LineaRx Achieves Higher Expression and Survival Rates in Human T Cells Transfected Non-Virally with Linear DNA

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

STONY BROOK, N.Y.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24apdn&src=ctag" target="_blank"gt;$apdnlt;/agt; lt;a href="https://twitter.com/hashtag/Tcells?src=hash" target="_blank"gt;#Tcellslt;/agt;–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.

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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.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777,
[email protected]
program
contact:  Brian Viscount, 631-240-8877, [email protected] 
web:
www.adnas.com,
www.linearxdna.com
twitter:
@APDN, @LineaRxDNA