Applied DNA Sciences, Inc. announced the publication of a peer-reviewed research article in Molecular Therapy – Methods & Clinical Development. The study, titled A linear DNA vaccine candidate encoding the SARS-CoV-2 Receptor Binding Domain elicits protective immunity in domestic cats, supports the further development of the Company's LinearDNA™ platform for the large-scale enzymatic (PCR, polymerase chain reaction) production of prophylactic and therapeutic linearDNA™-based vaccines. An initial manuscript detailing the study's findings was published in preprint form on bioRxiv in July 2022.

The study demonstrated safety and immunogenicity of a linearDNA vaccine candidate against SARS-CoV-2 in a cohort of family-owned felines. Prime-boost vaccinations were administered by electro-gene-transfer intramuscularly to the cohort, which induced robust neutralizing antibody titers and cellular immune responses. The study was performed in conjunction with development partner EvviVax, S.R.L. Concurrently, the Company is working to optimize the delivery in vivo of linearDNA to increase its ease of administration via LNPs that, if successful, would represent a significant turning point in increasing the commercial viability of linearDNA.

The Company is currently progressing two LNP-related studies in parallel: One, the Company is working with Cornell University College of Veterinary Medicine to test whether a linearDNA vaccine encapsulated with an off-the-shelf LNP formulation can elicit a successful immune response when delivered via intramuscular injection to an animal model. If successful, it would mark the first time that LNP-encapsulated linearDNA would be shown to be immunogenic, thereby potentially opening the door for both prophylactic and therapeutic LNP-linearDNA veterinary vaccines; Two, the Company is working with a well-respected CDMO on an optimized LNP formulation for use with linearDNA. The goal of this study is to identify or develop a cost-effective LNP formulation that maximizes linearDNA's immunogenicity in vivo.

This study is currently underway, and early-stage in vitro screening studies have already been completed.