By GREGORY ZELLER //

With scientists around the world racing toward a COVID-19 vaccine, serums manufactured by a Long Island biotech are showing significant promise – both medically and economically.

Stony Brook-based Applied DNA Sciences and its lab partner, Italian innovator Takis Biotech, said this week that five linear-DNA based COVID-19 vaccine candidates developed by Takis and manufactured by Applied DNA “yielded strong antibody and T-cell responses” in laboratory mice, even at “very low doses” – suggesting “effective dosing empowering global utility.”

Translation: The vaccine candidates are not only effective against COVID-19, but it doesn’t take much of the stuff to get the immunoglobulins flowing – meaning more of it to go around, should it ever be mass-produced for human consumption.

James Hayward: There can’t be only one.

There’s a lot of science between here and there. And the international partners, who first teamed up to target cancer but soon focused Applied DNA’s proprietary linear-DNA technology on COVID-19, are hardly boasting of a global-pandemic cure.

Applied DNA President and CEO James Hayward, in fact, is quick to note that “no single vaccine will provide the security we need as a global population.”

But the five “LineaDNA vaccine candidates” hit their marks in all inoculated test animals, triggering “seroconversion” that produced immunoglobulins against the COVID-19 spike protein. And they did so at super-low doses – test mice that received a LineaDNA shot on Day 1 and a booster vaccination on Day 21 “demonstrated seroconversion” by Day 14, with “significantly enhanced responses by Day 38,” according to Applied DNA.

That’s all good stuff, from both scientific and socioeconomic perspectives, according to Hayward, who predicts human trials of the five LineaDNA vaccine candidates by this fall and a commercialization path that parallels other global research, instead of racing against it.

“These results are consistent with [immunoglobulins] that, in prior studies with plasmids … prevented the uptake of functional virus by host cells in culture,” Hayward said. “We believe our LineaDNA vaccines will complement those already marching toward the market.”

The key is Applied DNA’s proprietary polymerase chain reaction-based DNA manufacturing technology, which enables in vitro diagnostics and a host of other pre-clinical and clinical research possibilities. Selling linear DNA to researchers has quickly become the No. 1 vertical for the global supply-chain authenticator, which spun off subsidiary LineaRX in 2018 to capitalize on the PCR tech – essentially, it produces unique DNA strands of varying sizes – and spun directly into Takis.

Luigi Aurisicchio: Optimism earned.

The Italian biopharma initially saw LineaDNA as an ideal tool for its cancer-research programs. Now, with studies showing that blood serums (even heavily diluted serums) derived from the respiratory systems of LineaDNA-vaccinated mice proving rich with antibodies built to fight the novel coronavirus, “we have very good reason for optimism” on the COVID-19 front, according to Takis Biotech CEO and Chief Science Officer Luigi Aurisicchio.

“Our results are very encouraging,” Aurisicchio said. “We must proceed with toxicology studies and move on to large animal studies as we march toward the clinic.”

Meanwhile, the Stony Brook- and Rome-based partners are initiating dialogues with potential partners capable of delivering the LineaDNA-based vaccines to global markets, when (and if) the time comes.

“We are now moving to engage third parties to help take us to market, on the basis of these encouraging results,” Aurisicchio added.

 



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