Expanded Joint Development Agreement Serves as
Basis for Preclinical Linear DNA Vaccine; Linear DNA Platform Will
be the Production Framework
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing for product authenticity, traceability solutions,
nucleic acid-based biotherapeutic development, and liquid biopsies
for cancer diagnostics, announced today and in a late-day Investor
Call yesterday, that it has expanded its existing Joint Development
Agreement (JDA) with Takis Biotech to include the preclinical
development of a linear DNA vaccine against 2019-nCoV, the new
coronavirus that originated in Wuhan, China, infecting more than
28,000 and killing hundreds in just weeks. The advantages posed by
PCR-produced linear DNA for this challenge include the speed of
production, the absence of antibiotics and their resistance genes,
the purity of the DNA, the simplicity of design, the powerful
immunogenicity proved in a prior linear DNA vaccine, the absence of
any bacterial contaminants and the fact that the vaccine gene is
effective without insertion into the patient’s genome.
The virus expanded its hosts to humans and has been declared a
public health emergency by the World Health Organization (WHO) and
by the U.S. Department of Health and Human Services (HHS). LineaRx,
Inc. (“LineaRx”) is the majority-owned subsidiary of Applied DNA
focused on the therapeutic and diagnostic applications of the
Company’s large-scale PCR platform that is protected by multiple
issued and pending patents.
“We have a patented and proprietary platform for the production
of linear DNA that empowers rapid development and large-scale
production that we believe will yield a safe and effective vaccine
with fewer risks than other DNA production platforms,” said Dr.
James Hayward, president and CEO of both Applied DNA and LineaRx.
“As is typical for RNA viruses, coronaviruses mutate at rapid rates
that require constant surveillance1. We believe that one of the
many benefits of PCR-produced linear DNA is the rapidity at which a
putative vaccine can be revised to accommodate mutational
drift.”
Dr. Luigi Aurisicchio, CEO/CSO of Takis, stated, “Our
collaboration under the JDA on genetic technologies has already
shown the ability to induce powerful immune responses in animal
models using linear DNA. To induce antibodies that can neutralize
2019-nCoV, it is essential to use reliable, effective technologies,
that can be quickly adapted in the face of shifting pathogens. This
global emergency requires a swift response.”
The companies are also developing a cancer vaccine that has
shown rapid tumor clearance in test animals as reported this last
September. Clinical trials using the
linear DNA form of the cancer vaccine in companion animals are
being planned. The Company has also participated in collaborative
submissions for competitive contracts to develop related genetic
countermeasures to protect American warfighters.
The collaborating teams have already begun the design and
optimization of a synthetic gene that when delivered to muscles,
should enable the temporary production of a designed antigen that
could provoke an immune response against the virus. We expect to
have linear DNA ready for testing within the next 60 to 90 days.
Once the optimized gene is assembled, the Company will produce
quantities of the linear DNA prototype vaccine at large scale for
tests in mice. Prior evidence indicates that genes made of linear
DNA reside only temporarily within the muscle cell nucleus, long
enough to provoke an immune response, and is eventually cleared
without genomic integration.
No commercial partner to take the coronavirus vaccine to market
has been identified, nor is there any indication that the Company’s
applications to develop countermeasures would be approved by
regulators.
- Genomic characterisation and epidemiology of 2019 novel
coronavirus: implications for virus origins and receptor binding.
R.Lu et alia. The Lancet. Published online:
https://doi.org/10.1016/S0140-6736(20)30251-8
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.
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.
Applied DNA makes life real and safe by providing innovative,
molecular-based technology solutions and services that can help
protect products, brands, entire supply chains, and intellectual
property of companies, governments and consumers from theft,
counterfeiting, fraud and diversion.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list. Common stock listed on NASDAQ
under the symbol APDN.
About LineaRx, Inc.
LineaRx seeks to commercialize the biotherapeutic value of
Applied DNA’s deep expertise and experience in the design,
manufacture and chemical modification of DNA by large scale
polymerase chain reaction (“PCR”). Linear DNA is a form of DNA
distinct from the circular form of DNA most commonly produced in
plasmids and grown in bacteria. Plasmids are extrachromosomal DNA
found in bacteria and are associated with the genes for antibiotic
resistance which are often exchanged between bacteria and
consequentially, are seen by many to embody a serious threat to
global health. In addition, many nucleic acid-based therapies also
rely on viral vectors for efficient transfection and expression of
plasmid DNA. These viral vectors carry additional nontrivial risks
and are extremely time consuming and expensive to manufacture. Go
to www.adnas.com for more information on LineaRx and to learn more
about how Applied DNA makes life real and safe. LineaRx is a
majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN)
company.
Visit www.takisbiotech.it 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 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 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/20200207005360/en/
investor: 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 twitter: @APDN
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