Trial Redesigned to Accelerate Development of Clinical Path to Potential USDA APHIS Conditional License for Commercial Veterinary Sales
STONY BROOK, N.Y. – November 30, 2020 – 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 industry. Further, mink-linked SARS-CoV-2 virus mutations identified in humans have now spread to at least seven countries. Should our veterinary COVID-19 vaccine gain conditional licensure, we believe it could have significant economic and public utility.”
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.
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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.
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.
Sanjay M. Hurry
Applied DNA Sciences
Applied DNA Sciences