Arcturus Therapeutics Collaborates with Vingroup to Establish Manufacturing Facility in Vietnam for Arcturus’ Investigational mRNA Vaccines for COVID-19
02 Agosto 2021 - 6:00AM
Business Wire
Arcturus will receive $40 million upfront
payment and potential royalties based on vaccines produced
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, announced today an agreement with Vinbiocare
Biotechnology Joint Stock Company (“Vinbiocare”), a member of
Vingroup Joint Stock Company, regarding a collaboration to
establish a manufacturing facility in Vietnam for the manufacture
of Arcturus’ investigational COVID-19 vaccines, for sale and use
within Vietnam.
Under the terms of the arrangement, Vinbiocare will, with
consultation from Arcturus, build out a manufacturing facility in
Vietnam, and Arcturus will provide to Vinbiocare access to
proprietary technologies and processes for the manufacture of
Arcturus’ investigational COVID-19 vaccines. Arcturus will provide
Vinbiocare with an exclusive license to manufacture the vaccines in
Vietnam at the facility solely for distribution in Vietnam. The
license and technology transfer applies toward drug product
manufacturing but not toward mRNA drug substance manufacturing.
Technology transfer is underway.
Vinbiocare will make an upfront payment of $40 million and be
responsible for costs associated with the technology transfer.
Vinbiocare will also pay for mRNA drug substance supplied by
Arcturus and royalties on vaccines produced at the Facility.
Arcturus investigational COVID-19 vaccines utilize Arcturus’
self-transcribing and replicating (STARR™) mRNA technology, and the
STARR™ mRNA is delivered with Arcturus’s lipid-mediated delivery
system called LUNAR® delivery system.
“We are very pleased to announce this relationship with
Vingroup, and this contract with its subsidiary Vinbiocare, to help
establish a manufacturing facility for our COVID-19 vaccine
candidate, targeting a capacity of up to 200 million doses per
year. We are looking forward to having a meaningful role in
providing effective and safe COVID-19 vaccine to Vietnam as well as
other countries around the world,” said Joseph Payne, President and
CEO of Arcturus.
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 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 (222
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 Medical School, and the Cystic Fibrosis Foundation.
For more information visit www.ArcturusRx.com. In addition, please
connect with us on Twitter and LinkedIn.
About Vingroup
As the largest private industry conglomerate in Vietnam and one
of the largest in Asia, Vingroup is currently doing business in
three core sectors namely technology, industry and services.
Vingroup has ceaselessly innovated and developed with the aim of
building an ecosystem of premium products and services that meet
international standards, contributing to the improvement of the
Vietnamese people’s life quality and the enhancement of Vietnamese
brand image in the international market. In any sector, Vingroup
has always played the role of a pioneer that leads the change. For
more details, please log on to https://www.vingroup.net/en.
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,
collaborations, the likelihood of success (including safety and
efficacy) of the Company’s pipeline, the Company’s efforts to
develop a vaccine against COVID-19 and therapeutic potential
thereof based on the Company’s mRNA therapeutics, the initiation,
completion or anticipated timeframes for the initiation and
build-out of the manufacturing facility, the initiation, completion
or anticipated timeframes for the planned technology transfer of
manufacturing processes to Vinbiocare, the likelihood that the
Company or its partners will obtain clearance from regulatory
authorities to proceed with planned clinical trials, the likelihood
that the Company or its partners will obtain regulatory approval of
the Company’s product candidates, the Company’s manufacturing
methods and technologies (including lyophilization and fill
finish), the likelihood that a patent will issue from any patent
application, its current cash position and expected cash burn and
the impact of general business and economic conditions. Actual
results and performance could differ materially from those
projected in any forward-looking statements as a result of many
factors including, without limitation, the ability to enroll
subjects in clinical trials as a result of the COVID-19 pandemic,
the impact of commercialization of third-party COVID-19 vaccines on
the design, and ability to conduct, clinical trials, the
availability of manufacturing capacity and raw materials,
unexpected clinical results, government regulations impacting the
regulatory environment or intellectual property landscape, and
general market conditions that may prevent such achievements or
performance. 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, 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.
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IR and Media Contacts Arcturus Therapeutics Neda
Safarzadeh (858) 900-2682 IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
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