- Separately, LineaRx Announces Successful
Expression In Vitro of Vaccine Candidate Encapsulated with Lipid
Nanoparticles -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in cell-free, enzymatic DNA production, today announced the
publication of a manuscript containing data demonstrating that a
linearDNA vaccine successfully elicited neutralizing antibodies and
cellular immunity against SARS-CoV-2. The manuscript, authored by
LineaRx, the Company’s majority-owned biotherapeutics subsidiary,
and LineaRx’s development partner, EvviVax, S.R.L., further
establishes the utility of the LinearDNA ("linDNA) platform as a
large-scale enzymatic production approach to prophylactic and
therapeutic veterinary vaccine applications.
The manuscript, "A Linear DNA Vaccine Candidate Encoding the
SARS-CoV-2 Receptor Binding Domain Elicits Protective Immunity in
Domestic Cats," is available in preprint on bioRxiv and will be
submitted for peer-reviewed publication. It details positive data
showing safety and immunogenicity of a linDNA vaccine candidate
against SARS-CoV-2 in a cohort of family-owned cats. Prime-boost
vaccinations were administered by electro-gene transfer
intramuscularly to the cohort, which induced robust, protective
neutralizing antibodies and cellular immune responses.
Separately, LineaRx announced the successful expression in vitro
of its linDNA SARS-CoV-2 vaccine candidate encapsulated within
lipid nanoparticles (LNP). The linDNA-LNP vaccine, designed and
manufactured at the Company’s Stony Brook, New York facility, will
be used in upcoming in vivo animal studies to assess the
performance of linDNA-LNP vaccines and will inform the final design
of the Company’s lead veterinary asset, a linDNA-LNP canine
lymphoma vaccine candidate.
“Veterinary DNA vaccines are an exciting opportunity for us and
this existing data further substantiates that linDNA is well-suited
and efficacious for animal prophylactic and therapeutic vaccines.
Further, when viewed alongside our positive LNP studies, we believe
that a linDNA-LNP product has the strong potential to offer
enhanced ease of administration and improved clinical outcomes,”
stated Dr. Hayward, president and CEO of Applied DNA and LineaRx.
“These data, together with other data generated by LineaRx over the
past 24 months, have been invaluable in better understanding the
performance of the linDNA platform for vaccine applications and
have guided the design of our canine lymphoma vaccine candidate,
for which we are currently identifying out-licensing animal health
partners should our planned clinical trial meet all endpoints and
gain USDA APHIS conditional approval.”
Added Dr. Luigi Aurisicchio, CEO of Evvivax S.R.L., “The results
of this study confirm the potency of the genetic design and
technology of our vaccines. SARS-CoV-2 is a zoonotic disease and
finding a way to protect pets from infection may contribute to
reduce viral reservoir and spreading. We believe that fully
synthetic, linear DNA is a great platform providing gene therapy
and enhanced vaccine products in short time for the prevention and
the cure of many diseases.”
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, Inc.
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.'
About EvviVax
EvviVax, whose name is derived from Engineered Veterinary
Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech
(www.takisbiotech.it). Evvivax pursues the discovery and
development of innovative Therapeutic Veterinary Cancer Vaccines
based on proprietary viral vectors and DNA platform technologies.
Evvivax frontline candidates are two therapeutic cancer vaccines
for canine tumors: Tel-eVax and Erb-eVax. Evvivax aims at
translating scientific breakthrough achievements in Cancer
Immunotherapy into marketed innovative products in Veterinary and
subsequently in Human Oncology. More recently, Evvivax has moved to
developing innovative vaccines against zoonotic diseases, including
a vaccine against COVID-19 for pets.
Visit www.evvivax.com for more information.
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/20220725005465/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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