Unique PCR-based bulk DNA manufacturing offers
purity, simplicity and speed to developers of DNA-based
therapeutics; company seeing growing interest from market
participants as awareness of proprietary processes increases
Applied DNA Sciences, Inc. (NASDAQ: APDN, “Applied DNA”, “the
Company”), has begun initial Research and Development pilots for
the manufacture of DNA for use in DNA-based therapeutics for two
companies. Several other companies have requested proposals for
additional DNA-based therapeutics. In one project, the Company is
engaged in evaluation of a DNA therapeutic with a US-based customer
and in the second, the Company is conducting an evaluation of two
animal vaccines with Evvivax srl, an Italian biotech company
focused on healthcare for companion animals. These pilots will be
developed using the Company’s proprietary and patented large-scale
PCR (polymerase chain reaction) DNA production processes and
devices.
“We are seeing strong business momentum in our biopharm vertical
as awareness of and interest in our proprietary processes and
devices for the production of DNA using PCR methods increases,
thereby offering us an additional driver of long-term and
profitable growth. As our team’s sophistication, breadth of
experience and recognition by leading scientists continues to
mature, we are fielding pilot requests that are greater in number,
financial significance and duration. Recently, we have fielded six
new requests for pilot quotation for DNA therapeutics,” commented
Dr. James Hayward, president and CEO of Applied DNA.
Dr. Luigi Aurisicchio, Chief Executive and Scientific Officer of
Evvivax srl, stated: “We are pleased with the technical
capabilities and customer service of the Applied DNA team.
PCR-production of DNA offers advantages over 'plasmid produced'
DNA. The goal of this pilot is to quantify those advantages for use
in our animal vaccines.” USDA has already approved a number of
DNA-vaccines for animals.
The new pilots complement current agreements to supply
PCR-produced DNA to suppliers of diagnostics. The Company’s current
customers develop the diagnostic tests, while Applied DNA acts as
the long-term supplier of their customized DNA. The Company
continues to cultivate opportunities in diagnostics for its
PCR-produced DNA that is cleaner, faster, and more easily modified
than DNA made from legacy technologies.
This is a natural extension to the Company’s roadmap of
DNA-tagging commercial pharmaceutics to secure supply chains of
approved drugs. The DNA tags are short, have no biological function
by design, and are present as traceable “excipients,” which aid in
the manufacture of finished drugs, but are not the Active
Pharmaceutic Ingredients (APIs). Now the Company’s portfolio will
include (longer) functional DNA therapeutics.
“We have the know-how in place to drive the Company’s new role
in the DNA diagnostics and therapeutics market, and the commercial
connectivity between the two. Our competencies in PCR enable us to
transition from bench to production quickly. Our existing
industrial taggant and new biomedical programs complement one
another perfectly, steadily improving our capacity to manufacture
simple (short) and complex (long) DNA sequences. Our cutting-edge
methods to design and detect DNA support all of these markets,”
remarked Dr. Mike Hogan, Vice President of Life Sciences for
Applied DNA.
DNA vaccines have until now, been based primarily upon “plasmid”
delivery. Plasmids are small, circular, double-stranded molecules
of DNA found in bacteria and yeast. These molecules have
traditionally been the tools used to manufacture DNA. However, a
plasmid-based technology for gene therapy suffers from a number of
drawbacks that include: a) the active DNA only represents about
30-50% of the plasmid, b) the remaining 50-70% of the plasmid
contains multiple genetic components unrelated to the DNA vaccine
that may have unintended consequences in humans, c) the
plasmid-containing bacteria must be grown in very large vessels,
over many days, to yield DNA supplies adequate for vaccines, d) the
bacteria used to produce the plasmids contain toxins and pyrogens,
that can cause illness and fevers if present in the DNA preparation
that is given to a patient.
Dr. Stephen Hughes, Director of DNA Programs, stated: “Our
network of contacts includes thought-leaders in industrial biotech,
personalized medicine, and the requirements for precision
diagnosis, and DNA therapeutics. It is very rewarding to be able to
deploy the newest development in our sciences, for benefit in
industry and medicine.”
PCR-produced DNA is very pure, especially compared to plasmids.
Bacteria are not used during manufacturing. The reaction starting
materials are limited to the nucleotides (adenine, thymine, guanine
and cytosine) contained within the target sequence, an enzyme
called polymerase, the template for the target DNA and primers.
Almost all the starting materials are consumed during the reaction.
Any residual reactants are easily removed during purification of
the target DNA, due especially to the latter’s far greater size.
Most importantly, the PCR-produced DNA contains only the DNA
elements required for DNA therapeutic function and is free of any
of the extraneous genetic elements intrinsic to a plasmid-based
carrier.
About EvvivaxEVVIVAX is a Biotech company based in Rome,
Italy. EVVIVAX aims at translating scientific breakthrough
achievements in Cancer Immunotherapy into marketed innovative
products in Veterinary and subsequently in Human Oncology.
Veterinary Oncology is an extraordinary growing market opportunity:
one in every four dogs will develop cancer during its lifetime and
this generally kills nearly half of pet dogs over the age ten.
EVVIVAX Cancer Vaccines are based on an Adenoviral vector/DNA
platform technology. EVVIVAX’ frontline candidates are two
therapeutic cancer vaccines for canine tumors: Tel-eVax, targeting
Telomerase (TERT), a key molecule in Oncology. b) Erb-eVax, against
HER2/neu oncogene, a well-known and validated target. The main
cancer types suitable for these immunotherapies are: Lymphomas,
Breast, Osteosarcoma and Transitional cell carcinomas.
EVVIVAX stems from new, European platform technologies, and aims
to offer novel therapeutic avenues to pet cancer patients, with the
strong translational potential to complement current human
Immune-Oncology approaches in the next future.
About Applied DNA SciencesApplied 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.
We make 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-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.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list.
The Company’s common stock is listed on NASDAQ under the symbol
APDN, and its warrants are listed under the symbol APDNW.
Forward Looking StatementsThe statements made by APDN 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 APDN’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 APDN. Actual results could
differ materially from those projected due to our short operating
history, limited financial resources, limited market acceptance,
market competition and various other factors detailed from time to
time in APDN’s SEC reports and filings, including our Annual Report
on Form 10-K filed on December 6, 2016, and our subsequent
quarterly reports on Form 10-Q filed on February 9, 2017, May 11,
2017 and August 10, 2017, 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.
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Applied DNA Sciences, Inc.Investors:LHA Investor
RelationsSanjay M. Hurry,
212-838-3777shurry@lhai.comorMedia:Dian Griesel Int’lCheryl
Schneider, 212-825-3210cschneider@dgicomm.comorProgram:Brian
Viscount, 631-240-8800Executive Director Product
Managementbrian.viscount@adnas.comweb: www.adnas.comtwitter:
@APDN
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