Applied DNA and Evvivax Announce Positive Preliminary Results of Phase I Clinical Trial for LinearDNA COVID-19 Vaccine Candidate in Felines

Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and its program development partner, Evvivax, S.R.L. (“Evvivax”), today announced positive preliminary Phase I clinical trial results for a LinearDNA COVID-19 vaccine candidate (the “vaccine candidate”) in adult domestic felines. Results following administration of a single prime dose of the vaccine candidate on day 1 in late February indicate that the LinearDNA vaccine candidate is well-tolerated by the cohort. A SARS-CoV-2 neutralization assay was conducted by the Cornell University Animal Health Diagnostic Center at the College of Veterinary Medicine 20 days after prime dose delivery to establish the immune response of all cohort members. The results of the neutralization assay yielded high titers of SARS-CoV-2 neutralizing antibodies (NAb) from all cohort members. Follow-on NAb assay results after administration of the vaccine candidate booster are expected to be available in late April 2021. Based on the initial promising NAb titers after a single prime dose of the LinearDNA vaccine candidate, the companies intend to extend the evaluation of neutralizing antibodies in select cohort members through September 2021 to determine the durability of the immune response.

Dr. Diego Diel, D.V.M., M.S., Ph.D., Associate Professor of Virology at the Cornell University College of Veterinary Medicine’s Department of Population Medicine and Diagnostics, who performed the NAb assay, stated, “The levels of neutralizing antibodies elicited in the vaccinated cats after only a single prime dose are compelling. Based on these preliminary data, it seems like this vaccine candidate has the potential to be effective in cats and perhaps other COVID-19-susceptible animals such as ferrets and minks.”

Dr. Joseph Impellizeri, DVM, DACVIM (O), MRCVS, veterinary oncologist at Guardian Veterinary Specialists (GVS) in Brewster, N.Y., and Trial Supervising Investigator for the study, said, “Administration of the vaccine candidate via electroporation was well-tolerated with no adverse events in the normal healthy feline volunteers. Preliminary findings with antibody production at this level are very encouraging and support the continued development of the vaccine candidate.”