Applied DNA Positions LinearDNA Platform as the Next Generation Manufacturing Platform for Adeno-Associated Virus-based Gene Therapies Through New Patent Filing

Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that it has filed a nonprovisional patent application with the United States Patent and Trademark Office (USPTO) entitled “Methods and Systems of PCR-Based Recombinant Adeno-Associated Virus (AAV) Manufacture” (the “Patent”). The Patent claims priority to a previously filed provisional patent application filed with the USPTO in August of 2019.

AAV is utilized to deliver a therapeutic gene of interest to a patient or a patient’s cells to cause the expression of the necessary protein to address a targeted disease. Reflective of its potential as one of the most promising delivery vehicles for genetic medicines, there are approximately 80 active or enrolling clinical trials that utilize AAV¹. With its new patent application, Applied DNA seeks to leverage its LinearDNA platform to give gene and redirected cell therapy developers the ability to greatly improve the manufacture and quality of their AAV-vectored medicines that have the potential to address many diseases, including COVID-19.

“AAV is generally accepted as the preferred vector for gene therapy, and so, has an enormous breadth as a therapeutic gene delivery system. AAV vectors are manufactured utilizing multiple plasmid DNAs as starting materials, and as the number of gene therapy programs increase, and with improving levels of clinical success and progression of therapies into late-phase clinical studies, the field is being challenged by the need for larger manufacturing scales,” said Dr. James A. Hayward, president and CEO of Applied DNA Sciences. “At Applied DNA, we believe we have solved the linear DNA production challenge and can make the DNA sequences at scale for gene therapies. Utilizing our LinearDNA platform to manufacture amplicons, we can deliver gene therapy constructs that potentially lower the risks that come with the use of plasmid-based AAV manufacture. As one of the only companies in the marketplace commercializing a scaled linear DNA manufacturing platform, we believe we are uniquely positioned to deliver linear DNA as an alternative to plasmids, and with this patent filing, we expand our addressable market to including AAVs.”