2 March 2020 - Applied DNA Sciences Updates on COVID-19 Collaboration with Takis Biotech, 4 Preclinical LinearDNA™ Vaccine Candidates Designed

Stony Brook and Rome: Applied DNA Sciences Inc. a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, and Takis Biotech ("Takis"), a company focused on the development of cancer vaccines, and founded by scientists from Merck Research Laboratories, has announced that the design of 4 DNA vaccine candidates that will be produced for preclinical animal testing via the Company's proprietary PCR-based DNA manufacturing systems.

The companies' announcement follows their statement on February 7, 2020, to announce an expanded Joint Development Agreement (JDA) between the Company's majority-owned subsidiary, LineaRx, Inc. and Takis Biotech to include the preclinical development of a PCR-produced LinearDNA™ vaccine against COVID-19.

"Since expanding our JDA to include the pursuit of a COVID-19 vaccine, the virus has appeared on almost every continent. We expect delivery of the 4 preclinical constructs from Takis in this month. Within weeks of arrival we expect to immediately scale up PCR-based production of each vaccine candidate and ship them back to Takis who will determine each vaccine's relative abilities to provoke an immune response in vaccinated mice," stated Dr James A. Hayward, president and CEO of Applied DNA and LineaRx.

The two firms have designed 4 preclinical vaccines on the basis of the "Spike" protein structure (the proteins responsible for the "crown" on the virus surface, and from whence its name derives). It is the Spike protein that enables uptake of the coronavirus, by binding to specific receptors on the host cells. One of the 4 candidate vaccines is the entire spike gene; the remaining 3 are variants based upon epitope mapping (identifying the likely antigenic portions of the protein) and assembling the corresponding parts of the 'S' gene into a new synthetic LinearDNA gene, and codon optimization (to ensure the new LinearDNA vaccine genes are efficiently expressed as proteins, once the genes have been delivered to a small percentage of the nuclei of the patient's muscle cells.) Additionally, Applied DNA has proprietary means, which are the subject of pending patent applications, for genetic ensembles that increase the expression, folding efficiency and compartmentalization of proteins that can be built into the putative vaccine constructs if the results obtained in animal studies warrant this consideration.

Continued Dr Hayward, "Our patented and proprietary platform for the production of linear DNA (LinearDNA™) not only empowers rapid development and large-scale production, but we believe it has the potential to yield a safe and effective vaccine with fewer risks than other currently utilized DNA production platforms. As is typical for RNA viruses, coronaviruses mutate at rapid rates that require constant surveillance. We believe that one of the many benefits of PCR-produced LinearDNA is the rapidity at which a putative vaccine can be revised to accommodate mutational drift."

Dr Luigi Aurisicchio, CEO and CSO of Takis Biotech, stated: "Our original collaboration under the JDA on a pan-cancer vaccine that will soon enter trials for the treatment of companion animals has already proven the ability of PCR-produced LinearDNA to induce powerful immune responses in animal models. For the induction of antibodies that can neutralize COVID-19, it is essential to use reliable, effective technologies that can be quickly adapted in the face of shifting pathogens, and we believe that is the advantage that Applied DNA's platform affords us over traditional vaccine development and other modern DNA-based vaccines. This global emergency requires a swift response."

Under the terms of the amended JDA, Takis will use the scaled-up LinearDNA synthetic genes for each of the four putative vaccines to inoculate mice, whose sera will be tested for the presence of antibodies that bind to the purified Spike proteins. Those positive candidates that bind to Spike will be tested for their ability to neutralize COVID-19 by preventing the uptake of the virus in cells in culture and in animal models.

The potential advantages posed by PCR-produced LinearDNA vaccines, as opposed to the circular DNA obtained from more traditional plasmid sources, include the speed of production, the absence of antibiotics and their resistance genes, the purity of the DNA, the simplicity of design, the powerful immunogenicity proved in a prior LinearDNA vaccine, the absence of any bacterial contaminants and the fact that the vaccine gene is effective without insertion into the patient's genome.

Applied DNA and Takis make clear that no commercial partner to take the coronavirus vaccine to market has been identified nor is there any indication that the Company's applications to develop countermeasures would be approved by regulators. 

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