On 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, reported 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) (Press release, Applied DNA Sciences, MAR 20, 2020, View Source [SID1234555731]).
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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.