Applied DNA and Takis Biotech/Evvivax to Launch Clinical Trial for Veterinary Use of Linear COVID-19 Vaccine Candidate

Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, preclinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that it and Evvivax, S.R.L., a spin-out of Takis Biotech focused on engineered veterinary immunotherapy and vaccines, are expected to initiate a veterinary clinical trial of one of the Company’s five LineaDNA vaccine candidates upon approval of the clinical plan by the U.S. Department of Agriculture. The goal of the vaccine trial is to evaluate the vaccine candidate as a strategy for the prevention of SARS-CoV-2 (COVID-19) (a zoonotic disease) infections in companion felines of humans. The clinical trial will seek to understand the immune response in cats by utilizing a vaccination strategy of interest in people that could yield valuable data for both cats and humans.

In addition to curbing feline SARS-CoV-2 infections, the vaccine may have a secondary benefit of preventing transfer of the SARS-CoV-2 virus from cats to their human owners. While no such transfer has been formally documented to date, there is still much that is unknown about the disease and its transmission across species. The vaccine trial also serves the additional purpose of generating data on larger animals required as part of the Company’s preclinical development work on its vaccine candidates for potential human development.

Veterinary COVID-19 Trial Design

The clinical trial is a New York State-based, single-center trial that intends to enroll 30 healthy domestic feline companion animals and follow them for six months. The study will evaluate domestic feline immune response, safety, and tolerability of the LineaDNA vaccine candidate, which will be injection once per month at 1mg/month for the first three months of the trial. Dosing will be administered intramuscularly via gene electrotransfer utilizing electroporation technology. The primary endpoint is to determine evidence of antibody and T-cell response in the companion felines.

The trial will take place at Guardian Veterinary Specialists in Brewster, N.Y., under the supervision of Dr. Joseph Impellizeri, DVM, DACVIM (O), MRCVS from Veterinary Oncology Services, LLC (link). Applied DNA and Evvivax will co-sponsor the trial. Applied DNA's participation is approximately $100,000, and the Company will supply a quantity of the linear DNA vaccine candidate.