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™ 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.”
- Statement from then FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. News release. FDA website. January 15, 2019. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics.
- I. Kastankova, et alia, “Enzymatically produced piggyBac transposon vectors for efficient non-viral manufacturing of CD19-specific CAR T cells,” Mol Ther Methods Clin Dev. 2021 Aug 26;23:119-127. doi: 10.1016/j.omtm.2021.08.006. eCollection 2021 Dec 10
About LineaRx, Inc., and LinearDNA™
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA's deep expertise and experience in the design, manufacture, and chemical modification of DNA by large-scale polymerase chain reaction ("PCR") via its LinearDNA Platform.
The LinearDNA Platform is a proprietary large-scale PCR-based manufacturing platform that allows for the large-scale production of specific high-fidelity DNA sequences. Unlike plasmid-derived DNA, LinearDNA is free of adventitious DNA sequences and can be chemically modified to optimize the DNA for specific applications. The LinearDNA platform is currently being used by customers to manufacture DNA as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats-based (CRISPR) therapies and gene therapies, as well as the Company's COVID-19 veterinary vaccine candidate.
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is grounded in the Company’s deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include Gov/Mil, textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’
Applied DNA is a member of the Russell Microcap® Index.
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, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final or conditional approval from the FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to FDA or equivalent foreign regulatory agencies, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, the unknown ability to manufacture therapeutic grade DNA in large quantities, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, 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 17, 2020 and Form 10-Q filed on February 11, 2021, May 13, 2021 and August 12, 2021 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.