Applied DNA Expands BioPharm Vertical with Two New Research Pilots of DNA Therapeutics

Applied DNA Sciences, Inc., has begun initial Research and Development pilots for the manufacture of DNA for use in DNA-based therapeutics for two companies. Several other companies have requested proposals for additional DNA-based therapeutics. In one project, the Company is engaged in evaluation of a DNA therapeutic with a US-based customer and in the second, the Company is conducting an evaluation of two animal vaccines with Evvivax srl, an Italian biotech company focused on healthcare for companion animals. These pilots will be developed using the Company’s proprietary and patented large-scale PCR (polymerase chain reaction) DNA production processes and devices.

“We are pleased with the technical capabilities and customer service of the Applied DNA team. PCR-production of DNA offers advantages over ‘plasmid produced’ DNA. The goal of this pilot is to quantify those advantages for use in our animal vaccines.”

“We are seeing strong business momentum in our biopharm vertical as awareness of and interest in our proprietary processes and devices for the production of DNA using PCR methods increases, thereby offering us an additional driver of long-term and profitable growth. As our team’s sophistication, breadth of experience and recognition by leading scientists continues to mature, we are fielding pilot requests that are greater in number, financial significance and duration. Recently, we have fielded six new requests for pilot quotation for DNA therapeutics,” commented Dr. James Hayward, president and CEO of Applied DNA.

Dr. Luigi Aurisicchio, Chief Executive and Scientific Officer of Evvivax srl, stated: “We are pleased with the technical capabilities and customer service of the Applied DNA team. PCR-production of DNA offers advantages over ‘plasmid produced’ DNA. The goal of this pilot is to quantify those advantages for use in our animal vaccines.” USDA has already approved a number of DNA-vaccines for animals.

The new pilots complement current agreements to supply PCR-produced DNA to suppliers of diagnostics. The Company’s current customers develop the diagnostic tests, while Applied DNA acts as the long-term supplier of their customized DNA. The Company continues to cultivate opportunities in diagnostics for its PCR-produced DNA that is cleaner, faster, and more easily modified than DNA made from legacy technologies.

This is a natural extension to the Company’s roadmap of DNA-tagging commercial pharmaceutics to secure supply chains of approved drugs. The DNA tags are short, have no biological function by design, and are present as traceable “excipients,” which aid in the manufacture of finished drugs, but are not the Active Pharmaceutic Ingredients (APIs). Now the Company’s portfolio will include (longer) functional DNA therapeutics.

“We have the know-how in place to drive the Company’s new role in the DNA diagnostics and therapeutics market, and the commercial connectivity between the two. Our competencies in PCR enable us to transition from bench to production quickly. Our existing industrial taggant and new biomedical programs complement one another perfectly, steadily improving our capacity to manufacture simple (short) and complex (long) DNA sequences. Our cutting-edge methods to design and detect DNA support all of these markets,” remarked Dr. Mike Hogan, Vice President of Life Sciences for Applied DNA.

DNA vaccines have until now, been based primarily upon “plasmid” delivery. Plasmids are small, circular, double-stranded molecules of DNA found in bacteria and yeast. These molecules have traditionally been the tools used to manufacture DNA. However, a plasmid-based technology for gene therapy suffers from a number of drawbacks that include: a) the active DNA only represents about 30-50% of the plasmid, b) the remaining 50-70% of the plasmid contains multiple genetic components unrelated to the DNA vaccine that may have unintended consequences in humans, c) the plasmid-containing bacteria must be grown in very large vessels, over many days, to yield DNA supplies adequate for vaccines, d) the bacteria used to produce the plasmids contain toxins and pyrogens, that can cause illness and fevers if present in the DNA preparation that is given to a patient.

Dr. Stephen Hughes, Director of DNA Programs, stated: “Our network of contacts includes thought-leaders in industrial biotech, personalized medicine, and the requirements for precision diagnosis, and DNA therapeutics. It is very rewarding to be able to deploy the newest development in our sciences, for benefit in industry and medicine.”

PCR-produced DNA is very pure, especially compared to plasmids. Bacteria are not used during manufacturing. The reaction starting materials are limited to the nucleotides (adenine, thymine, guanine and cytosine) contained within the target sequence, an enzyme called polymerase, the template for the target DNA and primers. Almost all the starting materials are consumed during the reaction. Any residual reactants are easily removed during purification of the target DNA, due especially to the latter’s far greater size. Most importantly, the PCR-produced DNA contains only the DNA elements required for DNA therapeutic function and is free of any of the extraneous genetic elements intrinsic to a plasmid-based carrier.