Three-month data from ARCT-154 booster trial
show persistent neutralizing antibody activity against multiple
variants of SARS-CoV-2
International pivotal Phase 3 booster trial
preparations initiated with global CRO
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Figure 1: Validated pseudovirus
microneutralization (MNT) assay results (left: D614G; right: Beta),
showing GMFR levels of neutralizing antibody responses over Day 1
(baseline levels prior to boosting with ARCT-154) calculated with
virus neutralization concentrations (with 95% confidence intervals)
obtained for participants (for D614G: n = 12/12 for Days 1, 91 and
11/12 for Days 15 29; For Beta: n = 12/12 for Days 1, 29, 91 and
11/12 for Day 15). (Graphic: Business Wire)
The release reads:
ARCTURUS REPORTS STRONG THREE-MONTH
DURABILITY RESULTS FROM ARCT-154 BOOSTER TRIAL
Three-month data from ARCT-154 booster trial
show persistent neutralizing antibody activity against multiple
variants of SARS-CoV-2
International pivotal Phase 3 booster trial
preparations initiated with global CRO
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines
company focused on the development of infectious disease vaccines
and significant opportunities within liver and respiratory rare
diseases, today provided updated data from its Phase 1/2 booster
clinical trial showing durability of antibody response with
ARCT-154 for at least three months after low-dose (5 mcg)
booster.
“We are very pleased to see our self-amplifying mRNA vaccine
ARCT-154 demonstrate meaningful and durable increases of
neutralizing antibodies against SARS-CoV-2 and variants of concern
– for at least three months,” said Joseph Payne, President and CEO
of Arcturus Therapeutics. “These results provide additional
validation of Arcturus’ next generation STARR™ mRNA technology for
vaccines.”
In the ARCT-154 arm of the ongoing Phase 1/2 booster study in
the U.S. and Singapore, data from neutralizing antibody assays
demonstrate that booster vaccination generated strong immune
responses, both with respect to the magnitude of response and
duration of response for at least three months post-boost. Twelve
participants in this arm received 5 mcg of ARCT-154 at least five
months after receiving two primary doses of Comirnaty®. Results
from validated pseudovirus microneutralization assay (MNT) to
detect responses against the D614G SARS-CoV-2 strain (Figure 1,
left) show a single 5 mcg dose of ARCT-154 led to neutralizing
antibody responses that remained 30-fold (p =0.007) elevated for
geometric mean fold rise (GMFR) over baseline (pre-boost) levels at
three months after vaccination. 28-fold and 40-fold increases in
neutralizing antibody responses from baseline levels were seen on
Day 15 and Day 29, respectively. Validated pseudovirus MNT assay
for the Beta strain also demonstrated notable durability of
neutralizing antibody response with 24-fold (p = 0.017) GMFR at
three months after booster vaccination, compared to 26-fold and
31-fold over baseline on Day 15 and Day 29, respectively (Figure 1,
right).
Similar to the microneutralization responses, surrogate virus
neutralization (sVNT) assay results evaluating a panel of
SARS-CoV-2 strains (Figure 2) also illustrated persistent and broad
neutralizing antibody responses. Three months following booster
dose administration of ARCT-154, antibody responses remained 13 to
30-fold elevated over Day 1 (pre-boost) baseline for all SARS-CoV-2
strains tested. Samples from the trial will be further analyzed for
neutralizing antibody activity against different strains of
SARS-CoV-2, including the Omicron lineage.
The Company has initiated start-up activities with an
international CRO toward a pivotal Phase 3 booster trial intended
to support global registration.
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA
medicines and vaccines company with enabling technologies: (i)
LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and
(iii) mRNA drug substance along with drug product manufacturing
expertise. Arcturus’ diverse pipeline of RNA therapeutic and
vaccine candidates includes mRNA vaccine programs for SARS-CoV-2
(COVID-19) and influenza, and other programs to potentially treat
ornithine transcarbamylase (OTC) deficiency, and cystic fibrosis
along with partnered programs including glycogen storage disease
type III (GSD III), hepatitis B virus (HBV), and non-alcoholic
steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics
platforms can be applied toward multiple types of nucleic acid
medicines including messenger RNA, small interfering RNA, replicon
RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics.
Arcturus’ technologies are covered by its extensive patent
portfolio (with patents and patent applications issued in the U.S.,
Europe, Japan, China and other countries). Arcturus’ commitment to
the development of novel RNA therapeutics has led to collaborations
with Janssen Pharmaceuticals, Inc., part of the Janssen
Pharmaceutical Companies of Johnson & Johnson, Ultragenyx
Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited,
CureVac AG, Duke-NUS Medical School, and the Cystic Fibrosis
Foundation. For more information visit www.ArcturusRx.com. In
addition, please connect with us on Twitter and LinkedIn.
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 strategy, future operations,
the expectations for or likelihood of success of any
collaborations, the promise of the company’s platform technologies
for multiple types of nucleic acid medicines, the likelihood that
ARCT-154 will be advanced or receive any regulatory approval, the
likelihood that the ARCT-154 data from the booster study, or any
other non-clinical or clinical data, will be predictive of future
clinical results, efficacy, durability for longer periods of time
or results against COVID variants, the likelihood that ARCT-154
data will be sufficient for any regulatory approval, the timing,
design (including number of participants), initiation, conduct or
completion of a pivotal booster study of ARCT-154 or any other
clinical trial, the Company’s expectation of sharing further
analysis from evaluation of sera samples, the likelihood that a
patent will issue from any patent application, and the impact of
general business and economic conditions. Arcturus may not actually
achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in any forward-looking
statements such as the foregoing and 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 that may cause
our or our industry’s actual results, levels of activity,
performance or achievements to be materially different from those
anticipated by the forward-looking statements, 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.
Trademark Acknowledgements
The Arcturus logo and other trademarks of Arcturus appearing in
this announcement, including LUNAR® and STARR™, are the property of
Arcturus. All other trademarks, services marks, and trade names in
this announcement are the property of their respective owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20220505005501/en/
IR and Media Contacts Arcturus Therapeutics Deepankar
Roy, Ph.D. Senior Director, Investor Relations (858) 900-2682
IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
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