STONY BROOK, N.Y. & ROME--(BUSINESS WIRE)--Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that it has completed design qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech (“Takis”), a developer of cancer vaccines and the Company’s COVID-19 vaccine development partner, to support preclinical animal testing that will begin immediately. The vaccine candidates were produced by the Company’s proprietary PCR-based LinearDNA™ manufacturing systems.
“Preliminary animal test results from the plasmid-based vaccine templates, from which Applied DNA’s linear DNA-based vaccine constructs were manufactured at scale, were immunogenic and induced a strong production of antibodies across all five vaccine candidates,” said Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech. “Our next step is to utilize these LinearDNA candidates to inoculate mice whose sera will be tested for the presence of antibodies that bind to purified Spike protein. The Spike protein is the most abundant protein on the surface of SARS-CoV-2, the virus that causes the disease, COVID-19, and is the means of binding to and entering into human host cells. Those positive candidates whose antibodies bind to Spike will be tested for their ability to neutralize SARS-CoV-2 by preventing uptake of the virus in cells in culture and in animal models.”
Dr. James Hayward, president and CEO of Applied DNA, stated, “We are very encouraged by the preliminary results from Takis, given the prior close correlation we observed in efficacy between plasmid templates and linear DNA vaccines, and we anticipate similar results from our LinearDNA candidates with the added advantage of lower risk of antibiotic resistance and genome integration often present when circular DNA that is found in plasmids is used. Linear DNA vaccines also holds a significant advantage over plasmids in their speed of production that will be critical to containing this global pandemic. Having shipped the vaccine candidates, we turn our attention to the execution of our cGMP plan to support human trials scheduled to begin this fall. Our focus on Spike in the vaccination process is a natural correlate of our focus on Spike in our diagnostic assay. The abundance of Spike protein on the surface of the virus is a natural consequence of the abundance of Spike RNA in the cytoplasm of infected human cells, greatly enhancing the sensitivity of our RT-qPCR (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 epidemiology, diagnosis and treatment of COVID-19. However, our results must be validated in third-party laboratories where our work will be repeated.”
Applied DNA and Takis make clear that no commercial partner has been identified to take the coronavirus vaccine candidates, nor our diagnostic in development, to market nor is there any indication that the Company’s applications to U.S. Food and Drug Administration or equivalent foreign regulatory agencies would be approved for our vaccine or COVID-19 diagnostic.
About Takis Biotech
Takis is a Biotech Company created by a group of scientists from Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include four Cancer Vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.
Visit www.takisbiotech.it for more information.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
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 fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners product 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, 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 report on Form 10-Q filed on February 6, 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.