Applied DNA Forms Wholly Owned Subsidiary, LineaRx, to Develop Large-Scale, PCR-Produced DNA for Biotherapeutics

The Company believes that the opportunity and markets for these biotherapeutics are substantial, and that its proprietary PCR technology offers the potential for improved outcomes relative to current plasmid and viral vector production technologies.

“We believe the launch of LineaRx will unlock significant value to the benefit of Applied DNA shareholders and to the world of healthcare. Our proprietary and patented approach to linear DNA manufacturing holds the promise to deliver more efficient, affordable and safer genetic therapeutics to a broad patient population,” said Dr. James Hayward, president and CEO of Applied DNA. “Unlike Applied DNA’s taggant business, in which the DNA is short and nonfunctional by design, LineaRx DNA sequences are long (gene-sized) and contain the control elements that allow their expression in cells after specialized delivery to the cells. The segregation between the divisions enables the companies to differentiate their product portfolios, business units, operations and regulatory affairs.”

The name LineaRx is derived from the Latin “linea” for “line,” and the symbol Rx, interpreted as “medicine” or “therapy.” “LineaRx” reflects that distinct form of DNA that results from PCR production for use in medicine. Such “linear DNA” is a form of DNA distinct from the circular form of DNA most commonly produced as plasmids that are grown in bacteria. The Company believes the addressable biotherapeutic markets for LineaRx include:

1) gene therapy (more than 2,600 clinical trials globally today; global cell and gene therapy market projected to reach $12 billion by 2020¹);
2) immuno-oncology (expected to grow to $3.8 billion by 2022²); and,
3) DNA vaccines (expected to reach $2.7 billion by 2019³).”

Most gene therapies are based on plasmids, which are the extrachromosomal DNA found in bacteria. Plasmids are associated with the genes for antibiotic resistance, which can make their use risky. In addition, many non-linear DNA-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial genetic risks and are extremely time consuming and expensive to manufacture.

In all forms of gene therapy, DNA exerts its influence from within the nucleus. Recombinant events for viral delivery of plasmid DNA are permanent and alter the genomes of the affected cells and their progeny. In contrast, when linear DNA enters the nucleus, it does not need to be integrated into the genome to be temporarily expressed as the intended protein product. The Company believes that the non-recombinant nature of linear DNA based gene therapies will increase patient safety and therapeutic efficacy and will also ease the regulatory burdens associated with gene therapies.

Applied DNA will license multiple patents for therapeutic applications to LineaRx. These patents include the rights to manufacture DNA via PCR, using Applied DNA’s proprietary and patented systems under cGMP conditions, including the capacity for remote control, that would allow rapid manufacture in a distributed network that could even include the battlefield, or within hospitals that practice gene therapies such as CRISPR or cellular therapies such as CAR T.

The Company believes the simplicity of manufacturing linear DNA via PCR, the ability to chemically modify linear DNA, the absence of bacterial contaminants, the elimination of the requirement for simultaneous manufacture of viral vectors, and the proximity to patients and the trained physicians and nurses required to deliver these therapies, may represent significant time savings that are valuable to successful patient outcomes for linear DNA-based therapies.

Dr. Clint Rubin, Director of the Center for Biotechnology at Stony Brook University stated: “LineaRx broadens the options for developers of gene and cellular therapies. Gene therapies without recombination are a great approach when it is possible to achieve therapeutic goals. The management of LineaRx are experienced pros and bring a much needed and timely asset to the biotech industry, fueling regional and NYS growth in bioscience technology development and commercialization.”

LineaRx will also subsume the current activities of Applied DNA as a Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO) to the biotherapeutics market. “By segregating our markets, and differentiating our sales teams, we expect to be able to better focus our selling efforts,” continued Dr. Hayward. “LineaRx will provide prospective customers and development partners access to a unique portfolio of patented and proprietary linear DNA technologies designed to effectively optimize delivery, improve targeting, and extend expression of gene therapy products. By supplying value-adding technology to existing and new DNA and RNA therapeutics, LineaRx can offer improvements to its customers’ therapeutics.”

Over the past year, the Company has shipped >8,000 milligrams of PCR-produced linear DNA for use in Diagnostic and Therapeutic applications, and has completed, or is progressing through, key milestones of a growing number of therapeutics research contracts for companies producing DNA and RNA vaccines and adoptive cell therapies. Key milestones of success for these gene therapies are delivery of DNA effectively into a cell, expressing the gene product from that DNA and eventually demonstrating the desired clinical outcome.

Through these collaborative efforts, we have shown that linear DNA is effective in expression of genes in vivo. This accomplishment is among the first in which a linear DNA expression amplicon produced by PCR has demonstrated expression in vivo.

¹ https://www.statista.com/statistics/687229/global-cell-and-gene-therapy-market-size/
² Frost & Sullivan
³ https://www.bccresearch.com/market-research/biotechnology/dna-vaccines-bio067b.html

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics and therapeutics.

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. The proprietary DNA-molecular based “CertainT^®” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products. SigNature^® DNA describes the core technology ingredient that is at the heart of a family of what we believe are uncopyable security and authentication solutions such as SigNature^® T and fiberTyping^®, targeted toward textiles and apparel, BackTrac™ and DNAnet^®, for anti-theft and loss prevention, and digitalDNA^®, providing powerful track-and-trace. All provide a forensic chain of evidence and can be used to prosecute perpetrators. Applied DNA Sciences is also engaged in the large-scale production of specific DNA sequences using the polymerase chain reaction.

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Our common stock is listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation 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 our history of losses, limited financial resources, limited market acceptance, shifting enforcement priorities of US federal laws relating to cannabis, 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 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

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