Applied DNA Sciences, a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, and Takis Biotech, a company focused on the development of cancer vaccines and founded by scientists from Merck Research Laboratories, announced an expansion of their Covid-19 vaccine development programme to include a fifth vaccine candidate. Production of all vaccine candidates is expected to be completed this month at Applied DNA’s LinearDNA™ production facility in Stony Brook, N.Y. All vaccine candidates have also been approved by Italy’s Ministry of Health for preclinical animal testing that is scheduled to begin in late April 2020.
“The newly added 5th linear DNA vaccine candidate encodes an engineered fusion protein of a COVID-19 Spike domain with an immunomodulator moiety,†indicated Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech, “This additional candidate expands the breath of our study, further increasing the probability that a successor emerges from our preclinical trials.â€Â
Dr. James Hayward, president and CEO of Applied DNA, stated, “With the addition of a fifth candidate, we have more “arrows in our quiver†to enhance our probability of success. The new potential candidate may facilitate a productive immune response, while minimising mechanisms known to have potential negative effects on the infection. Concurrent with the Takis animal trials, Applied DNA will prepare for cGMP production of selected vaccine candidate(s) to support human trials scheduled to begin this fall.â€Â
Under the terms of the companies’ amended Joint Development Agreement, Takis will use the scaled-up LinearDNA synthetic genes produced by Applied DNA for each of the five 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 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 proven in a prior LinearDNA vaccine preclinical study, 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 has been identified to take the coronavirus vaccine to market nor is there any indication that the Company’s applications to develop countermeasures would be approved by regulators.