– Trial Redesigned to Accelerate Development of
Clinical Path to Potential USDA APHIS Conditional License for
Commercial Veterinary Sales –
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the
"Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing, EvviVax, S.R.L. (“EvviVax”), a spin-off of Takis
Biotech with expertise in engineered veterinary cancer
immunotherapy and targeted vaccines, and Veterinary Oncology
Services at Guardian Veterinary Specialists (GVS), a
multi-specialty veterinary hospital, announced the receipt of
approvals from the New York State Department of Agriculture and
Markets and the U.S. Department of Agriculture on an advanced
clinical strategy to conduct a previously reported, New York
State-based, veterinary trial of a lead LinearDNA™ COVID-19 vaccine
candidate. The vaccine candidate is jointly developed by Applied
DNA and EvviVax.
Applied DNA, EvviVax, and GVS also announced a redesign of the
veterinary trial to allow for an acceleration of the lead
candidate’s development path with the end goal of applying for a
U.S. Department of Agriculture Animal and Plant Health Inspection
Service (USDA APHIS) conditional license to enable commercial
veterinary sales for domestic felines.
The goal of the trial remains to evaluate the vaccine candidate
as a strategy for the prevention of SARS-CoV-2, the virus that
causes COVID-19, in feline companions of humans that would mitigate
the animals as a potential reservoir for infections in humans.
Domestic felines are a known COVID-19 reservoir and can transmit
the virus to other felines. No transmission back to humans has been
documented, though the scientific possibility remains given the
virus’s zoonotic origin. The trial will take place at GVS in
Brewster, N.Y., and is expected to begin within the next 90
days.
The trial will now recruit a smaller number of healthy domestic
feline companion animals that will receive two doses of the vaccine
candidate and follow the enrolled cohort for up to six months. The
trial’s primary endpoint is to demonstrate the safety and
immunogenicity (detection of neutralizing antibodies and T-cell
response) of the vaccine candidate in domestic felines. The vaccine
candidate previously yielded strong antibody and T-cell responses
even at very low doses in mice.
Trial Supervising Investigator and Diplomate of the American
College of Veterinary Internal Medicine, Dr. Joseph Impellizeri, of
GVS, stated, “By studying the immune response after immunizing an
important host that resides with human counterparts, we hope to
understand better the potential clinical response against the virus
using a specially designed vaccine and delivery system that may
translate to both human and animal protection.”
Accelerated Development of Clinical Path
The redesigned trial allows for immunologic data to be gathered
faster across a smaller cohort that would also support the
near-concurrent pursuit of a parallel trial (the “proposed trial”)
currently being finalized to advance further data by challenging an
additional cohort in a controlled environment with the lead vaccine
candidate. Upon seroconversion, the vaccinated felines would then
be placed among an infected COVID-19 feline cohort. The rates of
transfer of the infection among the vaccinated cohort will be
studied with a planned endpoint of revealing the vaccine
candidate’s overall efficacy against active disease. The data from
the redesigned and proposed trials may also provide additional
support for requisite toxicology and bio-distribution studies to
potentially initiate human SARS-CoV-2 vaccine candidate trials.
On the assumption that both trials’ primary endpoints are met,
the Company and EvviVax expect to apply for a USDA APHIS
conditional license (9 CFR 102.6) for a LinearDNA COVID-19 vaccine
candidate for domestic felines. Conditional licensure is afforded
to products that meet emergency needs, such as the COVID-19
outbreak, and potentially accelerates the vaccine candidate’s
time-to-market.
“In accelerating our vaccine development program for veterinary
application, we seek to elevate our work with EvviVax in the
emerging field of SARS-CoV-2 susceptibility in animals,” said Dr.
James A. Hayward, president and CEO, Applied DNA. “With the
initiation of the redesigned veterinary trial, we progress towards
potentially commercializing our lead LinearDNA vaccine candidate
for use on domestic felines while also generating valuable
complementary data for potential human COVID-19 vaccine candidate
trials and charting a possible development path to other animals,
such as mink. The virus’s impact on farmed mink populations
globally has been especially devastating and has resulted in the
collapse of Denmark’s $800 million mink fur industry1. Further,
mink-linked SARS-CoV-2 virus mutations identified in humans have
now spread to at least seven countries2. Should our veterinary
COVID-19 vaccine gain conditional licensure, we believe it could
have significant economic and public utility.”
Footnotes:
1
https://www.reuters.com/article/us-health-coronavirus-denmark-mink-farme/it-stops-here-danish-mink-farmer-sees-no-future-after-mass-cull-idUSKBN27L2BN
2
https://amp.theguardian.com/environment/2020/nov/18/covid-19-mink-variants-discovered-in-humans-in-seven-countries
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping, and pre-clinical nucleic acid-based
therapeutic drug candidates.
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.
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 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
12, 2019 and our subsequent quarterly reports on Form 10-Q filed on
February 6, 2020, May 14, 2020 and August 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/20201130005340/en/
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
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