Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that it has qualified a freeze-dried (lyophilized) form of its LinearDNA™ COVID-19 vaccine candidate for its upcoming feline clinical trial. Lyophilization renders the vaccine candidate shelf-stable and convenient to ship globally at room temperature, thereby circumventing a key logistical limitation inherent to all existing nucleic acid-based (human and veterinary) vaccines. Quantities of the lyophilized vaccine candidate were manufactured and shipped packaged in vials to its program development partner, EvviVax, S.R.L. (“EvviVax”) for preclinical potency, sterility, and endotoxin testing. Potency tests on the lyophilized vaccine candidate resolubilized with water for use proved that its efficacy in cell culture matched the potency of the vaccine’s candidate non-lyophilized form. Based on the testing results, the Company remains on track to initiate its previously announced feline COVID-19 vaccine trial by March 31, 2021.
Applied DNA has manufactured a complete supply of the lyophilized form of the LinearDNA vaccine candidate and has shipped a portion to EvviVax to oversee a second and final round of preclinical testing to be conducted by an independent third-party testing laboratory. Upon its successful completion of this round of testing, the balance of the lyophilized vaccine candidate will be utilized to initiate Phase I of the veterinary clinical trial.
“Our veterinary vaccine program is a cost- and time-efficient path to commercializing our COVID-19 vaccine development work while also serving as a testbed to validate our LinearDNA manufacturing platform for a wide range of nucleic acid-based therapeutics,” said Dr. James A. Hayward, president and CEO, Applied DNA. “These preclinical results hold potentially significant implications for our LinearDNA manufacturing platform for use as an alternative to plasmid DNA-based manufacturing that currently forms the basis for all current nucleic acid-based therapeutics. In particular, we believe that a lyophilized linear DNA vaccine would be of significant benefit to the pharmaceutical industry’s ability to distribute nucleic acid-based vaccines without a cold chain.”
Concluded Dr. Hayward, “The discovery of SARS-CoV-2 variants in human populations are the direct consequence of the virus’s evolution in human hosts. We believe that the virus’s evolution in animals that serve as reservoirs offers similar opportunities for improved fitness that could be mitigated by a veterinary vaccine. Domestic animal health is our end goal, though we are mindful that an efficacious vaccine could have utility in commercial animal health and, eventually, in humans. We have already seen the virus mutate in farmed mink and jump back into humans in Denmark and other countries in Europe and elsewhere.”
Clinical Path for Linear COVID-19 Veterinary Vaccine Candidate
The goal of the clinical trial is 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 may 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.
Recruitment of family cats for Phase I of the trial has already identified a cohort of healthy domestic feline companion animals that will receive two doses of the LinearDNA vaccine candidate and then be followed 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.
Phase II of the trial, which is currently under development, would challenge an additional cohort of domestic felines in a controlled environment with the LinearDNA 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.
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 the 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.
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 17, 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.
Program contact: Brian Viscount, Applied DNA Sciences, 631-240-8877, email@example.com