Preliminary data from ongoing clinical booster
study of ARCT-154 (5 mcg) shows a 50-fold increase in neutralizing
antibody geometric mean concentration against SARS-CoV-2 using a
validated pseudovirus microneutralization (MNT) assay
Additional data shows activity against several
variants of concern and variants of interest upon boosting with
ARCT-154 (5 mcg) and ARCT-165 (5 mcg) in a surrogate virus
neutralization (sVNT) assay
Company to evaluate sera from ARCT-154 and
ARCT-165 vaccinated participants for activity against the omicron
variant; initial data anticipated Q1 2022
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 new data and updates from clinical
development programs for ARCT-154 and ARCT-165, its
investigational, next-generation, self-amplifying mRNA vaccine
candidates targeting variants of concern.
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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 = 8/12) and ARCT-165 (right; n =
9/12). Within each panel, the left graphic shows values from
individuals, and the right graphic shows the geometric means of
neutralization concentrations, with 95% confidence intervals. The
multiples are geometric mean-fold rises (GMFR) of neutralization
concentrations on Day 15 over Day 1 values. Geometric mean for Day
29 is not shown here as data from only four participants are
available for this time point.
ARCT-154 and ARCT-165 are being studied in a Phase 1/2 trial,
sponsored by Arcturus, in U.S. and Singapore. The study is
evaluating Arcturus’ COVID vaccine candidates as both a primary
vaccination series and as a booster following initial vaccination
with Comirnaty®. ARCT-154 is also currently being studied in an
ongoing pivotal trial in Vietnam, sponsored and funded by Arcturus’
collaborator Vinbiotech.
Preliminary immunogenicity results from the first eight of 12
participants administered ARCT-154 and the first nine of 12
administered ARCT-165 as a booster following initial vaccination
with Comirnaty® in the ongoing Phase 1/2 study demonstrates an
encouraging increase in neutralizing antibody titers following
booster vaccination, as measured by a validated pseudovirus (D614G
variant) microneutralization (MNT) assay as well as in an
exploratory surrogate virus neutralization assay (sVNT) assessing
responses to multiple variants of concern and variants of interest,
including the alpha, beta, gamma and delta strains.
“The booster data showing a rise in neutralizing antibody levels
and potentially broad coverage across variants, while preliminary,
is encouraging and provides support for the continued development
of our next-generation self-amplifying mRNA vaccine candidates as
differentiated, low-dose vaccines that may be effective boosters
for continued prevention of infections caused by variants of
concern,” said Joseph Payne, President and CEO of Arcturus
Therapeutics. “We await the data from the pivotal Phase 1/2/3 study
of ARCT-154 and anticipate commencing the submission of regulatory
documents to the Ministry of Health in Vietnam this month, with
completion of Emergency Use Authorization application in the first
quarter of 2022, assuming positive data.”
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 in the
booster trial 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 pseudovirus microneutralization (MNT) and
surrogate virus neutralization (sVNT) assays, respectively,
performed with sera from the first eight participants in the
ARCT-154 group, and from the first nine participants in the
ARCT-165 group. The company anticipates updating the results as
subsequent data become available in the coming weeks.
Arcturus and Vinbiotech anticipate commencing the submission of
regulatory documents to the Vietnam Ministry of Health (MoH) this
month for emergency use authorization (EUA) application for
ARCT-154. Contingent upon additional requirements of the MoH, the
submission is anticipated to be completed in the first quarter of
2022.
Arcturus also plans to evaluate sera from ARCT-154 and ARCT-165
vaccinated participants for activity against the SARS-CoV-2 omicron
variant and expects to obtain preliminary data in the first quarter
of 2022.
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 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
experimental or preclinical work (including the evaluation of
vaccine candidates against the omicron variant and other COVID-19
variants), the planned initiation, design or completion of clinical
trials (including the timely completion of the Phase 1/2/3 study of
ARCT-154), the likelihood that the Company will obtain clearance
from regulatory authorities to proceed with future planned clinical
trials, the likelihood that subsequent data from a study will be
consistent with preliminary data (including with respect to the
preliminary immunogenicity data of ARCT-154 and ARCT-165), the
likelihood that preclinical or clinical data will be predictive of
future clinical results or efficacy or safety of a candidate
(including with respect to the immunogenicity results of ARCT-154
and ARCT-165 as a booster in the ongoing Phase 1/2 study), the
ability to enroll, and timing for enrollment of, subjects in
clinical trials, the timing and nature of any study results
(including the results of the Phase 1/2/3 study in Vietnam), the
likelihood that clinical data will be sufficient for regulatory
approval or completed in time to submit an application for
regulatory approval within a particular timeframe (including the
timing for submission of an application for emergency use
authorization in Vietnam), the likelihood or timing of any
regulatory approval (including with respect to an EUA in Vietnam),
the potential administration regimen or dosage, or ability to
administer multiple doses of, any of the Company’s drug candidates,
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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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
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