LineaRx Receives Multiple Purchase Orders for Linear DNA for Use in Therapeutic Development
Orders Reflect Growing Interest Across the Biotech Industry for Bacteria-Free, Plasmid-Free Therapies
STONY BROOK, NY. July 1, 2019 – LineaRx, Inc., a wholly-owned subsidiary of Applied DNA Sciences, Inc. (“Applied DNA or the Company,” NASDAQ: APDN), announced today that it has received multiple purchase orders, from several major developers of gene and cell therapies, for its proprietary and patented large-scale, polymerase-chain-reaction (PCR)-produced linear DNA. LineaRx believes this momentum reflects increasing interest across the biotech industry to pursue a cleaner, higher-performing alternative to plasmid DNAs that are produced by fermentation in bacteria.
Under these Phase 1 CRO (Contract Research Organization) agreements, the performance of linear DNA will be benchmarked by criteria such as gene expression, and cell viability, against existing data from DNA produced using plasmids. LineaRx will also optimize, produce, and purify the products as required for testing both in vitro and in vivo by our customers. Upon successful benchmarking, LineaRx expects these customers will proceed to Phase 2 studies that leverage additional LineaRx intellectual property to enhance expression levels or expression lifetimes to drive greater therapeutic performance, while optimizing costs.
“In a number of completed studies, our linear DNA has met or exceeded the performance of plasmid DNA, as measured by gene expression, cell viability, and immunogenicity,” stated Dr. James Hayward, president and CEO of LineaRx. “These new Phase 1 CRO studies will seek to establish the performance of our linear DNA with several significant biotech companies focused on gene and cell therapies, including those focused on adoptive cellular therapies as well as RNA-based therapeutics. This increasing interest that encompasses a broad spectrum of industry players is an early, yet important, endorsement of our view that our proprietary PCR technology offers the potential for improved outcomes relative to current plasmid and viral-vector production technologies.”
To produce the quantities of DNA required for therapeutics, plasmid DNA is grown in bacteria and requires a costly purification process in an attempt to remove bacterial and non-target plasmid DNA, as well as bacterial toxins, before the purified DNA is used. It is commonly known that residual unintended DNA may still be present worrisome concentrations in the final product. LineaRx intends to eliminate the risk associated with the presence of bacterial or unintended plasmid DNA in current therapies via its expertise in the design, manufacture and chemical modification of DNA by large scale PCR.
“We attribute the increase in CRO orders, from marquis companies, to the growing desire to eliminate the risk associated with the presence of bacterial or unintended plasmid DNA in their therapies,” added Hayward. “We expect these CRO projects will evolve to CMO (Contract Manufacturing Organization) orders as some of these customers, once through their pre-clinical work, will bring linear DNA-based therapies to clinical trial within the next 18 months.”
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA Sciences’ 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.
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