Applied DNA Presenting Linear DNA for Gene Therapy at Boston Immuno-Oncology Summit
High-Expression Amplicons Facilitate Non-Recombinant Gene Therapies. Hold the Potential to Serve as an
Alternative to Plasmids and Viral Vectors.
Applied DNA Sciences Inc., (NASDAQ: APDN, “Applied DNA,”), the leader in large-scale PCR-based DNA manufacturing, will present
a poster entitled “Linear DNA High-Expression Amplicons (HEAs) for Gene Therapy” at the 6th Annual Immuno-Oncology
Summit in Boston at the Seaport World Trade Center, August 28-30, 2018. The Company will exhibit its patent-pending HEA technology
at booth 301, where it will offer its Contract Research and Contract Manufacturing services to Summit attendees. The Summit brings
together a unique and international mix of large and medium pharmaceutical and biotech companies, leading universities and clinical
research institutions, government and national labs, CROs, emerging companies and tool providers with a dedicated focus on
next-generation immunotherapy programs.
The term “linear” in this context refers to the physical form of highly purified DNA as produced by polymerase chain reaction or
PCR, the platform upon which Applied DNA is founded. In contrast, the traditional methods of producing DNA in the larger quantities
required by biotherapeutics have employed plasmids, the extrachromosomal circular DNA found in bacteria. Plasmids are best known as
the DNA form by which the genes for antibiotic resistance are exchanged between bacteria.
A fundamental challenge of gene therapy is the development of safe and effective delivery vectors. Most of the more than 2,600
current clinical trials in gene therapy are virally mediated. However, viral vectors have risks stemming from potential allergic
responses and the consequences of permanent alterations to the cellular genome. Recently, our PCR-produced linear DNA in
high-expression amplicons, demonstrated successful expression both in cell lines in vitro, and in vivo. When linear
DNA enters the nucleus, it does not need to be incorporated into the genome in order to be temporarily expressed as the intended
protein product. In order to elicit the biological response intended by genetic vaccines or genetic immune therapies, transient
expression may be sufficient. “We believe this shift in the therapeutic mechanism can improve the outcome for many gene therapies,”
commented Dr. Stephen Hughes, Director of DNA Programs at Applied DNA.
Linear DNA high-expression amplicons, a product of Applied DNA’s effort in synthetic genomics, have the potential to become a
viable alternative to plasmids and to viral vectors for delivery of the required gene therapy constructs because:
- Synthetic vehicles have lower risks of unwanted immunogenicity than viral vectors,
- Patients should have less pre-existing immunity to a synthetic DNA than would be the case with some
viral delivery systems, thus lessening the risk of allergic response,
- HEAs allow incorporation of long DNA sequences in multi-gene cassettes,
- HEAs are easier to synthesize than viral vectors,
- HEAs contain no bacterial plasmid contaminants or sequences of prokaryotic origin such as the genes
for antibiotic resistance, and,
- HEAs can be used to introduce nucleic acid end-modifications and bioconjugate chemistry (not
generally attainable in plasmids or viral vectors) to facilitate their uptake, stability and expression in cells.
Applied DNA will offer access to a unique portfolio of patented and proprietary technologies, such as those that increase the
expression of therapeutic or endogenous genes and improve the circulating lifetimes and efficiencies of the protein products of
gene therapies. By supplying value-adding technology to existing and new DNA and RNA therapeutics via its HEA technology, Applied
DNA can offer improvements to its customers’ therapeutics.
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 DNA mass production for diagnostics and therapeutics.
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. The proprietary DNA-molecular based “CertainT®” platform can be used to identify,
tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.
SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopyable, security
and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and
apparel, BackTrac™ and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful
track-and-trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators. Applied DNA Sciences is also
engaged in the large-scale production of specific DNA sequences using the polymerase chain reaction.
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Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.
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 our history of losses, limited
financial resources, limited market acceptance, shifting enforcement priorities of US federal laws relating to cannabis, 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 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13,
2018, which are available at www.sec.gov.
APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or
circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.
Investor:
LHA Investor Relations
Sanjay M. Hurry, 212-838-3777
shurry@lhai.com
or
Media:
Dian Griesel Int’l
Cheryl Schneider, 212-825-3210
cschneider@dgicomm.com
or
Program:
Applied DNA Sciences Inc.
Brian Viscount, 631-240-8877
Director, Product Management
web: www.adnas.com
twitter: @APDN
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