STONY BROOK, NY. April 29, 2019 – LineaRx, Inc. ( the “Company”) a wholly owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today that it has improved expression levels and survival rates of linear DNA constructs delivered without viruses or plasmids to human T cells. In collaboration with Avectas, a cell engineering technology business enabling the manufacture of cell therapies, LineaRx has achieved a greater than four-fold increase in cell survival, and a more than 50% increase in linear gene expression of a model amplicon. Results were presented by Avectas last week at the Cell & Gene Meeting on the Mediterranean, attended by more than 50 companies.
“We expect to achieve expression levels of LinCART19™ that will permit our analysis of tumor kill rates in vitro and in animal models, allowing us to complete our preclinical evaluation of this promising therapy,” said Dr. James Hayward, president and CEO of Applied DNA. “We can now see that therapeutic doses are well within our planned range of numbers of redirected T cells. In addition to the pursuit of our own therapies, we are being increasingly approached by companies who see the value of linear DNA in gene and redirected cell therapies.”
Dr. Michael Maguire, CEO of Avectas said, “This is an exciting example of how Solupore® non-viral cell engineering is being used in a next-generation therapeutic product candidate. Through a simpler cell engineering process, Solupore® technology will improve the efficacy and accessibility of such potentially curative products.”
In October 2018, LineaRx announced an exclusive North American licensing and research services agreement with iCell Gene Therapeutics (“iCell”) for an anti-CD19 CAR T therapy. Leveraging Applied DNA’s expertise in large-scale PCR-based production and chemical modification of DNA, LineaRx will utilize its non-viral, plasmid-free (NVPF) platform to develop and produce expression vectors for CAR T therapies, including its own anti-CD19 CAR T therapy candidate, LinCART19.
As presented at the LineaRx Analyst Day on December 6, 2018, the CAR-T gene construct upon which LinCART19 is based, led to 3 of 3 complete remissions in patients with acute lymphocytic leukemia (ALL) up to 9 months at a very-low-dose in a clinical trial conducted by iCell in China under local regulations. While these promising clinical results provide evidence in the value of the genetic code utilized, the CAR T cells were transfected via a viral vector. LinCART19 will utilize linear DNA transfected by non-viral delivery into T Cells.
The Company recently announced the first anti-CD19 expression in human T cells from a gene construct utilizing linear DNA produced via a scalable PCR manufacturing process. Without the use of viral vectors or plasmids, LineaRx’s NVPF manufacturing platform holds numerous potential advantages over existing viral/plasmid-based CAR T approaches offering the possibility of more efficient, affordable and safer gene therapies for patients.
Avectas is a cell engineering technology business, enabling the manufacture of cell therapies. Avectas’ technology, Solupore®, delivers advanced molecules such as mRNA, proteins and gene editing tools to a range of primary cell types including T cells for immuno-oncology and gene editing applications. Solupore® utilizes a membrane disruptive approach to rapidly deliver advanced molecules to cells. It is a simple, rapid and gentle process that yields superior engineered cells. Solupore® results in improved cell processing times and cell health relative to viral vectors and electroporation, leading to a more cost-effective manufacturing process. Avectas is currently partnering with immuno-oncology and gene editing businesses to deliver their proprietary molecules. Avectas is also seeking therapeutic molecules to in-license as the core of a therapeutic program.
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.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.
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.
Common stock listed on NASDAQ under the symbol APDN, and 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 its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, 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 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA 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.