LineaRx offers simplified manufacturing path to RNA Biotherapeutics via linear DNA
STONY BROOK N.Y., October 1, 2018 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA), the leader in large-scale PCR-based DNA manufacturing, announced today that LineaRx, Inc. (“LineaRx” ” or the “Company”), its wholly-owned subsidiary focused on next-generation biotherapeutics, has secured multiple new developers of RNA therapeutics as customers for its Contract Research Organization (CRO) services, utilizing large scale production of linear DNA by Polymerase Chain Reaction (PCR). LineaRx provides these clients a faster, safer and less expensive manufacturing approach for these important biotherapeutics as compared to traditional production methods.
As part of its recent formation, LineaRx subsumed the activities of Applied DNA as a CRO and Contract Manufacturing Organization (CMO) to the biotherapeutics market. LineaRx offers prospective customers and development partners with access to a unique portfolio of patented and proprietary linear DNA technologies designed to effectively optimize delivery, improve targeting, and extend expression of cellular and gene therapy products.
“With its extensive experience in the manufacture of nucleic acids, LineaRx is the ideal partner to support growing demand for research activities. We are witnessing a rising number of requests from prospective customers as the industry becomes increasingly cognizant of the Company’s value-adding technology that can improve DNA or RNA therapeutics,” stated Dr. James Hayward, president and CEO of Applied DNA. “Over the next 3 months, LineaRx will provide GLP grade, custom DNA, to a number of customers developing RNA vaccines. We are confident that the results will show LineaRx PCR-produced DNA is well suited for use in the production of RNA therapeutics”.
The RNA-based therapeutic market is rapidly expanding, and is expected to reach $1.2 billion, globally, by year 2020. RNA biotherapeutics include both therapeutics and vaccines and are a relatively new class of drug. When used as a therapeutic, RNA can be utilized for protein production (mRNA based-therapeutics) or in an interfering capacity to inhibit gene expression (antisense/interfering RNA-based therapeutics). This duality of functionality of RNA allows RNA-based therapeutics to target a wide range of indications including cancer, AIDS, rare genetic disorders, neurodegenerative disorders and cardiovascular conditions.
RNA therapeutics are typically manufactured from a DNA template. When done at scale, the DNAs have historically been obtained from the circular, plasmid DNA grown in bacteria. The circular DNA must be precisely nicked to become linear and must be purified to remove all bacterial toxins and bacterial DNA. In contrast, large-scale, PCR-produced linear DNA is now available as a CRO service from LineaRx. PCR methods are used by RNA developers during bench-scale development, so that RNA drug developers are imminently familiar with this form of DNA and are gratified by its availability in large scale from LineaRx.
“Bacteria used to produce the plasmids contain toxins and pyrogens, that can cause illness and fevers if present in the final therapeutic that is delivered to a patient,” commented Dr. Mike Hogan, VP of Life Sciences for Applied DNA. ”The strengths of LineaRx’s PCR products lie not only in our ability to produce them at scale, but also through their purity in containing only the DNA necessary for the targeted therapeutic function.”
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”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial 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 circular DNA are permanent and alter the genomes of the affected cells and their progeny. The fundamental challenge of all gene and cellular therapies is safety. Recent studies have elaborated “unintended consequences” when plasmid and viral vectors are combined that may pose future risks for treated patients.
When linear DNA enters the nucleus, it does not need to be incorporated into the genome to be temporarily expressed as the intended protein product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.
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.
We make 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-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 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.
The Company’s common stock is listed on NASDAQ under the symbol APDN, and its warrants are listed under the symbol APDNW.
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 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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