LineaRx Receives Multiple Purchase Orders for Linear DNA for Use in Therapeutic Development
01 July 2019 - 11:25PM
Business Wire
Orders Reflect Growing Interest across the
Biotech Industry for Bacteria-Free, Plasmid-Free Therapies
LineaRx, Inc., a wholly-owned subsidiary of Applied DNA
Sciences, Inc. (“Applied DNA or the Company,” NASDAQ:APDN),
announced today that it has received multiple purchase orders, from
several major developers of gene and cell therapies, for its
proprietary and patented large-scale, polymerase-chain-reaction
(PCR)-produced linear DNA. LineaRx believes this momentum reflects
increasing interest across the biotech industry to pursue a
cleaner, higher-performing alternative to plasmid DNAs that are
produced by fermentation in bacteria.
Under these Phase 1 CRO (Contract Research Organization)
agreements, the performance of linear DNA will be benchmarked by
criteria such as gene expression, and cell viability, against
existing data from DNA produced using plasmids. LineaRx will also
optimize, produce, and purify the products as required for testing
both in vitro and in vivo by our customers. Upon successful
benchmarking, LineaRx expects these customers will proceed to Phase
2 studies that leverage additional LineaRx intellectual property to
enhance expression levels or expression lifetimes to drive greater
therapeutic performance, while optimizing costs.
“In a number of completed studies, our linear DNA has met or
exceeded the performance of plasmid DNA, as measured by gene
expression, cell viability, and immunogenicity,” stated Dr. James
Hayward, president and CEO of LineaRx. “These new Phase 1 CRO
studies will seek to establish the performance of our linear DNA
with several significant biotech companies focused on gene and cell
therapies, including those focused on adoptive cellular therapies
as well as RNA-based therapeutics. This increasing interest that
encompasses a broad spectrum of industry players is an early, yet
important, endorsement of our view that our proprietary PCR
technology offers the potential for improved outcomes relative to
current plasmid and viral-vector production technologies.”
To produce the quantities of DNA required for therapeutics,
plasmid DNA is grown in bacteria and requires a costly purification
process in an attempt to remove bacterial and non-target plasmid
DNA, as well as bacterial toxins, before the purified DNA is used.
It is commonly known that residual unintended DNA may still be
present worrisome concentrations in the final product. LineaRx
intends to eliminate the risk associated with the presence of
bacterial or unintended plasmid DNA in current therapies via its
expertise in the design, manufacture and chemical modification of
DNA by large scale PCR.
“We attribute the increase in CRO orders, from marquis
companies, to the growing desire to eliminate the risk associated
with the presence of bacterial or unintended plasmid DNA in their
therapies,” added Hayward. “We expect these CRO projects will
evolve to CMO (Contract Manufacturing Organization) orders as some
of these customers, once through their pre-clinical work, will
bring linear DNA-based therapies to clinical trial within the next
18 months.”
About LineaRx LineaRx seeks to commercialize the
biotherapeutic value of Applied DNA Science’s deep expertise and
experience in the design, manufacture and chemical modification of
DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is
a form of DNA distinct from the circular form of DNA most commonly
produced in plasmids and grown in bacteria. Plasmids are
extrachromosomal DNA found in bacteria and are associated with the
genes for antibiotic resistance which are often exchanged between
bacteria and consequentially, are seen by many to embody a serious
threat to global health. In addition, many nucleic acid-based
therapies also rely on viral vectors for efficient transfection and
expression of plasmid DNA. These viral vectors carry additional
nontrivial risks and are extremely time consuming and expensive to
manufacture.
About Applied DNA Sciences Applied DNA is a provider of
molecular technologies that enable supply chain security,
anti-counterfeiting and anti-theft technology, product genotyping
and pre-clinical nucleic acid-based therapeutic drug
candidates.
Applied DNA makes life real and safe by providing innovative,
molecular-based technology solutions and services that can help
protect products, brands, entire supply chains, and intellectual
property of companies, governments and consumers from theft,
counterfeiting, fraud and diversion.
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Common stock listed on NASDAQ under the symbol APDN, and
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Forward-Looking Statements The statements made by Applied
DNA in this press release may be “forward-looking” in nature within
the meaning of the Private Securities Litigation Act of 1995.
Forward-looking statements describe Applied DNA’s future plans,
projections, strategies and expectations, and are based on
assumptions and involve a number of risks and uncertainties, many
of which are beyond the control of Applied DNA. Actual results
could differ materially from those projected due to its history of
net losses, limited financial resources, limited market acceptance
, the uncertainties inherent in research and development, future
clinical data and analysis, including whether any of Applied DNA’s
product candidates will advance further in the preclinical research
or clinical trial process, including receiving clearance from the
U.S. Food and Drug Administration or equivalent foreign regulatory
agencies to conduct clinical trials and whether and when, if at
all, they will receive final approval from the U.S. FDA or
equivalent foreign regulatory agencies, ability to maintain its
NASDAQ listing and various other factors detailed from time to time
in Applied DNA’s SEC reports and filings, including our Annual
Report on Form 10-K filed on December 18, 2018 and our subsequent
quarterly reports on Form 10-Q filed on February 7, 2019 and May 9,
2019, and other reports we file with the SEC, which are available
at www.sec.gov. Applied DNA undertakes no obligation to update
publicly any forward-looking statements to reflect new information,
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occurrence of unanticipated events, unless otherwise required by
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investors: Sanjay M. Hurry, LHA Investor Relations,
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linearxdna.com twitter: @APDN, @LineaRxDNA
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