Agreement Engages Full Scope of Linear DNA Platform; Customer to Evaluate Use of Linear DNA to Potentially Improve Efficacy and Safety of CAR Therapy PipelineSTONY BROOK N.Y., March 20, 2020 – 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.
Common stock listed on NASDAQ under the symbol APDN.
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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