- Demand for Therapeutic DNA Drives Inquiries
for Bulk LinearDNA -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA), a
leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing
and nucleic acid-based technologies, and its majority-owned
subsidiary LineaRx, Inc., a manufacturer of LinearDNA™ via PCR for
nucleic acid therapeutics and diagnostics, today announced the
receipt of repeat orders from diagnostic customers and a first
Contract Research Organization (CRO) order from a new
biotherapeutic customer, a federally funded research and
development laboratory focused on cancer research. PCR-produced
LinearDNA serves as a pure, fast, and flexible alternative to
plasmid DNA (pDNA) in the manufacture of cell and gene therapies
(CGTs) and nucleic acid vaccines. CRO orders typically provide a
means to evaluate LinearDNA within a customer’s preclinical
development program.
LineaRx has recorded an uptick in CRO orders for LinearDNA in
recent quarters. Although a limited number of CGTs are currently on
the market, FDA officials predicted in 2019 that the agency will
receive more than 200 investigational new drug applications per
year for cell and gene therapies and that by 2025, it expects to
have accelerated to 10 to 20 cell and gene therapy approvals per
year1. As a result of the COVID-19 pandemic, nucleic acid therapies
have also moved to the forefront of biotherapeutic science with the
successful deployment of mRNA vaccines against the virus.
Most evaluations of LinearDNA currently center on its use in the
development of preclinical CAR T therapies, a use case highlighted
in a recently published study that utilized LinearDNA in a
non-viral manufacture of CD19-specific CAR T cells2. CRO customers
are also evaluating LinearDNA for use in mRNA template manufacture,
recombinant adeno-associated virus manufacture, and in vivo
expression vectors.
Applied DNA and LineaRx CEO Dr. James A. Hayward stated, “We
view CRO orders as a leading indicator of LinearDNA adoption that
potentially foreshadows our future role as Contract Development and
Manufacturing Organization (CDMO) – the economics of a CDMO far
exceeding those of a CRO – to a future generation of CGTs and
vaccines. As global demand for therapeutic DNA for GCTs and
vaccines steadily grows, we believe developers’ requirements are
increasingly centered on higher quality and more scalable DNA
production that surpasses the capacity that can be met by the pDNA
industry today. This demand is forcing innovator companies into
‘build versus buy’ decisions that we believe are tipping in our
favor. We are beginning to field inbound interest in LinearDNA
today that are magnitudes above what we have experienced
historically both in terms of volume and value.”
Concluded Dr. Hayward, “We believe the COVID-19 pandemic,
increasing interest in CGTs, and nucleic acid vaccines are
highlighting the shortcomings of pDNA manufacturing. Having
established our DNA expertise over the past 15 years that is
backstopped by a strong IP portfolio, and with our current ability
to produce LinearDNA at GLP levels soon to be upgraded to an
initial cGMP production capacity, we are moving quickly to position
LinearDNA as a disruptive force in the market for therapeutic
DNA.”
References:
- Statement from then FDA Commissioner Scott Gottlieb, MD, and
Peter Marks, MD, PhD, director of the Center for Biologics
Evaluation and Research on new policies to advance development of
safe and effective cell and gene therapies. News release. FDA
website. January 15, 2019.
https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics.
- I. Kastankova, et alia, “Enzymatically produced piggyBac
transposon vectors for efficient non-viral manufacturing of
CD19-specific CAR T cells,” Mol Ther Methods Clin Dev. 2021 Aug
26;23:119-127. doi: 10.1016/j.omtm.2021.08.006. eCollection 2021
Dec 10
About LineaRx, Inc., and LinearDNA™ LineaRx seeks to
commercialize the biotherapeutic value of Applied DNA's deep
expertise and experience in the design, manufacture, and chemical
modification of DNA by large-scale polymerase chain reaction
("PCR") via its LinearDNA Platform.
The LinearDNA Platform is a proprietary large-scale PCR-based
manufacturing platform that allows for the large-scale production
of specific high-fidelity DNA sequences. Unlike plasmid-derived
DNA, LinearDNA is free of adventitious DNA sequences and can be
chemically modified to optimize the DNA for specific applications.
The LinearDNA platform is currently being used by customers to
manufacture DNA as components of in vitro diagnostic tests and for
preclinical nucleic acid-based drug development in the fields of
adoptive cell therapies (CAR T and TCR therapies), DNA vaccines
(anti-viral and cancer), RNA therapies, clustered regularly
interspaced short palindromic repeats-based (CRISPR) therapies and
gene therapies, as well as the Company's COVID-19 veterinary
vaccine candidate.
About Applied DNA Sciences Applied DNA is commercializing
LinearDNA™, its proprietary, large-scale polymerase chain reaction
(“PCR”)-based manufacturing platform that allows for the
large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in
vitro diagnostics and preclinical nucleic acid-based drug
development and manufacturing market. The platform is used to
manufacture DNA for customers as components of in vitro diagnostic
tests and for preclinical nucleic acid-based drug development in
the fields of adoptive cell therapies (CAR T and TCR therapies),
DNA vaccines (anti-viral and cancer), RNA therapies, clustered
regularly interspaced short palindromic repeats (CRISPR) based
therapies, and gene therapies. Applied DNA has also established a
COVID-19 diagnostic and testing offering that is grounded in the
Company’s deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such
as supply chain security, anti-counterfeiting and anti-theft
technology. Key end-markets include Gov/Mil, textiles,
pharmaceuticals and nutraceuticals, and cannabis, among others.
Visit adnas.com for more information. Follow us on Twitter and
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The Company’s common stock is listed on NASDAQ under ticker
symbol ‘APDN,’ and its publicly traded warrants are listed on OTC
under ticker symbol ‘APPDW.’
Applied DNA is a member of the Russell Microcap® Index.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be
“forward-looking” in nature within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform 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
or its partner’s therapeutic candidates will advance further in the
preclinical research or clinical trial process, including receiving
clearance from the U.S. Food and Drug Administration (FDA) or
equivalent foreign regulatory agencies to conduct clinical trials
and whether and when, if at all, they will receive final or
conditional approval from the FDA or equivalent foreign regulatory
agencies, the unknown outcome of any applications or requests to
FDA or equivalent foreign regulatory agencies, whether results from
preclinical studies will be predictive of the results of later
preclinical studies and clinical trials, the unknown ability to
manufacture therapeutic grade DNA in large quantities, the fact
that there has never been a commercial drug product utilizing
PCR-produced DNA technology approved for therapeutic use, 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 17, 2020 and Form 10-Q filed on February 11,
2021, May 13, 2021 and August 12, 2021 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, events or circumstances
after the date hereof or to reflect the occurrence of unanticipated
events, unless otherwise required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20211115005652/en/
Investor Contact: Sanjay M. Hurry, 917-733-5573,
sanjay.hurry@adnas.com Program Manager: Brian Viscount,
631-240-8877, brian.viscount@adnas.com Web: www.adnas.com
Twitter: @APDN
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