- Manufactured by an enzyme and without
bacteria, LinearDNA vaccine candidate is virus-free, plasmid-free
DNA -
- Vaccine candidate induced neutralizing titers
in 100% of trial cohort -
- Based on positive study results, companies
plan to accelerate clinical trial with commercial minks -
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 a booster injection delivered 30 days
after the prime vaccination elicited an average boost in SARS-CoV-2
neutralizing antibody (NAb) levels (titers) by over 5-fold, with
every member of the trial cohort producing NAbs. The antibodies
produced by the members of the feline cohort were tested against
functional SARS-CoV-2 virus of the D614G lineage. The D614G
mutation is present in most variants. Testing showed that
neutralizing titers were detected in feline sera with a geometric
mean titer for the cohort of 398. The average NAb titer results
post-booster exceeded the three- to four-fold enhancement
previously predicted by the Company. The Company expects to have
cellular immunity data for the feline cohort in the coming
weeks.
Dr. James A. Hayward, president and CEO, Applied DNA, said,
“These data are very exciting because they are produced with
infectious, functional virus. While no direct comparison is
possible, we believe the immune response elicited by the feline
cohort is competitive with the immune responses elicited by
currently authorized COVID-19 vaccines. The LinearDNA vaccine
candidate, produced by scalable PCR-based manufacturing, yields an
extremely pure product, was freeze-dried, shipped without
refrigeration, and contains no excipients. We believe these results
hold great promise for the potential of LinearDNA vaccines for
COVID-19 and other diseases in animals (cats, dogs, ferret, minks)
and humans.”
Based on the positive results, the Company plans to initiate a
near-term clinical trial for the LinearDNA vaccine candidate in
commercial minks to address the ongoing crises in this industry
caused by mink’s susceptibility to COVID-19 (in both farm and wild
environs) and their ability to transmit new variants to the human
population. The Company is seeking a commercial partner for its
go-to-market strategy.
Dr. Luigi Aurisicchio, chief executive officer and chief
scientific officer, Evvivax and Takis Biotech, commented, “We are
very pleased by the quality of these results and believe that
continued development of the vaccine candidate is quite justified.
We will continue our collaboration and we are hopeful for success
in the marketplace.”
Concluded Dr. Hayward, “The vaccine prime and booster study
provides the first proof in a higher-order animal of the functional
ability and efficacy of LinearDNA. We believe the data from this
clinical trial will clear the path to commerce and the eventual
application of a LinearDNA platform for human use.”
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 Form 10-Q filed on February 11, 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/20210506005654/en/
For Applied DNA: Investor contact: Sanjay M.
Hurry, Applied DNA Sciences, 917-733-5573, sanjay.hurry@adnas.com
Program contact: Brian Viscount Applied DNA Sciences,
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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