Arcturus Therapeutics Announces Preclinical Publication of its COVID-19 Vaccine Candidate
September 04 2020 - 10:31AM
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 its manuscript is now available on
an online preprint server at Bioarchive and is concurrently
undergoing scientific peer review. The manuscript provides an
in-depth assessment of humoral- and cell-mediated immune activation
following a single shot vaccination in mice and shows that
LUNAR®-COV19 (ARCT-021) produced robust antibody responses, with
neutralizing antibody titers increasing up to day 60. In
addition, single doses of LUNAR®-COV19 at both the 2 μg and 10 μg
levels completely protected human ACE2 transgenic mice from both
mortality and even measurable infection following wild-type
SARS-CoV-2 challenge. The Company believes that the findings from
this study, which was conducted in collaboration with Duke-NUS
Medical School, collectively suggest the potential of LUNAR®-COV19
as a single dose vaccine. The Company is currently evaluating
LUNAR®-COV19 in a Phase 1/2 clinical study.
The publication: de Alwis et al., A Single Prime
Self-Transcribing and Replicating RNA Based SARS-CoV-2 Vaccination
Produces Protective Adaptive Immunity is available on the
Bioarchive website
https://www.biorxiv.org/content/10.1101/2020.09.03.280446v1
“The data we have in preprint at Bioarchive
continues to provide strong support for the potent immunogenicity
of LUNAR®-COV19. Results demonstrate that a single vaccination in
mice led to robust antibody responses, with neutralizing antibody
titers increasing up to day 60. Furthermore, activation of cell
mediated immunity produced a strong viral antigen specific CD8+ T
lymphocyte response and a desirable Th1 dominant immune response.
Importantly, a single LUNAR®-COV19 vaccination at very low
microgram doses resulted in complete protection from infection and
death from SARS-CoV-2 in a transgenic human ACE2 mouse challenge
model, with no detectable virus present in LUNAR®-COV19 vaccinated
mice,” said Professor Ooi Eng Eong, Deputy Director, Emerging
Infectious Diseases Programme, Duke-NUS Medical School and a member
of Arcturus’ Vaccine Platform Scientific Advisory Board.
“Our findings highlight the potential of
LUNAR®-COV19 to be a highly potent, low dose, single shot vaccine.
These favorable attributes may provide a substantial benefit
compared to the multiple vaccine dosing regimens that are more
commonly being developed. We believe that this advantageous profile
could greatly facilitate the mass vaccination campaigns necessary
to control the global COVID-19 pandemic,” said Pad Chivukula,
Ph.D., CSO & COO of Arcturus.
About STARR™ TechnologyThe STARR™
Technology platform combines self-replicating RNA with LUNAR®, a
leading nanoparticle delivery system, into a single solution to
produce proteins inside the human body. The versatility of
the STARR™ Technology enables it upon delivery into the cell to
generate a protective immune response or drive therapeutic protein
expression to potentially prevent against or treat a variety of
diseases. The self-replicating RNA-based prophylactic vaccine
triggers rapid and prolonged antigen expression within host cells
resulting in protective immunity against infectious pathogens. This
combination of the LUNAR® and STARR™ technology is expected to
provide lower dose requirements due to superior immune response,
sustained protein expression compared to non-self-replicating
RNA-based vaccines and potentially enabling to produce vaccines
more quickly and simply.
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 Company’s
efforts to develop a vaccine against COVID-19, and therapeutic
potential thereof, based on the Company’s mRNA therapeutics, the
Company’s ongoing Phase 1/2 and availability of expected results,
the potential of the vaccine against COVID-19 as a single dose
vaccine 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. No
assurances can be given that any results reported in pre-clinical
studies can be replicated in further studies or in human beings, or
that a vaccine can or will ever be developed or approved using the
Company’s technology. 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
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