- Promising Results Support Further Development
of LinearDNA as a Next Generation Vaccine Platform -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (‘Applied DNA’ or the
“Company”), a leader in polymerase chain reaction (PCR”)-based
technologies, today announced the publication of a manuscript,
co-authored with international academic and industry scientists,
containing data demonstrating that a LinearDNA™-based vaccine
candidate (the “vaccine candidate”) reduced infectious virus
shedding and was protective against SARS-CoV-2 in a challenge trial
in ferrets. The purpose of the challenge trial was to demonstrate
that LinearDNA-based vaccines can express therapeutic antigens that
can confer protection against infection.
With the publication of these data, the Company’s vaccine
candidate has now demonstrated induction of neutralizing antibodies
and T cell responses against multiple SARS-CoV-2 variants and in
multiple animal models, including mice, cats, and ferrets. The
ferret model for respiratory disease closely mimics the
pathogenesis of human COVID-19, and the receptor for the virus is
similar in structure between humans and ferrets.
Supported by the Company’s recent demonstration that its
LinearDNA constructs can be successfully administered in vivo using
lipid nanoparticles (LNPs) and simple intramuscular injection, the
Company believes that the breadth of data generated supports the
further development of its LinearDNA™ platform to be a
next-generation, host-expressed therapeutic DNA platform relevant
to emergent (new pathogens) and non-emergent diseases (such as
cancer).
The manuscript, titled “A Linear SARS-CoV-2 DNA Vaccine
Candidate Reduces Virus Shedding in Ferrets,” and associated study
were sponsored by LineaRx, the Company’s majority-owned
biotherapeutics subsidiary, and authored by LineaRx veterinary
research collaborators at the Cornell University College of
Veterinary Medicine, longtime LinearDNA development partner
EvviVax, S.R.L., clinical trial administrator Veterinary Oncology
Services, and members of the LineaRx research team. The manuscript
is available in a preprint on bioRxiv and has been separately
submitted for peer-reviewed publication.
As described in the manuscript, prime-boost vaccinations at
different dose levels were administered to a cohort of 25 ferrets
by intramuscular injection immediately followed by co-localized
intramuscular electroporation to enhance the cellular uptake of the
vaccine candidate for enhanced immunogenicity. No side effects or
immune-enhanced disease were observed post-administration. After
seroconversion, the study cohort was challenged with SARS-CoV-2
(5x105 plaque-forming units intranasally). Post-challenge, viral
shedding from the cohort was analyzed. The manuscript data show
that the LinearDNA vaccine elicited both humoral and cellular
immune responses with high titers of protective neutralizing
antibodies, and, most importantly, it significantly reduced the
shedding of infectious SARS-CoV-2 through oral and nasal secretions
in the cohort.
Of note, the highest neutralizing titer and levels of reduced
viral shedding were found in animals that received the lowest DNA
dose. This suggests that a prime-boost regimen might be more
critical to induce neutralizing antibodies than a highly
concentrated dose of the vaccine. In addition, like the response
elicited by live attenuated viruses, LinearDNA engaged the major
histocompatibility pathways (MHC-I and MHC-II), including CD8+ and
CD4+ T cells.
“These challenge data represent a major milestone in the
commercialization of our LinearDNA platform. We have proven that a
PCR-produced LinearDNA vaccine can be protective against live virus
and reduce viral shedding, lessening the opportunities for the
disease to spread,” stated Dr. James A. Hayward, president and CEO
of Applied DNA and LineaRx. “Nearly one dozen vaccine platforms
against COVID-19 have been approved by the World Health
Organization (WHO). Continued global preparedness against the next
pandemic will require choosing among the best platforms based on
effectiveness, versatility, stability in distribution, ease of
manufacture, expense, and rapidity of design against new pathogens.
LinearDNA, we believe, meets these requirements while
simultaneously solving many of the challenges associated with
plasmid DNA. LinearDNA has broad applications, from research and
development and drug discovery to precision medicines benefitting
one patient at a time and for large-scale manufacturing for
clinical and commercial use. We are one step closer to our
LinearDNA platform serving as a common denominator for the next
generation of genetic medicines.”
Stated Dr. Diego Diel, Associate Professor of Virology at the
Cornell University College of Veterinary Medicine's Department of
Population Medicine and Diagnostics, “The results of the study
demonstrate the efficacy of the platform for vaccine delivery in
animals, which underscores the potential of the platform for
infectious disease prevention in veterinary medicine.”
Dr. Luigi Aurisicchio, CEO of Takis Biotech and EvviVax, added,
“The data we have generated makes clear that a deep knowledge of
the target disease biology and an appropriate molecular design,
when coupled with the LinearDNA platform, can offer an immediate
solution for infectious diseases as well as cancer. The veterinary
market could immediately benefit from a LinearDNA approach to
vaccine development while concurrently providing new knowledge for
translation to human applications. We are strongly committed to
making these next-generation vaccines available.”
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, 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 the therapeutic grade DNA 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 August 11, 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/20220926005474/en/
Investor Relations Contact: Sanjay M. Hurry,
917-733-5573, sanjay.hurry@adnas.com LineaRx Program
Contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
Web: www.adnas.com Twitter: @APDN
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