- Data Supports Initiation of First Canine
Clinical Trial by Applied DNA to Advance Canine Lymphoma Cancer
Vaccine Licensed from EvviVax -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in cell-free, enzymatic DNA production, and its program
development partner, EvviVax, S.R.L. ("EvviVax"), today announced
the peer-reviewed publication of preclinical animal data in The
Journal of Experimental & Clinical Cancer Research that
supports the use of Applied DNA’s LinearDNA™ platform to produce
veterinary DNA cancer vaccines. LinearDNA is Applied DNA's
proprietary, large-scale polymerase chain reaction (PCR)-based
manufacturing platform that allows for the large-scale, cell-free
production of high-fidelity DNA sequences.
The paper, titled “Linear DNA Amplicons as a Novel Cancer
Vaccine Strategy” and previously published on the non-refereed,
open-access preprint archive bioRxiv in February 2022, investigated
two LinearDNA therapeutic cancer vaccines that were found to
produce a strong immune and specific antitumoral response in mouse
models using electro-gene-transfer (EGT) as the delivery
method.
Applied DNA has exclusively licensed the anti-telomerase reverse
transcriptase (TERT) cancer vaccine studied in the paper for its
LinearDNA platform for veterinary applications. Based on the
positive data from the paper, Applied DNA intends to initiate an
initial clinical trial for canine B-cell lymphoma in the current
calendar year to validate the TERT cancer vaccine in conjunction
with a lipid nanoparticle-based (LNP) delivery system.
Dr. Luigi Aurisicchio, CEO and chief scientific officer of
Evvivax S.R.L., commented, “Prior clinical trials conducted by
EvviVax using a plasmid DNA and adenovirus vector form of the TERT
vaccine together with the standard of care chemotherapy showed an
increase in the survival of canines with Stage III/IV B cell
lymphoma by almost three-fold, from 37 weeks to 97 weeks. While
clinically successful, our regulatory review was not extended due
to hurdles related to the use of plasmid DNA, particularly as it
relates to antibiotic resistance gene inclusion and manufacturing
challenges in association with the adenovirus vector. We believe
that the LinearDNA platform solves both issues.”
Dr. James A. Hayward, president and CEO of Applied DNA, stated,
“The TERT vaccine is a de-risked approach to growing our veterinary
portfolio to target lymphoma, the #1 cancer in dogs, for which we
believe no vaccine is currently being marketed. Recently launched
chemotherapies also offer the potential opportunity for a
combination therapy approach to increase patient survival times.
Our planned initial clinical trial is being designed to optimize
the TERT vaccine and its delivery to gather data to support a
larger clinical study, the outcome of which we believe will
position the vaccine for a USDA APHIS conditional license
application.”
The publication can be accessed on the Journal of Experimental
& Clinical Research website:
https://jeccr.biomedcentral.com/articles/10.1186/s13046-022-02402-5
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary,
large-scale polymerase chain reaction ("PCR")-based manufacturing
platform that allows for the large-scale cell-free production of
specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in
vitro diagnostics and preclinical nucleic acid-based drug
development and manufacturing market. The platform is used to
manufacture DNA for customers as components of in vitro diagnostic
tests and for preclinical nucleic acid-based drug development in
the fields of adoptive cell therapies (CAR T and TCR T therapies),
DNA vaccines (anti-viral and cancer), RNA therapies, clustered
regularly interspaced short palindromic repeats (CRISPR) based
therapies, and gene therapies.
The LinearDNA platform also has non-biologic applications, such
as supply chain security, anti-counterfeiting and anti-theft
technology. Key end-markets include textiles, pharmaceuticals and
nutraceuticals, and cannabis, among others.
Leveraging its deep expertise in nucleic acid-based
technologies, the Company has also established safeCircle™, a
high-turnkey solution for population-scale COVID-19 testing.
safeCircle is designed to look for infection within defined
populations or communities utilizing high throughput testing
methodologies that increase testing efficiencies and provide for
rapid turn-around-times.
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.'
Applied DNA is a member of the Russell Microcap® Index.
About Evvivax S.R.L.
Evvivax, whose name is derived from Engineered Veterinary
Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech
(www.takisbiotech.it). Evvivax pursues the discovery and
development of innovative Therapeutic Veterinary Cancer Vaccines
based on proprietary viral vectors and nucleic acid platform
technologies. Evvivax frontline candidates are two therapeutic
cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. Evvivax
aims at translating scientific breakthrough achievements in Cancer
Immunotherapy into marketed innovative products in Veterinary and
subsequently in Human Oncology. More recently, Evvivax has moved to
developing innovative vaccines against zoonotic diseases, including
a vaccine against COVID-19 for pets.
Visit www.evvivax.com 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, 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 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/20220606005776/en/
Investor Relations contact: Sanjay M. Hurry,
917-733-5573, sanjay.hurry@adnas.com Program contact: Brian
Viscount, 631-240-8877, brian.viscount@adnas.com Web:
www.adnas.com Twitter: @APDN
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