LI biotech speeds COVID-19 vaccine candidates to Italy

Cure bet: If vaccine candidates prepared by Applied DNA's LinearDNA manufacturing system perform as well as plasmid-based candidates prepared by Italian biopharma Takis Biopharma, the cross-Atlantic collaboration may be on to something.

With preliminary lab tests looking good, an innovative Long Island biotech is rushing a quintet of potential COVID-19 vaccines overseas.

Stony Brook-based Applied DNA Sciences announced Wednesday that it has completed “design qualifications” and shipped five COVID-19 vaccine candidates to Italian biopharma Takis Biotech, a frequent collaborator working closely with Applied DNA to counter the coronavirus.

The vaccine candidates were produced using the Stony Brook biotech’s proprietary, polymerase chain reaction-based LinearDNA manufacturing system, which factored heavily in the two companies’ previous forays into cancer research.

Now, LineaRX – Applied DNA’s linear DNA-focused 2018 spinoff – is knee-deep in the global pandemic, churning out five vaccine candidates scheduled for immediate preclinical animal testing in Italy.

Luigi Aurisicchio: Positive thinking.

It’s fast work for a partnership that only announced its COVID-19 pivot nine weeks ago, expanding an existing Joint Development Agreement and building on Applied DNA and Takis’ prior cancer research.

But speed is essential, with the novel coronavirus continuing its global march, related worldwide deaths surpassing 130,000 and economic calamities mounting. And speed is the whole point of the Applied DNA/Takis partnership, which hopes vaccines produced by the Italian biopharma via older, plasmid-based sciences can be rapidly – and more safely – reproduced by the Stony Brook biotech.

Takis Biotech CEO Luigi Aurisicchio said Wednesday his Rome-based laboratories would waste no time inoculating mice specimen with the LinearDNA-produced vaccine candidates.

Researchers will then check mouse blood samples for antibodies that bind to purified “spike” protein – the most abundant protein on the surface of SARS-CoV-2 (the virus that causes the COVID-19 disease) and the virus’ primary means of attaching to and entering human cells.

“Those positive candidates whose antibodies bind to [spike protein] will be tested for their ability to neutralize SARS-CoV-2,” Aurisicchio said in a statement – and Takis researchers do expect to find some positives.

Aurisicchio noted that preliminary animal tests using plasmid-based vaccine templates produced by Takis “induced a strong production of antibodies across all five vaccine candidates.”

The next step is to see if any of the “vaccine constructs” manufactured by the LinearDNA system can knock out COVID-19 by binding with the spike protein and “preventing uptake of the virus in cells in culture and in animal models,” Aurisicchio added.

Noting an established “close correlation” between the efficacy of plasmid templates and the efficacy of vaccines produced through linear-DNA technology, Applied DNA Sciences President and CEO James Hayward said scientists on both side of the Atlantic Ocean were “very encouraged by the preliminary results” of Takis’ antibody research.

James Hayward: Repeat after me.

“We anticipate similar results from our LinearDNA candidates,” Hayward said Wednesday, citing a number of potential fringe benefits – including a lower risk of antibiotic resistance, a frequent side effect of the “circular DNA” found in plasmids.

“LinearDNA vaccines also hold a significant advantage over plasmids in their speed of production, which will be critical to containing this global pandemic,” Hayward added.

Both Takis and Applied DNA stressed that no coronavirus vaccine candidate has officially been named and no commercial partners have officially been identified. And human trials of any potential vaccines, according to the partners, couldn’t take place until autumn at the earliest.

But the vaccine candidates being prepared by Applied DNA and Takis Biotech appear to combine the right technologies at the right time, according to Hayward, who noted a natural correlation between the project’s focus on spike proteins and the importance of spike proteins to Applied DNA’s Reverse Transcriptase-quantitative PCR assay, “which is advancing quickly in development.”

“Based on the preliminary results we have obtained with our assay, we believe that its sensitivity may help to lower the false-negative rates seen in other assays that confound … diagnosis and treatment of COVID-19,” Hayward added. “However, our results must be validated in third-party laboratories, where our work will be repeated.”