3 March 2021 - - US-based DNA manufacturing company Applied DNA Sciences, Inc. (NASDAQ: APDN) and its program development partner, Italy-based Evvivax, S.R.L., have initiated Phase I of a two-phase clinical trial to evaluate a LinearDNA COVID-19 vaccine candidate for the feline veterinary market, the companies said.

The goal of the 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.

If successful, the clinical trial will also serve as an important initial validation of LinearDNA, Applied DNA's large-scale, PCR-based manufacturing platform, for vaccines.

The clinical trial utilizes a PCR-produced LinearDNA COVID-19 vaccine candidate initially developed by Applied DNA and Takis Biotech, the parent company of Evvivax, for human use.

The human vaccine candidate yielded strong antibody and T-cell responses at low doses of LinearDNA in mouse models.

If the veterinary vaccine candidate demonstrates effectiveness against active disease in cats, the two companies intend to apply for a A Animal and Plant Health Inspection Service (APHIS) conditional license (9 CFR 102.6) to enable commercial veterinary sales for domestic felines.

The American Veterinary Medical Association lists approximately 58.4m cats living in households in the United States in 20181.

Phase I initiation follows the completion of a second and final round of preclinical testing overseen by Evvivax at an independent third-party testing laboratory on a lyophilized (freeze-dried) form of the vaccine candidate administered in the clinical trial.

Phase I is being conducted in Brewster, N.Y. by Veterinary Oncology Services at Guardian Veterinary Specialists, a multi-specialty veterinary hospital, with a primary endpoint of demonstrating the safety and immunogenicity (detection of neutralizing antibodies and T-cell response) of the vaccine candidate in negative, client-owned felines.

On the assumption that the Phase I endpoint is met, Applied DNA and Evvivax are expected to initiate Phase II that will involve the placement of seroconverted vaccinated non-client-owned cats among infected cats, with the primary endpoint being the percent of vaccinated cats that resist infection.

On the assumption that primary endpoints of the two Phases of the clinical trial are met, Applied DNA and Evvivax are expected to apply for APHIS conditional license.

Applied DNA is commercializing LinearDNA, its proprietary, large-scale polymerase chain reaction-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market.

The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies.

Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the company's deep expertise in DNA.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include, textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

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

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