17 September 2020 - - US-based DNA manufacturing specialist Applied DNA Sciences, Inc. (NASDAQ: APDN) 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 US Department of Agriculture, the companies said.

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 utilising 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.

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.

Applied DNA and Evvivax will co-sponsor the trial. Applied DNA's participation is approximately USD 100,000, and the company will supply a quantity of the linear DNA vaccine candidate.

Applied DNA's LineaDNA vaccine candidates for COVID-19 have previously demonstrated evidence of production of antibody and T-cell responses at low doses of linear DNA in preclinical mouse models.

The company believes that linear DNA vaccines have inherent advantages over conventional DNA and RNA vaccines: they contain only the desired therapeutic DNA sequence with reduced risk of antibiotic resistance and genomic integration; they hold the advantages of speed and scalability when manufactured by the company's LinearDNA manufacturing platform; they are manufactured at high levels of purity and with very simple means of production; they are much more stable during storage and shipments than RNA-based vaccines which is a practical advantage during a worldwide deployment.

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.

Evvivax, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech.

The company pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on proprietary viral vectors and DNA platform technologies.

Evvivax frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. Evvivax aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology.

More recently, Evvivax has moved to developing innovative vaccines against zoonotic diseases, including a vaccine against COVID-19 for pets. Evvivax is currently seeking investors for further expanding the collaboration with ADNAS and other Institutions.