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
KING OF
PRUSSIA, Pa. and SAN
DIEGO, Dec. 21, 2023 /PRNewswire/ -- 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).
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.
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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SOURCE CSL