Applied DNA Biotherapeutics Subsidiary Reports LinearDNA™ Platform Development Milestone: First Successful Administration of LinearDNA In Vivo via Lipid Nanoparticles (LNP)
August 10 2022 - 9:30AM
Business Wire
– Use of LNP Simplifies Administration of
LinearDNA-based Therapies, Potentially Enabling Their Application
in Large Scale –
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in PCR-based DNA technologies, today announced that LineaRx,
the Company’s majority-owned biotherapeutics subsidiary, has for
the first time successfully administered and expressed a
linearDNA-LNP construct in mice via routine intramuscular (IM)
injection without the concurrent use of electroporation (EP) that
utilizes electrical pulses to deliver DNA to target cells. The
Company believes that the removal of the concurrent use of EP
during administration potentially increases the commercial
viability of LinearDNA-based therapies.
IM administered mRNA vaccines delivered via LNPs have altered
the course of the COVID-19 pandemic. Using similar LNP technology,
LineaRx has achieved expression in mice of a linearDNA-LNP
construct encoding reporter proteins via simple IM injection.
Unlike previous LinearDNA animal studies, concurrent EP was not
utilized. The linearDNA-LNP construct used in the successful study
was developed and manufactured by Applied DNA.
Based on LineaRx’s previous successes in the expression of
various DNA constructs, including its therapeutic anti-lymphoma
vaccine, CD123, and its epitope-optimized Spike gene from
SARS-CoV-2, the Company believes that linearDNA-LNP constructs hold
the potential to be used across a wide variety of therapeutic
applications. Near term, LineaRx is working to formulate its canine
lymphoma vaccine candidate for IM administration via LNP.
“Key members of our team have career histories working with
lipidic delivery systems, including at very large scale, so LNPs
are a natural extension of that work,” said Dr. James Hayward,
president and CEO of Applied DNA Sciences and LineaRx. “We are
pleased by the promise of today’s announcement, which supports our
goal to develop LNP-based delivery of LinearDNA-based constructs
for multiple therapeutic applications.”
About LineaRx, Inc.
LineaRx, an Applied DNA Sciences, Inc. (NASDAQ: APDN) company,
was formed in 2018 to commercialize the parent company's 20+ years
of experience in polymerase chain reaction ('PCR')-based DNA
manufacturing and leadership in enzymatic DNA production.
LineaRx is developing and commercializing the LinearDNA™
platform as a cell-free enzymatic platform for the large-scale DNA
manufacture of high-fidelity DNA sequences for use in nucleic
acid-based therapeutics.
DNA manufactured via the platform is free of adventitious DNA
sequences and can be chemically modified to optimize DNA for
specific applications, offering compelling advantages over plasmid
DNA in many biotherapeutic applications, from mRNA and DNA vaccines
to redirected cell and gene therapies.
To learn more about LinearDNA™: click here
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing
technologies to produce and detect deoxyribonucleic acid ("DNA").
Using the polymerase chain reaction ("PCR") to enable both the
production and detection of DNA, we operate in three primary
business markets: (i) the manufacture of DNA for use in nucleic
acid-based therapeutics; (ii) the detection of DNA in molecular
diagnostics testing services; and (iii) the manufacture and
detection of DNA for industrial supply chain security services.
Visit adnas.com for more information. Follow us on Twitter and
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The Company's common stock is listed on NASDAQ under the ticker
symbol 'APDN,' and its publicly traded warrants are listed on OTC
under the ticker symbol 'APPDW.'
Forward-Looking Statements
The statements made by Applied DNA in this press release may be
"forward-looking" in nature within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform 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
or its partner's therapeutic candidates will advance further in the
preclinical research or clinical trial process, including receiving
clearance from the U.S. Food and Drug Administration (FDA), United
State Department of Agriculture (USDA) or equivalent foreign
regulatory agencies to conduct clinical trials and whether and
when, if at all, they will receive final or conditional approval
from the FDA, USDA or equivalent foreign regulatory agencies, the
unknown outcome of any applications or requests to FDA, USDA or
equivalent foreign regulatory agencies, whether results from
preclinical studies will be predictive of the results of later
preclinical studies and clinical trials, the unknown ability to
manufacture therapeutic grade DNA via PCR in large quantities, the
fact that there has never been a commercial drug product utilizing
PCR-produced DNA technology approved for therapeutic use, 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 9, 2021, its Quarterly Report on Form 10-Q filed
on February 10, 2022 and May 12, 2022, and other reports it files
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 or to reflect the occurrence of unanticipated
events, unless otherwise required by law.
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Investor Relations contact: Sanjay M. Hurry,
917-733-5573, sanjay.hurry@adnas.com Program contact: Brian
Viscount, 631-240-8877, brian.viscount@adnas.com Web:
www.adnas.com Twitter: @APDN
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