Benzinga | Nov 15, 2021 11:18AM EST

Applied DNA Subsidiary LineaRx Receives Repeat Orders For LinearDNA, Adds Federally Funded Cancer Research Laboratory As CRO Customer

- Demand for Therapeutic DNA Drives Inquiries for Bulk LinearDNA -

Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, and its majority-owned subsidiary LineaRx, Inc., a manufacturer of LinearDNA(tm) via PCR for nucleic acid therapeutics and diagnostics, today announced the receipt of repeat orders from diagnostic customers and a first Contract Research Organization (CRO) order from a new biotherapeutic customer, a federally funded research and development laboratory focused on cancer research. PCR-produced LinearDNA serves as a pure, fast, and flexible alternative to plasmid DNA (pDNA) in the manufacture of cell and gene therapies (CGTs) and nucleic acid vaccines. CRO orders typically provide a means to evaluate LinearDNA within a customer's preclinical development program.

LineaRx has recorded an uptick in CRO orders for LinearDNA in recent quarters. Although a limited number of CGTs are currently on the market, FDA officials predicted in 2019 that the agency will receive more than 200 investigational new drug applications per year for cell and gene therapies and that by 2025, it expects to have accelerated to 10 to 20 cell and gene therapy approvals per year1. As a result of the COVID-19 pandemic, nucleic acid therapies have also moved to the forefront of biotherapeutic science with the successful deployment of mRNA vaccines against the virus.

Most evaluations of LinearDNA currently center on its use in the development of preclinical CAR T therapies, a use case highlighted in a recently published study that utilized LinearDNA in a non-viral manufacture of CD19-specific CAR T cells2. CRO customers are also evaluating LinearDNA for use in mRNA template manufacture, recombinant adeno-associated virus manufacture, and in vivo expression vectors.

Applied DNA and LineaRx CEO Dr. James A. Hayward stated, "We view CRO orders as a leading indicator of LinearDNA adoption that potentially foreshadows our future role as Contract Development and Manufacturing Organization (CDMO) -- the economics of a CDMO far exceeding those of a CRO -- to a future generation of CGTs and vaccines. As global demand for therapeutic DNA for GCTs and vaccines steadily grows, we believe developers' requirements are increasingly centered on higher quality and more scalable DNA production that surpasses the capacity that can be met by the pDNA industry today. This demand is forcing innovator companies into 'build versus buy' decisions that we believe are tipping in our favor. We are beginning to field inbound interest in LinearDNA today that are magnitudes above what we have experienced historically both in terms of volume and value."

Concluded Dr. Hayward, "We believe the COVID-19 pandemic, increasing interest in CGTs, and nucleic acid vaccines are highlighting the shortcomings of pDNA manufacturing. Having established our DNA expertise over the past 15 years that is backstopped by a strong IP portfolio, and with our current ability to produce LinearDNA at GLP levels soon to be upgraded to an initial cGMP production capacity, we are moving quickly to position LinearDNA as a disruptive force in the market for therapeutic DNA."