Applied DNA Ships COVID-19 LinearDNA Vaccine Candidates to Italian Development Partner to Begin Preclinical Animal Testing

Applied DNA Sciences Inc. announced that it has completed design qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech (“Takis”), a developer of cancer vaccines and the Company’s COVID-19 vaccine development partner, to support preclinical animal testing that will begin immediately. The vaccine candidates were produced by the Company’s proprietary PCR-based LinearDNA manufacturing systems.

“Preliminary animal test results from the plasmid-based vaccine templates, from which Applied DNA’s linear DNA-based vaccine constructs were manufactured at scale, were immunogenic and induced a strong production of antibodies across all five vaccine candidates,” said Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech. “Our next step is to utilize these LinearDNA candidates to inoculate mice whose sera will be tested for the presence of antibodies that bind to purified Spike protein. The Spike protein is the most abundant protein on the surface of SARS-CoV-2, the virus that causes the disease, COVID-19, and is the means of binding to and entering into human host cells. Those positive candidates whose antibodies bind to Spike will be tested for their ability to neutralize SARS-CoV-2 by preventing uptake of the virus in cells in culture and in animal models.”

Dr. James Hayward, president and CEO of Applied DNA, stated, “We are very encouraged by the preliminary results from Takis, given the prior close correlation we observed in efficacy between plasmid templates and linear DNA vaccines, and we anticipate similar results from our LinearDNA candidates with the added advantage of lower risk of antibiotic resistance and genome integration often present when circular DNA that is found in plasmids is used. Linear DNA vaccines also holds a significant advantage over plasmids in their speed of production that will be critical to containing this global pandemic. Having shipped the vaccine candidates, we turn our attention to the execution of our cGMP plan to support human trials scheduled to begin this fall. Our focus on Spike in the vaccination process is a natural correlate of our focus on Spike in our diagnostic assay. The abundance of Spike protein on the surface of the virus is a natural consequence of the abundance of Spike RNA in the cytoplasm of infected human cells, greatly enhancing the sensitivity of our RT-qPCR (Reverse Transcriptase-quantitative PCR) assay, which is advancing quickly in development. Based on the preliminary results we have obtained with our assay, we believe that its sensitivity may help to lower the false negative rates seen in other assays, that confound epidemiology, diagnosis and treatment of COVID-19.  However, our results must be validated in third-party laboratories where our work will be repeated.”

Applied DNA and Takis make clear that no commercial partner has been identified to take the coronavirus vaccine candidates, nor our diagnostic in development, to market nor is there any indication that the Company’s applications to U.S. Food and Drug Administration or equivalent foreign regulatory agencies would be approved for our vaccine or COVID-19 diagnostic.