- 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.
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,
immunogenicity and efficacy of the self-amplifying mRNA ARCT-154
COVID-19 vaccine: 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.
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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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