Applied DNA Launches Initiatives to Expand Awareness of LinearDNA™ Platform as an Alternative to Plasmid DNA for Therapeutic Applications, Revamps LineaRx Website
June 29 2022 - 10:00AM
Business Wire
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in cell-free, enzymatic DNA production, announced the formal
launch of business development initiatives to expand the
biotherapeutics industry’s awareness of the LinearDNA™ platform
(the “platform”) as an alternative to current plasmid-based (pDNA)
production processes used in the manufacture of DNA for advanced
nucleic acid-based therapies. The initiatives, undertaken by
LineaRx, Inc., a Company subsidiary focused on the
commercialization of enzymatically produced DNA, position the
platform as a source of high-fidelity DNA to help empower the rapid
growth of advanced nucleic acid-based therapies. The initiatives
include pre-print and peer-reviewed publications of upcoming
preclinical data reads, presentations at industry conferences,
business development activities related to partnering
opportunities, and a revamp of the LineaRx website.
The Company believes that the platform addresses many of the
issues associated with pDNA’s bacteria-based fermentation
manufacturing process while outperforming pDNA in terms of speed,
purity, flexibility, and scalability. The LinearDNA platform
enzymatically produces a linear form of DNA (‘linDNA’), which the
Company believes is relevant to a broad array of advanced
therapeutic applications. In preclinical studies, linDNA has proven
substitutable for pDNA in numerous nucleic acid-based therapies,
including:
- Therapeutic and prophylactic DNA vaccines;
- DNA templates for in vitro transcription to produce RNA,
including mRNA;
- Adoptive cell therapy manufacturing.
LineaRx is expanding linDNA’s use cases to include:
- Viral vector manufacturing for in vivo and ex vivo gene
editing;
- CRISPR-mediated homology-directed repair;
“We believe that the unprecedented demand for DNA, both for
research and clinical development and for therapeutic
manufacturing, is driving gene and cell therapy developers to seek
out new forms of DNA production that can overcome the inclusion of
antibiotic resistance genes that is becoming a topic of increasing
regulatory scrutiny and solve the industry’s plasmid bottleneck,”
stated Dr. James A. Hayward, president and CEO of Applied DNA and
LineaRx. “LinearDNA is DNA made simple, giving therapy developers
access to large quantities of high-fidelity DNA with the potential
advantages of speed, purity, flexibility, and scalability over
pDNA. The marketplace is ready for us, and we stand ready to
deliver a new generation of DNA to support the next generation of
advanced therapies.”
About LineaRx Formed in 2018 to commercialize its 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.
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
LinkedIn. Join our mailing list.
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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version on businesswire.com: https://www.businesswire.com/news/home/20220629005641/en/
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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