Applied DNA Secures Global Top-20 Pharmaceutical Manufacturer as Drug Development Customer
March 20 2020 - 11:29AM
Business Wire
- Agreement Engages Full Scope of Linear DNA
Platform; Customer to Evaluate Use of Linear DNA to Potentially
Improve Efficacy and Safety of CAR Therapy Pipeline -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA”) (the
“Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing for product authenticity, traceability solutions,
nucleic acid-based biotherapeutic development, and liquid biopsies
for cancer diagnostics, announced today that it has signed a
Research Agreement (the “Agreement”) with a global Top-20
pharmaceutical company (the “customer”) to evaluate the full scope
of the Company’s linear DNA platform: linear DNA production as part
of the customer’s improvement strategy for the manufacturing
process of CAR (Chimeric Antigen Receptor) therapy and in
conjunction with their non-viral gene transduction technology, the
research project will include; the Company’s patented technologies
that leverage LifeSensors’ SUMO-fusion technologies to maximize
protein expression as well as, Applied DNA’s unique linear
anti-CD19 CAR-T construct (for treatment of acute lymphocytic
leukemia).
The Agreement is aligned with the customer’s strategy to deploy
technologies to improve the efficacy and safety of its CAR
therapies development pipeline with an emphasis on non-plasmid,
non-viral technologies. Under the terms of the Agreement, the
customer cannot be identified, and the financial terms cannot be
disclosed. However, the contract will be entirely prepaid in
advance.
”This agreement validates our linear DNA platform strategy and
evidences growing interest in our manufacturing platform for the
development of nucleic acid-based therapies and diagnostics from
the highest tier of pharmaceutical manufacturers for applications
that range from CAR-T to RNA vaccines,” stated Dr. James A.
Hayward, president and CEO of Applied DNA. “Whereas interest from
our development customer base to date reflects their increasing
need for an alternative to plasmids as the source of DNA, the
inclusion of an evaluation of our non-viral, plasmid-free LinCART19
CAR-T therapy in this Agreement opens the door for the potential
use of linear DNA in the customer’s CAR-T pipeline as well as the a
potential for sponsorship for our antiCD19 CAR-T. Successful
evaluations across the three components of the Agreement should
lead to a scaling of orders over time to establish a base of
recurring revenue.
“We believe that a faster, cheaper and potentially safer
alternative to plasmids underpins in an entirely new approach to
nucleic acid therapies. LinearDNA™ avoids the potential problems of
plasmid-based therapies, including contamination by bacterial
toxins and other bacterial substances, accidental inclusion of
off-target DNA from the bacteria and plasmids (including the genes
associated with antibiotic resistance), and integration into the
patient genome. As the sole manufacturer of PCR-produced linear DNA
at scale, we believe our platform can be the industry’s sea
change,” concluded Dr. Hayward.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping, diagnostics and pre-clinical
nucleic acid-based therapeutic drug candidates.
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.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list. Common stock listed on NASDAQ
under the symbol APDN.
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 the possibility
of a failure to make timely payment on its outstanding secured
convertible notes and resulting enforcement by noteholders of
remedies on collateral which includes substantially all of Applied
DNA’s assets, its history of net losses, limited financial
resources, limited market acceptance, the fact that there has never
been a commercial drug product utilizing PCR-produced DNA
technology approved for therapeutic use, the uncertainties inherent
in research and development, future clinical data and analysis,
including whether any of Applied DNA’s or its partners product
candidates will advance further in the preclinical research or
clinical trial process, including receiving clearance from the U.S.
Food and Drug Administration or equivalent foreign regulatory
agencies to conduct clinical trials and whether and when, if at
all, they will receive final approval from the U.S. FDA or
equivalent foreign regulatory agencies, the unknown outcome of any
applications to U.S. FDA 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 12, 2019 and our
subsequent quarterly report on Form 10-Q filed on February 6, 2020,
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/20200320005407/en/
investor contact: Sanjay M. Hurry, LHA Investor
Relations, 212-838-3777, shurry@lhai.com program contacts:
Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com twitter: @APDN
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