Collaboration with Avectas Leads to Significant
Increase in Transfection; Results Presented at the Cell & Gene
Meeting on the Med Increase Optimism toward Use of Linear DNA in
Cell Therapies including CAR-T Therapy
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.
About Avectas
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.
About LineaRx
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
About Applied DNA Sciences
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.
Visit adnas.com for more information. Follow us on Twitter and
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Common stock listed on NASDAQ under the symbol APDN, and
warrants are listed under the symbol APDNW.
Forward-Looking Statements
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.
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investor contact: Sanjay M. Hurry, LHA Investor
Relations, 212-838-3777, shurry@lhai.comprogram
contact: Brian Viscount, 631-240-8877,
brian.viscount@adnas.com web: www.adnas.com,
www.linearxdna.comtwitter: @APDN, @LineaRxDNA
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