- Beyond expectations, a single injection of
DNA in mice induced antibodies that block the infection of cultured
human cells by SARS-CoV-2 -
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company” or “we/our”) today announced with its COVID-19 vaccine
development partner Takis Biotech (“Takis”) that the first
injections of the DNA vaccine candidates against the Spike protein
(product of the S gene) of the SARS-CoV-2 virus, cause of the
COVID-19 disease, have produced neutralizing antibodies in test
animals. The studies were completed at the renowned Lazzaro
Spallanzani (“Spallanzani”) National Institute for Infectious
Diseases in Rome. These initial results were obtained using
plasmids (the templates for LinearDNA™) to baseline results;
Applied DNA’s linear DNA dose-response trials begin this week.
The Joint Development Agreement between Takis and the Company
calls for the manufacture of the DNA vaccine candidates for both
preclinical and human trials via Applied DNA’s proprietary and
patented LinearDNA PCR (Polymerase Chain Reaction) platform. This
method of production is enzymatic and yields highly purified DNA,
we believe without the risks of plasmid production in bacteria.
Highly scalable, production can take place in the Company’s
headquarters in Stony Brook or can be disseminated in conventional
pharmaceutical plants available globally. The LinearDNA vaccine
candidates will use the patient as a “temporary bioreactor” to
enable the production of Spike antigens in the patient for a period
of about two weeks, we believe long enough to produce the immune
response necessary to block the infection and the spread of
SARS-CoV-2.
“We are proud of the rapid achievements with our Joint Partners
in the fight to vanquish COVID-19 through its Spike protein and
corresponding gene,” said Dr. James Hayward, CEO of Applied DNA
Sciences. “The candidate vaccine constructs lend themselves to
rapid manufacturing, and the potential for low-dose vaccination
could enhance the power of our platform in a global pandemic, by
requiring less manufacturing to vaccinate a given population size.
Moreover, the simplicity of our joint approach empowers a technical
response to viral mutations within days or weeks. We are especially
aware of the irony of collaborating from New York and Rome, two
locations so badly struck by COVID-19.”
The Spallanzani was engaged from the onset of the pandemic,
having been among the first to obtain and sequence the virus, and
developed unique models for the assessment of vaccines and
convalescent plasma.
Said Dr, Luigi Aurisicchio, CEO and Chief Scientific Officer at
Takis, “Thanks to the Spallanzani's skills, as far as we know, we
are among the first in the world to have demonstrated the
neutralization of the coronavirus by a vaccine. We believe this
will also happen in humans.”
The partners begin dose-response trials with our linear DNA
analogues this week. Discussions have begun with third parties with
an established presence in vaccine distribution, compliance and
marketing. The Company believes that linear DNA vaccines are
especially stable when freeze-dried, helping to assure stability in
global supply chains.
There can be no assurance that the vaccine candidate will be
successfully shown to provide immunity to SARS-CoV-2, that the
vaccine candidate will be approved for use by the U.S. FDA or any
equivalent foreign regulatory agency, that the vaccine candidate
can be manufactured in large quantities or that third parties with
an established presence in vaccine distribution, compliance and
marketing will enter into an agreement with the Company or Takis.
Positive results in animals may not be predictive of human outcomes
after DNA vaccination. In addition, numerous other SARS-CoV-2
vaccines are under development by other third parties, any of which
may be more successful than the Company’s and Takis’ vaccine
candidate and even if the Company’s and Takis’ vaccine candidate is
successful, it may generate only limited revenue and profits for
the Company.
About Takis Biotech, S.R.L.
Takis is a Biotech Company created in November 2009 by a group
of scientists from IRBM, a Research Center in near Rome, formerly
part of the global network of Merck Research Laboratories (MRL).
The group has more than 15 years of experience and an established
track record in drug discovery in Oncology and is recognized for
the conception and implementation of a number of innovative
technologies. One of the main assets of Takis is the expertise in
in vivo electro-gene-transfer, which can be used for a variety of
clinically useful applications, from vaccine development to somatic
gene therapy. Takis pipeline include four Cancer Vaccine candidates
based on this technology. Takis is also actively involved in the
generation of humanized monoclonal antibodies for use in Oncology
and Infectious Diseases.
Visit www.takisbiotech.it for more information.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping, diagnostics and pre-clinical
nucleic acid-based therapeutic drug candidates.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
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 ticker
symbol ‘APDN’, and its publicly traded warrants are listed on OTC
under 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 the possibility
of a failure to make timely payment on its outstanding secured
convertible notes and resulting enforcement by noteholders of
remedies on collateral which includes substantially all of Applied
DNA’s assets, 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 partners therapeutic
candidates will advance further in the preclinical research or
clinical trial process, including receiving clearance from the U.S.
Food and Drug Administration or equivalent foreign regulatory
agencies to conduct clinical trials and whether and when, if at
all, they will receive final approval from the U.S. FDA 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 our Annual Report on Form 10-K filed on December
12, 2019 and our subsequent quarterly report on Form 10-Q filed on
February 6, 2020, and other reports we file 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/20200504005224/en/
investor contact: Sanjay M. Hurry, LHA Investor
Relations, 212-838-3777, shurry@lhai.com program contact:
Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com, https://adnas.com/linearx
twitter: @APDN
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