- Data follow the approval of the world's first
self-amplifying (sa-mRNA) COVID-19 vaccine for adults in
Japan.
- These results add to recently published data on ARCT-154
demonstrating superior immunogenicity to Omicron BA 4/5 compared to
conventional mRNA COVID-19 vaccine booster and follow-up data
demonstrating longer duration of immunity compared to traditional
COVID-19 mRNA vaccine booster.
KING OF
PRUSSIA, Pa. and SAN
DIEGO, May 20, 2024 /PRNewswire/ -- Global
biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus
Therapeutics (Nasdaq: ARCT) today announce Nature
Communications has published results from an integrated phase
1/2/3a/3b study evaluating the
safety, immunogenicity, and efficacy of ARCT, 154, a novel
self-amplifying (sa-mRNA) COVID-19 vaccine and the world's first
approved sa-mRNA COVID-19 vaccine.
The results demonstrate that two 5 μg doses of ARCT-154, sa-mRNA
vaccine, were well-tolerated, immunogenic and provided significant
protection against multiple strains of COVID-19. The efficacy of
ARCT-154 against severe COVID-19 was 100 percent in healthy persons
aged 18-59 and more than 90 percent in persons at risk of severe
consequences of the disease due to co-morbidities or older age.
"The results published in Nature
Communications demonstrate the efficacy and tolerability
of ARCT-154 and add to a growing body of evidence that our sa-mRNA
vaccine has the potential to provide significant protection against
the pervasive virus, reinforcing our promise to protect public
health," said Jon Edelman, M.D.,
Senior Vice President, Vaccines Innovation Unit, CSL.
"We are thrilled that the results of the ARCT-154 study have
been published in the highly respected journal Nature
Communications," said Pad Chivukula, Ph.D., Chief Scientific
Officer of Arcturus Therapeutics. "These data and the approval in
Japan highlight the strength of
our and CSL's commitment to delivering innovative technology that
protects the public from COVID-19."
The Nature Communications article titled, "Safety and
immunogenicity and efficacy of the self-amplifying mRNA ARCT-154
COVID-19; pooled phase 1, 2, 3a, and 3b randomized, controlled trials" was published
online.
About the study
During the observer-blind, randomized,
controlled phase 1, 2, 3a and 3b
integrated study, adults ≥18 years old receive two 5 μg doses of
ARCT-154 or saline placebo 28 days apart. Phase 2/3a/3b participants were stratified by age (< 60
or ≥ 60 years of age) and by risk of severe COVID-19 prior to being
randomized 3:1 (phase 1/2/3a) or 1:1 (phase 3b) to vaccine or placebo groups. The primary
endpoints were vaccine efficacy up to 2 months after dose 2,
reactogenicity within up to 7 days of each dose, safety within up
to 28 days after each dose, and immunogenicity measured 28 days
after each dose From August 15 to January
12, 2023, 1,001 participants were randomized (748 ARCT-154
and 253 placebo) in the integrated phase 1/2/3a study, and 16,100
participants (8,056 ARCT-154 and 8,044 placebo) in the phase
3b study.
In the phase 1/2/3a studies, ARCT-154 was safe and well
tolerated. Most solicited adverse events were mild or moderate and
resolved quickly, and rates of related or severe unsolicited
adverse events were similar in the ARCT-154 and placebo groups. The
phase 3b study confirmed these
observations.
Four weeks after the second ARCT-154 dose in phase 3b, the neutralizing antibody seroconversion rate
was 94.1% (95% CI: 92•1–95•8). There were 640 confirmed,
protocol-defined COVID-19 cases, mainly of the Delta variant, that
were determined to be eligible for analysis, including 43 severe
cases and 10 deaths attributed to COVID-19. ARCT-154 absolute
efficacy was 56.6% (95% CI: 48.7– 63.3) against any COVID-19, 95•3%
(80.5–98.9) against severe COVID-19 and 86.5% (-7.4–98.3) against
death due to COVID-19. Efficacy against severe COVID-19 was 100% in
healthy 18-59-year-olds and 91.9% (37.9-98.9) in participants in
that age group with underlying co-morbidities, which put them at
risk for severe disease. In adults aged 60 years or older, efficacy
was 54.3% (28.2–70.9) against COVID-19 of any severity and 94.4%
(58.2–99.3) against severe COVID-19.
The study was co-funded by Vinbiocare Biotechnology Joint Stock
Company in Hanoi, Vietnam, and
Arcturus Therapeutics.
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. Unlike 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 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 (Kostaive®) 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 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.
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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