Arcturus Therapeutics Announces that it has Initiated Dosing of its COVID-19 STARR™ mRNA Vaccine Candidate, LUNAR-COV19 (AR...
11 Agosto 2020 - 7:01AM
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 that all subjects in the first cohort
have been dosed in the Phase 1/2 clinical study with its ARCT-021
investigational vaccine for COVID-19. The study is being conducted
with CTI Clinical Trial and Consulting Services, a global CRO, and
in collaboration with Duke-NUS Medical School in Singapore.
“We are very pleased to have initiated dosing in
our ARCT-021 Phase 1/2 study, and in fact, we have already
completed dosing of all subjects in the first cohort of the study.
Based on preclinical immunogenicity data, our self-replicating
mRNA-based investigational vaccine could have a highly
differentiated safety and efficacy profile, and may potentially
allow vaccination at very low doses, and with a single
administration. These favorable attributes could greatly facilitate
mass vaccination campaigns necessary to control this global
pandemic,” said Joseph Payne, President & CEO of Arcturus. “We
look forward to sharing initial clinical data from this Phase 1/2
study in Q4 which we expect to enable dose selection for late phase
clinical trials.”
The ARCT-021 Phase 1/2 study includes two parts.
In Phase 1, escalating doses will be administered as a single
injection to younger adults aged 21 to 55 years old. Based upon the
safety, immunogenicity and T-cell response data from this group,
dose regimens will be selected for further evaluation in Phase 2
which includes cohorts in younger adults and older adults aged 56
to 80 years old. The study is listed with ClinicalTrials.gov
Identifier: NCT04480957.
ARCT-021 preclinical data has shown highly
promising results with 100% seroconversion for neutralizing
antibodies after a single administration using a very low 2 µg
dose. Neutralizing antibodies continued to increase for 60 days
after dosing. Preclinical results also demonstrated robust CD8+
T-cell Induction and a Th1 biased T-helper cellular immune
response. The ARCT-021 vaccine candidate is devoid of viruses and
does not utilize viral vectors or adjuvants. ARCT-021 utilizes
Arcturus’ self-transcribing and replicating (STARR™) mRNA
technology and is delivered with Arcturus’s proprietary LUNAR®
lipid-mediated delivery system.
About Arcturus
TherapeuticsFounded 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 self-replicating mRNA
vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other
programs to potentially treat Ornithine Transcarbamylase (OTC)
Deficiency, Cystic Fibrosis, Cardiovascular Disease along with
partnered programs including Glycogen Storage Disease Type 3,
Hepatitis B Virus, 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 (192 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, Synthetic Genomics
Inc., Duke-NUS, and the Cystic Fibrosis Foundation. For more
information visit www.ArcturusRx.com
Forward Looking StatementsThis
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, including those regarding the likelihood of
success, efficacy or safety of ARCT-021 as a vaccine against
COVID-19 and therapeutic potential thereof based on the Company’s
mRNA therapeutics, the timing of the release of ARCT-021 clinical
data for human trials of a vaccine against COVID-19, the likelihood
that ARCT-021 preclinical data will be predictive of clinical data,
the expected dose size and required number of doses of ARCT-021
that may be approved for use by any applicable regulatory authority
and the impact of general business and economic conditions are
forward-looking statements. 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. Such statements are based on
management’s current expectations and involve risks and
uncertainties, including those discussed under the heading "Risk
Factors" in Arcturus’ Annual Report on Form 10-K for the fiscal
year ended December 31, 2019, filed with the SEC on March 16, 2020
and in subsequent filings with, or submissions to, the SEC. 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.
IR and Media ContactsArcturus TherapeuticsNeda
Safarzadeh (858) 900-2682 IR@ArcturusRx.com
Kendall Investor RelationsCarlo Tanzi, Ph.D. (617)
914-0008 ctanzi@kendallir.com
Clinical Site
ContactEmail: imu@singhealth.com.sgPhone: 6323
7544/8318 0685
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