Market Overview

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

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'

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
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.

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