- Preclinical Study Details Application of
LinearDNA Suitable for the Cost-Effective Production of CAR T Cells
-
- Results Demonstrate that CAR19 T-cells
Manufactured with LinearDNA Have Similar Efficacy to CAR19 T-cells
Manufactured with Plasmid DNA -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the
“Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing and nucleic acid-based technologies, announced the
publication of a study in Molecular Therapy: Methods and Clinical
Development on a methodology for the manufacture of novel types of
CAR constructs that employ the Company’s LinearDNA™ as part of a
manufacturing process for the efficient generation of CD19-specific
CAR T-cells (CAR19 T-cells) based on co-electroporation of a
LinearDNA transposon and mRNA encoding of piggyBac transposase.
PCR-produced LinearDNA is manufactured by LineaRx, the Company’s
majority-owned subsidiary, to serve as a pure, fast, and flexible
alternative to plasmid DNA (pDNA) for biotherapeutic
applications.
The study, titled “Enzymatically produced piggyBac transposon
vectors for efficient non-viral manufacturing of CD19-specific CAR
T cells”, details the utility of LinearDNA in the cost-effective
production of preclinical CAR T cells. Its authors, members of the
Institute of Hematology and Blood Transfusion (ÚHKT) in Prague,
Czechia, and the Faculty of Natural Sciences at Charles University,
also in Prague, propose that the combination of LinearDNA and a
transposon/transposase system offers therapy developers an
effective research tool for making experimental CAR T cells rapidly
and efficiently without the need for complicated virus production
or the use of pDNA.
Pavel Otáhal, contributing author and Head of the Gene
Immunotherapy Research Department at ÚHKT, stated, “Our study
compares the manufacture of CAR19 T-cells via PCR-made transposon
DNA (LinearDNA) with mRNA encoding of the transposase against a
conventional plasmid approach. We found CAR T efficacy of the
LinearDNA system versus the plasmid system to be identical.
Further, we found no mutations in the coding sequence of LinearDNA
and with >99% purity that obliviated the need for purification
typical of a plasmid approach. As an institution dedicated to
diagnosing and treating serious blood diseases and with the ability
to pursue investigational medicines from development to manufacture
and clinical trial for patients who have exhausted all approved
treatment options, having a cost-effective and rapid production
chain is integral to ÚHKT’s mission. We find LinearDNA to be an
excellent platform for CAR T-cell therapy development.”
Dr. James A. Hayward, president and CEO of Applied DNA, said,
“The clinical successes of CAR T-cell therapy against blood cancers
have been impressive, though limited by the complex production of
viral vectors that are currently needed for T-cell genetic
transformation and the use of pDNA. These manufacturing
complexities have likewise hindered research on CAR T-cell
therapies. As described in the publication, the use of LinearDNA,
coupled with non-viral transfection systems, we believe, overcomes
many of the existing manufacturing complexities associated with
pDNA and viral vectors, thereby offering therapy developers a rapid
and cost-effective tool for manufacturing preclinical CAR T cells.
The authors’ findings as it relates to LinearDNA coincide with the
industry’s growing interest in alternatives to pDNA for CAR T-cell
therapies with approximately 50% of recent CRO orders coming from
CAR T cell developers.”
The detailed study write-up can be found at: Molecular Therapy:
Methods and Clinical Development, the leading journal for research
in the areas of gene transfer, vector development and design, stem
cell manipulation, development of gene-, peptide-, protein-,
oligonucleotide-, and cell-based therapeutics to correct genetic
and acquired diseases, vaccine development, preclinical target
validation, safety/efficacy studies, and clinical trials.
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 the 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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For Applied DNA: 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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