Applied DNA Sciences (APDN) Announces LineaRx Achieves Higher Expression, Survival Rates in Human T Cells Transfected Non-Virally with Linear DNA
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April 29, 2019 9:16 AM EDT
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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.
