19 September 2018 - - US-based PCR-based DNA manufacturing specialist Applied DNA Sciences Inc. (NASDAQ: APDN) has formed LineaRx, Inc., a wholly owned subsidiary, the company said.

Its purpose is to commercialise the company's extensive experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction in the field of biotherapeutics, specifically gene and cellular therapies as well as vaccines.

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.

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.

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.

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.

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.