Full cohort data from the ARCT-154 (5 mcg) arm
of the ongoing Phase 1/2 booster study shows 30-fold increase in
neutralizing antibody geometric mean concentrations against
SARS-CoV-2 at Day 15 post-boost, maintained at 28-fold increase at
Day 29, using a validated pseudovirus microneutralization (MNT)
assay
Robust neutralizing antibody responses observed
post-boost for both ARCT-154 (5 mcg) and ARCT-165 (5 mcg) against
several variants of concern and variants of interest in a surrogate
virus neutralization (sVNT) assay
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines
company focused on the development of infectious disease vaccines
and significant opportunities within liver and respiratory rare
diseases, today announced updated data from clinical development
programs for ARCT-154 and ARCT-165, its investigational,
next-generation, self-amplifying mRNA vaccine candidates targeting
the variants of concern.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20220124005288/en/
Figure 1: Pseudovirus (D614G variant)
microneutralization (MNT) assay results. Virus neutralization
concentrations (arbitrary units per milliliter, AU/mL) for
participants at Day 1 (prior to boosting), and Days 15 and 29 after
boosting with ARCT-154 (left; n = 12/12 for Days 1 and 29, 11/12
for Day 15) and ARCT-165 (right; n = 12/12 all time points). Within
each panel, the left graphic shows values from individuals, and the
right graphic shows the geometric mean neutralization
concentrations, with 95% confidence intervals. The multiples are
fold rises of neutralization concentrations on Day 15 and Day 29,
respectively, over Day 1 values. (Graphic: Business Wire)
Data from the Phase 1/2 booster trial, sponsored by Arcturus and
currently ongoing in U.S. and Singapore, show that both ARCT-154
and ARCT-165, when administered as low-dose (5 mcg) boosters at
least five months following initial vaccination with Comirnaty®,
demonstrated robust geometric mean antibody responses against
SARS-CoV-2 as measured in a validated pseudovirus
microneutralization (MNT, D614G) assay and neutralizing antibody
concentrations were maintained between 15 and 29 days
post-administration. These results, along with the robust levels of
neutralizing antibodies recorded against several variants of
concern (including Alpha, Beta, Gamma, and Delta) in this study, as
measured by a surrogate virus neutralization (sVNT) assay are
expected to support further clinical development of these
candidates as booster vaccines.
“We continue to gather highly encouraging data from our
next-generation, self-amplifying mRNA vaccine candidates ARCT-154
and ARCT-165 that have now both demonstrated encouraging
neutralizing antibody concentrations against a broad range of
variants upon boosting,” said Joseph Payne, President and CEO of
Arcturus Therapeutics. “We believe the STARR™ self-amplifying mRNA
technology is an ideal platform that could address the ongoing need
for updated booster vaccines at substantially lower dose levels,
not just for COVID-19, but also for other infectious diseases.”
In the ARCT-154 and ARCT-165 arms of the booster cohort of the
ongoing Phase 1/2 study being conducted in the U.S. and Singapore,
24 participants divided into two equal groups of 12 received 5
micrograms of ARCT-154 or ARCT-165 following primary vaccination
with Comirnaty® at least 5 months earlier. All participants were
below 65 years of age at the time of receiving the booster dose.
Figures 1 and 2 show the Day 15 and Day 29 post-boost results from
validated pseudovirus microneutralization (MNT) and exploratory
surrogate virus neutralization (sVNT) assays, respectively,
performed with sera from the participants in the ARCT-154 and
ARCT-165 groups.
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 likelihood of success (including safety and
efficacy) of the Company’s platform or pipeline (including ARCT-154
and ARCT-165), the Company’s efforts to develop a vaccine against
COVID-19 and therapeutic potential thereof based on the Company’s
mRNA therapeutics, the planned initiation, design or completion of
clinical trials, the likelihood that the Company will obtain
clearance from regulatory authorities to proceed with future
planned clinical trials, the likelihood that preclinical or
clinical data will be predictive of future clinical results
(including with respect to safety, immunogenicity and efficacy),
the likelihood that a preliminary, interim or partial data set will
be representative of a complete or larger data set, the likelihood
that clinical data will be sufficient to support further clinical
development, for regulatory approval or will be completed in time
to submit an application for regulatory approval within a
particular timeframe, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220124005288/en/
IR and Media Contacts Arcturus Therapeutics Deepankar
Roy, Ph.D. (858) 900-2682 IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
Arcturus Therapeutics (NASDAQ:ARCT)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024
Arcturus Therapeutics (NASDAQ:ARCT)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024