Arcturus Reports Durability Data Against Omicron Variants, Including BA.5, at Six-Month Timepoint Following Booster with ARCT-154 COVID-19 Vaccine
18 August 2022 - 10:00PM
Business Wire
New clinical data demonstrate high and
sustained geometric mean fold rises (GMFR) in neutralizing
antibodies against all evaluated Omicron variants
Six months after booster dose of
ARCT-154: BA.1: GMFR = 22 to 52; Titer = 674 to 1524 BA.2: GMFR
= 25 to 55; Titer = 777 to 1713 BA.5: GMFR = 9 to 24; Titer = 295
to 730
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
“Arcturus Therapeutics”, 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 announced updated data
from its ongoing ARCT-154 booster clinical trial. The new results
demonstrate broad neutralizing antibody response against Omicron
variants of concern, including BA.5, lasting for up to at least six
months after administration of low-dose (5 mcg) ARCT-154
booster.
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Exploratory pseudovirus
microneutralization (MNT) assay results (left: BA.1, middle: BA.2,
right: BA.5), showing geometric mean fold rise (GMFR) levels of
neutralizing antibody responses over Day 1 (baseline levels prior
to boosting with 5 mcg ARCT-154) calculated with virus
neutralization concentrations (with 95% C.I.) obtained for n=12
participants at days 29 and 91. In Figure A, three participants
were removed from the day 181 analysis (n=9, day 181): two
participants received off-study vaccines during the period between
day 91 and day 181, and one participant has a confirmed COVID-19
diagnosis with mild symptoms during this same period. In Figure B,
three additional participants with suspected asymptomatic
seroconversion were removed from the day 181 analysis (n=6, day
181). Neutralizing antibody responses against Omicron variants
BA.1, BA.2, and BA.5 were measured at the Moore Lab in South
Africa. (Graphic: Business Wire)
“Our next generation low-dose self-amplifying (STARR™) mRNA
technology continues to differentiate itself from conventional mRNA
vaccine technology as a highly and broadly immunogenic endemic
vaccine platform with durable responses against the most
challenging variants including Omicron BA.5 for at least 6 months,”
said Joseph Payne, President and CEO of Arcturus Therapeutics.
“Further validation of the breadth and duration for the immune
responses to ARCT-154 are planned in upcoming pivotal clinical
trial activities.”
Data shown above illustrate the ongoing antibody responses to
single, low (5 microgram) booster doses of ARCT-154 in healthy
adults (n=12) previously vaccinated with Comirnaty®. Samples taken
at one, three, and six months after vaccination are shown.
After one month (day 29) and three months (day 91), neutralizing
antibody responses to Omicron BA.5 were 33- and 20-fold elevated
over pre-boost responses, respectively. After six months (day 181),
neutralizing antibody responses to Omicron BA.1, BA.2, BA.5 ranged
from 22- to 52-fold, 25- to 55-fold, and 9 to 24-fold elevated over
pre-boost responses, respectively.
These data show sustained neutralizing responses to
antigenically distinct variants of concern, including Omicron BA.5,
for at least six months after vaccination.
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage
clinical mRNA medicines and vaccines company with enabling
technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA
Technology (samRNA) 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, and hepatitis B virus. 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 protected by
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 including,
amongst others, Janssen Pharmaceuticals, Inc., part of the Janssen
Pharmaceutical Companies of Johnson & Johnson, Ultragenyx
Pharmaceutical, Inc., and the Cystic Fibrosis Foundation. Please
connect with us on Twitter and LinkedIn. For more information visit
www.ArcturusRx.com.
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), the likelihood that the updated data from the ongoing
ARCT-154 booster trial will be predictive of future clinical
results (including with respect to safety, immunogenicity and
efficacy), the planned initiation, design or completion of a
pivotal booster trial, 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
IR@arcturusrx.com Kendall Investor Relations Carlo Tanzi, Ph.D.
(617) 914-0008 ctanzi@kendallir.com
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