRNA vaccine platform and a
significant moment for Arcturus and CSL,” said Pad Chivukula,
Ph.D., Chief Scientific Officer of Arcturus Therapeutics. “This
study represents the first phase of CSL and Arcturus’ plans to
launch this innovative vaccine platform globally.”
The phase 3 study results with ARCT-154 were used to support the
approval of ARCT-154 for primary immunization and as a booster dose
in Japan in November of this year.
The ARCT-154 study is ongoing and will continue to collect
safety data and assess durability of the immune response in
participants at 3-, 6- and 12-months post-vaccination.
Study design and results
The randomized, double-blind, active-controlled study, conducted
at 11 sites in Japan, was designed to compare the immunogenicity
and tolerability of the sa-mRNA vaccine ARCT-154 with authorized
mRNA COVID-19 vaccine Comirnaty.® Investigators compared immune
responses to ARCT-154 and Comirnaty® booster doses in healthy
Japanese adults 18 years of age or older initially immunized with
two doses of mRNA COVID-19 vaccine (Comirnaty® or Spikevax®) and
then a third dose of Comirnaty® at least three months prior to
receiving a booster dose of one of the study vaccines. Neutralizing
antibodies were measured before and 28 days after booster
vaccination. The primary objective was to demonstrate immunological
non-inferiority of ARCT-154 to Comirnaty®, as measured by
neutralizing antibodies against Wuhan-Hu-1 SARS-CoV-2. Primary
endpoints include geometric mean titer (GMT) ratios and
seroresponse rates (SRR) differences of neutralizing antibodies.
Key secondary objectives included the assessment of immunological
non-inferiority and superiority against the Omicron BA.4/5
subvariant and vaccine tolerability assessed using
participant-completed electronic diaries.
Between December 13, 2022, and February 25, 2023, 828
participants were enrolled and randomized 1:1 to receive ARCT-154
(n = 420) or Comirnaty® (n = 408) booster doses. Four weeks after
boosting, ARCT-154 induced higher Wuhan-Hu-1 neutralizing
antibodies GMTs than Comirnaty® (5641 [95% CI: 4321-7363] vs. 3934
[2993, 5169], respectively), a GMT ratio of 1·43 (95% CI:
1·26–1·63), with respective SRR of 65.2 (60.2–69.9 ) vs. 51.6%
(46·4 – 56·8), a difference of 13.6 (95% CI: 6.8 – 20.5), meeting
the pre-established non-inferiority criteria. Respective
anti-Omicron BA.4/5 GMTs were 2551 (1687–3859) and 1958
(1281–2993), a GMT ratio of 1·30 (95% CI: 1·07–1·58), with SRR of
69.97 (65.0–74.1) vs. 58.0% (52.8–63.1), meeting the superiority
criteria for ARCT-154 over Comirnaty®.
The booster doses of ARCT-154 and Comirnaty® were equally
well-tolerated in this adult population, with no causally
associated severe or serious adverse events; 95% and 97% of
ARCT-154 and Comirnaty® vaccinees respectively reported local
reactions and 66% and 63% had solicited systemic adverse events.
These were mainly mild, occurring and resolving within 3–4 days of
vaccination.
About sa-mRNA
In contrast to standard messenger RNA vaccine technology,
self-amplifying messenger RNA (sa-mRNA) vaccine technology helps
protect against infectious diseases by not only instructing cells
in the body to make a specific protein, but also to make copies of
these instructions in the cell. The produced protein antigen
stimulates the immune response and leaves a blueprint to recognize
and fight future infection. Because of the self-amplifying element
of the vaccine, more protein is produced compared to an equivalent
amount of standard mRNA, allowing for lower doses of sa-mRNA to be
used. sa-mRNA also has the potential to prompt a potent and durable
cellular immune response in addition to producing effective
antibodies against the targeted virus.
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 (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.
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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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