Applied DNA Achieves System Milestone in Advancement of Linear DNA Veterinary COVID-19 Vaccine

STONY BROOK, N.Y.–(Enterprise WIRE)–Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based mostly DNA producing, right now introduced that it has experienced a freeze-dried (lyophilized) form of its LinearDNA™ COVID-19 vaccine candidate for its forthcoming feline scientific trial. Lyophilization renders the vaccine candidate shelf-steady and handy to ship globally at room temperature, therefore circumventing a crucial logistical limitation inherent to all present nucleic acid-primarily based (human and veterinary) vaccines. Portions of the lyophilized vaccine candidate were being produced and delivered packaged in vials to its system enhancement spouse, EvviVax, S.R.L. (“EvviVax”) for preclinical efficiency, sterility, and endotoxin tests. Potency checks on the lyophilized vaccine candidate resolubilized with water for use proved that its efficacy in mobile culture matched the potency of the vaccine’s prospect non-lyophilized form. Primarily based on the testing success, the Firm continues to be on monitor to initiate its formerly announced feline COVID-19 vaccine demo by March 31, 2021.

Utilized DNA has manufactured a complete supply of the lyophilized type of the LinearDNA vaccine applicant and has transported a part to EvviVax to oversee a 2nd and remaining round of preclinical screening to be performed by an impartial third-occasion tests laboratory. Upon its successful completion of this spherical of testing, the balance of the lyophilized vaccine prospect will be used to initiate Stage I of the veterinary medical demo.

“Our veterinary vaccine program is a charge- and time-efficient path to commercializing our COVID-19 vaccine improvement operate whilst also serving as a testbed to validate our LinearDNA producing platform for a broad vary of nucleic acid-centered therapeutics,” said Dr. James A. Hayward, president and CEO, Utilized DNA. “These preclinical final results maintain perhaps significant implications for our LinearDNA manufacturing platform for use as an different to plasmid DNA-primarily based production that now forms the basis for all latest nucleic acid-based mostly therapeutics. In specific, we think that a lyophilized linear DNA vaccine would be of major advantage to the pharmaceutical industry’s means to distribute nucleic acid-based mostly vaccines devoid of a chilly chain.”

Concluded Dr. Hayward, “The discovery of SARS-CoV-2 variants in human populations are the immediate consequence of the virus’s evolution in human hosts. We believe that that the virus’s evolution in animals that serve as reservoirs features similar prospects for enhanced physical fitness that could be mitigated by a veterinary vaccine. Domestic animal health and fitness is our end target, nevertheless we are conscious that an efficacious vaccine could have utility in industrial animal well being and, at some point, in human beings. We have by now viewed the virus mutate in farmed mink and bounce back into individuals in Denmark and other countries in Europe and elsewhere.”

Scientific Path for Linear COVID-19 Veterinary Vaccine Prospect

The intention of the medical demo is to assess the vaccine candidate as a technique for the avoidance of SARS-CoV-2, the virus that causes COVID-19, in feline companions of people that may well mitigate the animals as a probable reservoir for bacterial infections in humans. Domestic felines are a recognized COVID-19 reservoir and can transmit the virus to other felines. No transmission back again to human beings has been documented, however the scientific risk remains, presented the virus’s zoonotic origin.

Recruitment of family cats for Period I of the trial has previously discovered a cohort of wholesome domestic feline companion animals that will get two doses of the LinearDNA vaccine prospect and then be adopted for up to six months. The trial’s key endpoint is to exhibit the safety and immunogenicity (detection of neutralizing antibodies and T-mobile reaction) of the vaccine prospect in domestic felines. The vaccine prospect earlier yielded sturdy antibody and T-cell responses even at incredibly reduced doses in mice.

Stage II of the demo, which is at this time underneath growth, would challenge an added cohort of domestic felines in a controlled setting with the LinearDNA vaccine prospect. Upon seroconversion, the vaccinated felines would then be positioned amid an contaminated COVID-19 feline cohort. The fees of transfer of the infection among the the vaccinated cohort will be studied with a prepared endpoint of revealing the vaccine candidate’s over-all efficacy towards energetic sickness.

On the assumption that both equally trials’ key endpoints are achieved, the Organization and EvviVax assume to utilize 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 crisis needs, these types of as the COVID-19 outbreak, and most likely accelerates the vaccine candidate’s time-to-current market.

About Applied DNA Sciences

Applied DNA is a supplier of molecular technologies that empower offer chain protection, anti-counterfeiting and anti-theft technological know-how, item genotyping, and pre-medical nucleic acid-based mostly therapeutic drug candidates.

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Forward-Seeking Statements

The statements produced by Used DNA in this push launch might be “forward-looking” in nature in just the indicating of Area 27A of the Securities Act of 1933, Portion 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-searching statements describe Applied DNA’s long run designs, projections, approaches and anticipations, and are dependent on assumptions and entail a quantity of dangers and uncertainties, numerous of which are outside of the regulate of Utilized DNA. True outcomes could differ materially from those projected because of to, its history of web losses, minimal economic sources, minimal sector acceptance, the uncertainties inherent in research and growth, potential scientific facts and investigation, including no matter whether any of Used DNA’s or its partner’s therapeutic candidates will progress further in the preclinical study or medical demo process, like acquiring clearance from the U.S. Food and Drug Administration (U.S. Food and drug administration), U.S. Division of Agriculture (USDA) or equivalent international regulatory companies to perform scientific trials and no matter whether and when, if at all, they will obtain final approval from the U.S. Food and drug administration, USDA or equal international regulatory agencies, the unknown end result of any apps or requests to U.S. Food and drug administration, USDA or equivalent overseas regulatory companies, the mysterious skill to manufacture the vaccine candidates in substantial portions, the point that the protection and efficacy of the vaccine candidates has not but been recognized, the unidentified means of the vaccine candidates to produce earnings or income for Utilized DNA, the point that there has hardly ever been a commercial drug item utilizing PCR-made DNA know-how authorized for therapeutic use, and many other components in depth from time to time in Utilized DNA’s SEC reports and filings, like our Annual Report on Variety 10-K submitted on December 17, 2020, and other reviews we file with the SEC, which are readily available at Applied DNA undertakes no obligation to update publicly any forward-on the lookout statements to mirror new facts, situations or conditions just after the date hereof or to mirror the incidence of unanticipated situations, except if if not expected by law.