LineaRx Secures New RNA Therapeutics Customers for Contract Research Services
LineaRx offers simplified manufacturing path to RNA Biotherapeutics via linear DNA
STONY BROOK N.Y. – 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.[1] 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.”
[1] https://www.alliedmarketresearch.com/press-release/RNA-therapeutics-market-is-expected-to-reach-1-billion-globally-by-2020.html
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 in to be temporarily expressed as the intended proteins product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.
