– Anticipates Linear DNA Dose-Response Preclinical Trial Results in June –
STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #cornavirus–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 provided an update related to the development of linear-DNA form of COVID-19 vaccine candidates with development partner Takis Biotech (“Takis”). Subsequent to the Company’s announcement on May 4, 2020 that first injections of plasmid-based DNA vaccine candidates developed by Takis produced neutralizing antibodies in test animals, linear DNA versions of the vaccine candidates manufactured by Applied DNA began dose-response trials the results of which the Company expects to publish in June 2020.
The companies’ development program utilizes the plasmid-based DNA templates to determine baseline results for the efficacy of the vaccine candidates in preclinical animal models. Based on previous studies with its linear-DNA, Applied DNA anticipates similar results from its linear DNA versions of the vaccine candidates in preclinical animal models with the potential added advantage of reduced risk of antibiotic resistance and genomic integration, and speed of production.
“Our preclinical study with Takis on the linear-DNA form of the vaccine candidates is progressing as planned and we eagerly await the results,” stated Dr. James A. Hayward, President and CEO of Applied DNA. “We believe that our linear DNA approach to vaccines is a novel means of combating emerging pandemics. If found to be as efficacious as the plasmid-based templates, we and Takis will move to engage a third-party to conduct toxicology studies to generate the data necessary for potential human clinical trials of the linear-DNA vaccines. Applied DNA and Takis are working together to contribute to the fight against the deadly COVID-19 pandemic.”
Dr. Luigi Aurisicchio, Chief Executive and Scientific Officer of Takis Biotech, said, “The imminent results of the linear DNA versions of our vaccine candidates are a crucial next milestone in our efforts to meet the threat to global public health posed by COVID-19. We are firm believers in the use of PCR amplicons as an emerging technology for DNA vaccines.”
There can be no assurance that the linear-DNA or plasmid vaccine candidates will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that a vaccine candidate can be manufactured in large quantities or that third parties with an established presence in vaccine distribution, compliance and marketing will enter into an agreement with the Company or Takis. Positive results in animals may not be predictive of human outcomes after DNA vaccination. In addition, numerous other SARS-CoV-2 human vaccines are under development by other third parties and even if one or more of the Company’s and Takis’ vaccine candidates are successful, it may generate only limited revenue and profits for the Company.
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’.
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 therapeutic or diagnostic 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 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, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, 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.