By GREGORY ZELLER //
Applied DNA Sciences has long proclaimed textiles – your cotton shirt, your leather shoes and the industries that produce them – as its primary vertical market, the ideal sector in which to apply its patented DNA-based security and authentication protocols.
But a wholly different use for its coveted DNA supplies may soon eclipse textile-tracking as the Stony Brook biotech’s primary moneymaker.
That’s the word from President and CEO James Hayward, who on Thursday announced multiple research-and-development pilots involving the manufacture of DNA for use in DNA-based therapeutics – and suggested that biopharma pursuits could one day supplant Applied DNA’s flagship molecular-tracking tech and services as the firm’s No. 1 vertical.
“It would not surprise me,” Hayward told Innovate LI. “Our business model includes using fast-to-market, unregulated industrial applications in large commercial ecosystems, and balancing that with the application of our core science and IP to regulated applications in DNA medicine and diagnostics.”
In English: Yes, Applied DNA can do very well churning out unique DNA strands for research purposes. And churning out unique DNA strands is something of a specialty for the biotech, particularly since its 2015 acquisition of West Virginia’s Vandalia Research, whose core technology facilitates the large-scale production of specific DNA sequences via polymerase chain reaction.
Known best by its stage name, PCR amplifies the tiniest DNA samples, quickly generating billions of copies. With Vandalia in the fold, Applied DNA is an ideal manufacturing partner for the burgeoning biopharma industry.
The pilots announced Thursday will have Applied DNA evaluating DNA therapeutics for Evvivax, an Italian biotech focused on the treatment of companion animals, and an unnamed U.S. customer. Both therapeutics will be developed using Applied DNA’s “proprietary and patented large-scale PCR DNA-production processes and devices,” according to the company.
The deals highlight “strong business momentum in our biopharma vertical,” Hayward noted, “thereby offering us an additional driver of long-term and profitable growth.”
The detour into DNA therapeutics, which Applied DNA termed “a natural extension to the company’s roadmap of DNA-tagging commercial pharmaceutics to secure supply chains,” is not unprecedented. The new pilots complement multiple existing agreements to supply PCR-produced DNA to diagnostics suppliers.
But “awareness of and interest in our proprietary processes and devices for the production of DNA using PCR methods is increasing,” Hayward noted, and the Stony Brook firm is actively cultivating new opportunities in the biopharma realm.
“Several other companies have requested proposals for additional DNA-based therapeutics,” according to Applied DNA, though its CEO envisions a long road before the promising biopharma vertical sits atop the biotech’s revenue mountain.
“I expect we will pursue all of [the requested proposals], but they must accept our quotations,” Hayward said. “That said, we offer such advantages over existing technology that I expect we will win most RFPs.
“There are more than 100 clinical trials just now in [DNA therapeutics],” he added. “And I think we will see several of our projects progress to market.”