Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the
“Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing, and its program development partner, Evvivax, S.R.L.
(“Evvivax”), today announced results from an in vitro
neutralization study of sera from the trial cohort comprised of 11
domestic felines vaccinated with the Applied DNA-Evvivax LinearDNA™
COVID-19 vaccine candidate against the B.1.1.7 (U.K.), P1 (Brazil),
and B.1.526 (New York) SARS-CoV-2 variants. This study extends the
previously announced induction by the vaccine candidate of
neutralizing antibodies against functional virus of the D614G
lineage and showed that all 11 vaccinated felines produced
neutralizing antibody titers against all three variants.
The study showed neutralizing antibody titers against B.1.1.7
were not significantly impacted, while neutralizing antibody titers
against P1 and B.1.526 were reduced as expected and consistent with
other CDC-reported data on vaccine-induced antibody neutralization
against these variants1. The Company believes these expected
reductions in viral neutralization titers against P1 and B.1.526
are unlikely to lead to a significant reduction in the
effectiveness of the vaccine candidate against these variants in
domestic felines and other veterinary applications, such as farmed
mink.
“The LinearDNA-based COVID-19 vaccine has a unique molecular
design in the face of steadily evolving variants. In targeting the
receptor-binding region of SARS-CoV-2 that is crucial for viral
entry into host cells, we expect high levels of protection against
current and future variants with this vaccine,” said Dr. Luigi
Aurisicchio, CEO/CSO of Evvivax S.R.L.
Dr. James A. Hayward, president and CEO of Applied DNA, said,
“These data are very encouraging and reinforce our belief that our
LinearDNA COVID-19 vaccine candidate will be protective against
existing and emerging variants. We plan to initiate a SARS-CoV-2
challenge trial with mink in August of this year where we hope to
demonstrate the protective nature of our LinearDNA vaccine
candidate against COVID-19 for subsequent commercial
application.”
Footnote:
1https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fcases-updates%2Fvariant-surveillance%2Fvariant-info.html
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 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 therapies),
DNA vaccines (anti-viral and cancer), RNA therapies, clustered
regularly interspaced short palindromic repeats (CRISPR) based
therapies, and gene therapies. Applied DNA has also established a
COVID-19 diagnostic and testing offering that is in the early
stages of commercialization and is grounded in the Company’s deep
expertise in DNA.
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.
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.’
Applied DNA is a member of the Russell Microcap® Index.
About Evvivax
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 DNA 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 (U.S. FDA),
U.S. 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 U.S. FDA, USDA or equivalent foreign regulatory agencies,
the unknown outcome of any applications or requests to U.S. FDA,
USDA or equivalent foreign regulatory agencies, the unknown ability
to manufacture the vaccine candidates in large quantities, the fact
that the safety and efficacy of the vaccine candidates has not yet
been established, the unknown ability of the vaccine candidates to
generate revenue or profit for Applied DNA, 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
17, 2020 and Quarterly Reports on Form 10-Q filed on February 11,
2021 and May 13, 2021 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/20210607005313/en/
For Applied DNA: Investor 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
For Evvivax: Corporate/Investor contact: Luigi
Aurisicchio, Evvivax, +39-0650576077, aurisicchio@evvivax.com
Program contact: Antonella Conforti, +39-0650576077,
conforti@evvivax.com Web: www.evvivax.com LinkedIn:
Evvivax
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