Novel DNA Manufacturing Platform Seeks to
Pioneer New Generation of Faster, More Affordable Cell-based
Therapeutics for Patients
Applied DNA Sciences, Inc. (NASDAQ:APDN) announced today that
LineaRx, (the “Company”), its subsidiary focused on next-generation
biotherapeutics, has achieved anti-CD-19 CAR (Chimeric Antigen
Receptor) expression in human T Cells via its proprietary,
non-viral, plasmid-free (NVPF) manufacturing platform. To the
Company’s knowledge, this seminal event represents the first time
that a human T cell has been shown to express an anti-CD19 CAR from
a gene construct utilizing linear DNA produced via a scalable PCR
(Polymerase Chain Reaction) manufacturing process. The Company
views this development as an important option for all gene
therapies that currently use virus-delivery platforms, but
especially for immune-oncology therapies that use virus delivery of
synthetic genes to redirect a patient’s T cells, known as CAR
therapy.
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Expression of PCR-generated Green
Fluorescent Protein (GFP) gene fragment in hundreds of human T
cells. Image: Applied DNA Sciences
LineaRx’s unique PCR-based manufacturing technology created the
linear DNA amplicon encoding the anti-CD19 engager, and that
construct was then electroporated into human T cells ex vivo.
Subsequent testing has yielded anti-CD19 expression from these
engineered cells. While these preliminary data are encouraging,
overall levels of expression were initially low and LineaRx
continues working on generating higher transfection levels using
the patent-pending High Expression Amplicon (HEA™) and methods of
transfection other than electroporation and will report further
progress on this significant achievement as it emerges.
Dr. James A. Hayward, president and CEO of Applied DNA, stated:
“Our goals are three-fold: 1) To establish the value of
PCR-produced linear DNA as a platform for the rapid design and
production of therapeutic nucleic acid constructs, including at the
point of care; 2) To prove the improved safety and therapeutic
value of NVPF production streams, which are distinct from
industry-wide viral-based production; and, 3) To bring our
NVPF-based anti-CD19 CAR T cell therapy to the clinic with a future
partner.
This accomplishment builds upon another first instance of
engineering human T cells via a linear DNA amplicon produced,
designed and manufactured via LineaRx’s PCR technology in late
2018. The first instance demonstrated a linear DNA amplicon that
contained the complete gene that encoded production of Green
Fluorescent Protein (GFP). As seen in the microscope image above,
the uptake and subsequent expression of the PCR-generated GFP gene
fragment in hundreds of human T cells, facilitated by
high-throughput electroporation, created a “constellation” of green
fluorescent cells.
In October 2018, LineaRx announced the signing of an exclusive
North American licensing and research services agreement with iCell
Gene Therapeutics 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 NVPF
platform to develop and produce expression vectors for CAR T
therapies, including for LinCART19™, its non-viral, plasmid-free
anti-CD19 CAR T drug candidate.
As discussed at the LinearRx Analyst Day in December 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) at 6 months after a single low-dose treatment in a clinical
trial conducted 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 viral
vector. LinCART19 will utilize linear DNA transfected by either
electroporation, soluporation, or other mode of delivery into T
Cells.
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.
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.
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.
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Common stock listed on NASDAQ under the symbol APDN, and
warrants are listed under the symbol APDNW.
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.
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program contact:Brian
Viscount631-240-8877brian.viscount@adnas.com
investor contact:Sanjay M. HurryLHA Investor
Relations212-838-3777shurry@lhai.com
web: www.adnas.com, www.linearxdna.comtwitter:
@APDN, @LineaRxDNA
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