Applied DNA Provides Update on Linear-DNA COVID-19 Vaccine Candidates Development Program
June 08 2020 - 8:26AM
Business Wire
- Anticipates Linear DNA Dose-Response
Preclinical Trial Results in June -
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing that enables in vitro diagnostics, pre-clinical
nucleic acid-based therapeutic drug candidates, supply chain
security, anti-counterfeiting and anti-theft technology, today
provided an update related to the development of linear-DNA form of
COVID-19 vaccine candidates with development partner Takis Biotech
(“Takis”). Subsequent to the Company’s announcement on May 4, 2020
that first injections of plasmid-based DNA vaccine candidates
developed by Takis produced neutralizing antibodies in test
animals, linear DNA versions of the vaccine candidates manufactured
by Applied DNA began dose-response trials the results of which the
Company expects to publish in June 2020.
The companies’ development program utilizes the plasmid-based
DNA templates to determine baseline results for the efficacy of the
vaccine candidates in preclinical animal models. Based on previous
studies with its linear-DNA, Applied DNA anticipates similar
results from its linear DNA versions of the vaccine candidates in
preclinical animal models with the potential added advantage of
reduced risk of antibiotic resistance and genomic integration, and
speed of production.
“Our preclinical study with Takis on the linear-DNA form of the
vaccine candidates is progressing as planned and we eagerly await
the results,” stated Dr. James A. Hayward, President and CEO of
Applied DNA. “We believe that our linear DNA approach to vaccines
is a novel means of combating emerging pandemics. If found to be as
efficacious as the plasmid-based templates, we and Takis will move
to engage a third-party to conduct toxicology studies to generate
the data necessary for potential human clinical trials of the
linear-DNA vaccines. Applied DNA and Takis are working together to
contribute to the fight against the deadly COVID-19 pandemic.”
Dr. Luigi Aurisicchio, Chief Executive and Scientific Officer of
Takis Biotech, said, “The imminent results of the linear DNA
versions of our vaccine candidates are a crucial next milestone in
our efforts to meet the threat to global public health posed by
COVID-19. We are firm believers in the use of PCR amplicons as an
emerging technology for DNA vaccines.”
There can be no assurance that the linear-DNA or plasmid vaccine
candidates will be approved for use by the U.S. FDA or any
equivalent foreign regulatory agency, that a 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 human
vaccines are under development by other third parties and even if
one or more of the Company’s and Takis’ vaccine candidates are
successful, it may generate only limited revenue and profits for
the Company.
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping, and pre-clinical nucleic acid-based
therapeutic drug candidates.
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
or diagnostic 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, the unknown outcome of any
applications or requests to U.S. FDA or equivalent foreign
regulatory agencies, the unknown limited duration of any Emergency
Use Authorization (EUA) approval from U.S. FDA, disruptions in the
supply of raw materials and supplies, 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 reports on Form 10-Q filed on
February 6, 2020 and May 14, 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/20200608005327/en/
Investor contact: Sanjay M. Hurry, 212-838-3777, LHA
Investor Relations, shurry@lhai.com Program contact:
Brian Viscount, Applied DNA, 631-240-8877,
brian.viscount@adnas.com Web: www.adnas.com
Twitter: @APDN
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