Applied DNA Announces Publication of Peer-Reviewed Journal Article Validating Potential Use of linearDNA™ as a New Class of DNA-Based Vaccines
January 05 2023 - 8:45AM
Business Wire
- Company Advances Lipid Nanoparticle
(LNP)-based Delivery System to Potentially Broaden LinearDNA
Platform Commercial Utility -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in PCR-based DNA technologies, today announced the
publication of a peer-reviewed research article in Molecular
Therapy – Methods & Clinical Development. The study, titled ‘A
linear DNA vaccine candidate encoding the SARS-CoV-2 Receptor
Binding Domain elicits protective immunity in domestic cats,’
supports the further development of the Company’s LinearDNA™
platform for the large-scale enzymatic (PCR, polymerase chain
reaction) production of prophylactic and therapeutic
linearDNA™-based vaccines. An initial manuscript detailing the
study’s findings was published in preprint form on bioRxiv in July
2022.
The study demonstrated safety and immunogenicity of a linearDNA
vaccine candidate against SARS-CoV-2 in a cohort of family-owned
felines. Prime-boost vaccinations were administered by
electro-gene-transfer intramuscularly to the cohort, which induced
robust neutralizing antibody titers and cellular immune responses.
The study was performed in conjunction with development partner
EvviVax, S.R.L.
“This peer-reviewed publication supports the innovative work we
and our partners are conducting to advance linearDNA as a potential
new class of human and veterinary therapeutics that combines the
rapid design and manufacturing capabilities akin to mRNA therapies
with the thermostability and relative manufacturing simplicity of
linearDNA. Adding to already robust data supporting the potential
of linearDNA in-hand, this study and others being conducted and
planned make a compelling case for linearDNA as a next-generation,
DNA-based vaccine platform, in addition to its utility in the
manufacture of other nucleic acid-based therapies, such as mRNA and
CAR T therapies,” stated Dr. James A. Hayward, president and CEO of
Applied DNA.
Concurrently, the Company is working to optimize the delivery in
vivo of linearDNA to increase its ease of administration via LNPs
that, if successful, would represent a significant turning point in
increasing the commercial viability of linearDNA. The Company is
currently progressing two LNP-related studies in parallel:
- One, the Company is working with Cornell University College of
Veterinary Medicine to test whether a linearDNA vaccine
encapsulated with an off-the-shelf LNP formulation can elicit a
successful immune response when delivered via intramuscular
injection to an animal model. If successful, it would mark the
first time that LNP-encapsulated linearDNA would be shown to be
immunogenic, thereby potentially opening the door for both
prophylactic and therapeutic LNP-linearDNA veterinary
vaccines;
- Two, the Company is working with a well-respected CDMO on an
optimized LNP formulation for use with linearDNA. The goal of this
study is to identify or develop a cost-effective LNP formulation
that maximizes linearDNA’s immunogenicity in vivo. This study is
currently underway, and early-stage in vitro screening studies have
already been completed.
Concluded Dr. Hayward, “Our development work spanning linearDNA
and LNP targets our first entry into the field of veterinary
medicine, specifically the veterinary immuno-oncology market via a
licensed DNA-based vaccine construct that has previously
demonstrated compelling efficacy in canine models in plasmid form.
We believe that linearDNA is well suited to address veterinary
cancers, a leading disease-related killer of dogs, via a de-risked
development path that minimizes therapy development costs and
timelines while also generating additional data for its potential
application to human health.”
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 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, unknown future demand for
its biotherapeutics products and services, the unknown amount of
revenues and profits that will result from any linearDNA-based
therapeutic, whether any of Applied DNA’s or its customers
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), the U.S.
Department of Agriculture (USDA) or equivalent foreign regulatory
agencies to conduct clinical trials and whether and when, if at
all, they will receive final approval as therapeutic products from
the FDA, the USDA, or equivalent foreign regulatory agencies, 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 its Annual Report on Form 10-K
filed on December 14, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230105005599/en/
Corporate Contacts: 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
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From Apr 2024 to May 2024
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From May 2023 to May 2024