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Applied DNA and Takis Report Positive Preclinical Results from LineaDNA™ Vaccine Candidates for COVID-19

July 17, 2020 Off By BusinessWire

– Demonstrates Evidence of Production of Antibodies and T Cell Responses in Mice: Shows Strong Antibody Responses, Activation of Sustainable T-Cell Responses, Presence of IgG in Lungs –

STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #COVID19–Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that linear-DNA forms of COVID-19 vaccine candidates under development by partner Takis Biotech (“Takis”) and manufactured by the Company yielded strong antibody and T-cell responses even at very low doses of linear DNA, raising the potential of effective dosing empowering global utility.

“We are pleased to report that all five LineaDNA vaccine candidates provoked seroconversion in mice with all animals producing IgG against the SARS-CoV-2 Spike Protein by Day 14 and significantly enhanced responses by Day 38. These results are consistent with IgGs that in prior studies with plasmids were neutralizing in that they prevented the uptake of functional virus by host cells in culture,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “We look forward to supporting further studies by Takis with a goal of entering human trials in early Autumn. We believe no single vaccine will provide the security we need as a global population, and that our LineaDNA vaccines will complement those already marching toward the market.”

Dr. Luigi Aurisicchio, Chief Executive and Scientific Officer of Takis Biotech, said, “Our results are very encouraging, and we have good reason for optimism. We must proceed with toxicology studies and move on to large animal studies as we march toward the clinic. We are now moving to engage third parties to help take us to market on the basis of these encouraging results.”

BALB/c mice received linear DNA at day 1 and a booster vaccination on day 21. All animals demonstrated seroconversion to producing IgG against SARS-CoV-2 Spike Protein already by day 14, and significantly enhanced responses by day 38. (Read more…) Five different candidates of linear synthetic genomic constructs of the S gene that encode for the Spike protein were evaluated. The five constructs were designed for optimal expression in muscle and maximal immunogenicity after vaccination.

Titration studies showed that even at dilutions of 1:50,000, antisera derived from mice vaccinated with linear DNA retained its binding activity. IgGs against SARS-CoV-2 Spike could be readily identified in bronchoalveolar lavage, a wash of the lower respiratory system, suggesting that vaccination in mouse muscle would allow the consequent antibodies to fight the infection in the lower lung.

T-cell responses to the linear vaccines were strongest for the linear construct that contained the sequence corresponding to an abbreviated form of the Spike protein, specifically the portion of Spike that binds to the receptor on human cells that mediates viral uptake into the host’s epithelial cells in the respiratory system. The T-cell response involved both the CD4+ and CD8+ lineages, suggesting that the response may survive long term.

In plasmid format, these same vaccine candidates were the first reported to elicit neutralizing antibodies that prevented uptake of SARS-CoV-2 when human cells in culture were challenged by the functional virus in the presence of the mouse antisera. Similar neutralization studies are scheduled to begin shortly for the antisera produced by the linear DNA constructs.

The companies believe that their collaboration on linear vaccines against the disease COVID-19 offers unique advantages in the development of vaccines, and that no single vaccine will offer a universal solution to the pandemic. Linear DNA vaccines offer a broad array of advantages: stability during storage and shipment, the capacity to manufacture both centrally and locally across the globe, vaccine expression without apparent integration into the patient’s genome, the avoidance of antibiotics, no risk of transference of antibiotic-resistance genes, the avoidance of bacterial vectors, high purity and simplicity of production, and apparent high efficacy. Given the mutational proclivity of SARS-CoV-2, and the synthetic genomic design skills of Takis, Applied DNA could manufacture an improved LineaDNA vaccine within days of obtaining the sequence of a mutant variant that dodged the vaccines targeting the currently dominant variants.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.

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The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.

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Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners vaccine candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown ability to manufacture the vaccine candidates in large quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to generate revenue or profit for Applied DNA, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, the unknown outcome of any applications or requests to U.S. FDA or equivalent foreign regulatory agencies, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020 and May 14, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.