By GREGORY ZELLER //
An ambitious Long Island biotech is reporting exciting progress in a two-front battle against the raging novel coronavirus.
Stony Brook-based Applied DNA Sciences on Tuesday announced that it has applied for FDA approval of its Linea COVID-19 diagnostic kit, which detects SARS-CoV-2 – the novel coronavirus that causes the COVID-19 disease – with same-day results.
The announcement comes one day after Applied DNA and Italian biopharma Takis Biotech said the first test injections of DNA-based vaccine candidates produced in tandem by the two companies “have produced neutralizing antibodies in test animals” – potentially, a giant leap toward a human-ready vaccine.
The vaccine candidates target SARS-CoV-2’s “spike” protein, the most abundant protein on the coronavirus’ surface and its primary means of attaching to and entering human cells.
Completed at the Lazzaro Spallanzani National Institute for Infectious Diseases (parli Italiano?) in Rome, those test injections used plasmids – essentially, blueprints of the vaccine candidates reproduced by Applied DNA’s polymerase chain reaction-based LinearDNA manufacturing system.
Trial runs of the LinearDNA-produced vaccine candidates are scheduled for this week. But with the international partnership – which first formed in 2019 to pursue potential cancer treatments – announcing this step less than three months after recalibrating to target COVID-19, scientists on two continents are already pretty excited, according to Applied DNA Sciences President and CEO James Hayward.
“We are proud of the rapid achievements with our joint partners in the fight to vanquish COVID-19 through its spike protein and corresponding gene,” Hayward said Monday.
Takis Biotech CEO and Chief Scientific Officer Luigi Aurisicchio took it a step further, noting the Spallanzani Institute trials were “among the first in the world to have demonstrated the neutralization of the coronavirus by a vaccine.”
“We believe this will also happen in humans,” Aurisicchio added.
If it does, the proprietary LinearDNA manufacturing system stands ready to quickly reproduce live human vaccines, according to Hayward, who noted the “irony” of companies in New York and Rome – two of the pandemic’s global epicenters – working together on a savior serum.
“The candidate vaccine constructs lend themselves to rapid manufacturing, and the potential for low-dose vaccination could enhance the power of our platform in a global pandemic by requiring less manufacturing,” Hayward added.
Applied DNA followed that bit of spectacular news with Tuesday’s Linea COVID-19 diagnostic kit announcement, including the company’s quest for FDA Emergency Use Authorization.
The diagnostic assay also incorporates PCR-based technology and targets that standout “spike” protein. Built for busy hubs like emergency rooms and clinics, it aligns dozens of gene variants available in the National Center for Biotechnology Information database to detect SARS-CoV-2, promising same-day results and 99.97 percent accuracy.
The assay, which completed pre-FDA application validations with the help of Stony Brook University, currently requires those frontal lobe-scraping nasopharyngeal swabs, but Applied DNA designers are already working up a saliva-based system “to increase the ease of patient sampling.”
While other companies are working up new coronavirus detectors and biopharmas around the globe are racing toward a vaccine, progress on both fronts puts Applied DNA – which notes that even an EUA-approved Linea COVID-19 diagnostic kit “may generate only limited revenue and profits” – in a rare, possibly unique position.
“We believe that Applied DNA is one of the only companies engaged both in the detection of the virus and in its prevention,” the company said Tuesday.