Applied DNA Ships COVID-19 LinearDNA™ Vaccine Candidates to Italian Development Partner to Begin Preclinical Animal Testing
April 15 2020 - 6:03AM
Business Wire
- Preliminary Testing of Plasmid-based Vaccine
Templates Shows Strong Immune Responses, Catalyzes Testing of
Linear DNA-based Constructs Set to Begin Immediately -
- RT-qPCR COVID-19 Diagnostic Gaining Promise
-
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing that enables diagnostics, pre-clinical nucleic
acid-based therapeutic drug candidates, supply chain security,
anti-counterfeiting and anti-theft technology, today announced that
it has completed design qualification, production and shipment of
five COVID-19 vaccine candidates to Italy-based Takis Biotech
(“Takis”), a developer of cancer vaccines and the Company’s
COVID-19 vaccine development partner, to support preclinical animal
testing that will begin immediately. The vaccine candidates were
produced by the Company’s proprietary PCR-based LinearDNA™
manufacturing systems.
“Preliminary animal test results from the plasmid-based vaccine
templates, from which Applied DNA’s linear DNA-based vaccine
constructs were manufactured at scale, were immunogenic and induced
a strong production of antibodies across all five vaccine
candidates,” said Dr. Luigi Aurisicchio, CEO and CSO of Takis
Biotech. “Our next step is to utilize these LinearDNA candidates to
inoculate mice whose sera will be tested for the presence of
antibodies that bind to purified Spike protein. The Spike protein
is the most abundant protein on the surface of SARS-CoV-2, the
virus that causes the disease, COVID-19, and is the means of
binding to and entering into human host cells. Those positive
candidates whose antibodies bind to Spike will be tested for their
ability to neutralize SARS-CoV-2 by preventing uptake of the virus
in cells in culture and in animal models.”
Dr. James Hayward, president and CEO of Applied DNA, stated, “We
are very encouraged by the preliminary results from Takis, given
the prior close correlation we observed in efficacy between plasmid
templates and linear DNA vaccines, and we anticipate similar
results from our LinearDNA candidates with the added advantage of
lower risk of antibiotic resistance and genome integration often
present when circular DNA that is found in plasmids is used. Linear
DNA vaccines also holds a significant advantage over plasmids in
their speed of production that will be critical to containing this
global pandemic. Having shipped the vaccine candidates, we turn our
attention to the execution of our cGMP plan to support human trials
scheduled to begin this fall. Our focus on Spike in the vaccination
process is a natural correlate of our focus on Spike in our
diagnostic assay. The abundance of Spike protein on the surface of
the virus is a natural consequence of the abundance of Spike RNA in
the cytoplasm of infected human cells, greatly enhancing the
sensitivity of our RT-qPCR (Reverse Transcriptase-quantitative PCR)
assay, which is advancing quickly in development. Based on the
preliminary results we have obtained with our assay, we believe
that its sensitivity may help to lower the false negative rates
seen in other assays, that confound epidemiology, diagnosis and
treatment of COVID-19. However, our results must be validated in
third-party laboratories where our work will be repeated.”
Applied DNA and Takis make clear that no commercial partner has
been identified to take the coronavirus vaccine candidates, nor our
diagnostic in development, to market nor is there any indication
that the Company’s applications to U.S. Food and Drug
Administration or equivalent foreign regulatory agencies would be
approved for our vaccine or COVID-19 diagnostic.
About Takis Biotech
Takis is a Biotech Company created by a group of scientists from
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 fact that there has never
been a commercial drug product utilizing PCR-produced DNA
technology approved for therapeutic use, the uncertainties inherent
in research and development, future clinical data and analysis,
including whether any of Applied DNA’s or its partners product
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, 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/20200415005314/en/
investors: Sanjay M. Hurry, LHA Investor Relations,
212-838-3777, shurry@lhai.com program: 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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