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, and Takis Biotech (“Takis”), a company focused on the development of cancer vaccines and founded by scientists from Merck Research Laboratories, today announce an expansion of their COVID-19 vaccine development program to include a fifth vaccine candidate. Production of all vaccine candidates is expected to be completed this month at Applied DNA’s LinearDNA™ production facility in Stony Brook, N.Y. All vaccine candidates have also been approved by Italy’s Ministry of Health for preclinical animal testing that is scheduled to begin in late April 2020.
“The newly added 5th linear DNA vaccine candidate encodes an engineered fusion protein of a COVID-19 Spike domain with an immunomodulator moiety,” indicated Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech, “This additional candidate expands the breath of our study, further increasing the probability that a successor emerges from our preclinical trials.”
Dr. James Hayward, president and CEO of Applied DNA, stated, “With the addition of a fifth candidate, we have more “arrows in our quiver” to enhance our probability of success. The new potential candidate may facilitate a productive immune response, while minimizing mechanisms known to have potential negative effects on the infection. Concurrent with the Takis animal trials, Applied DNA will prepare for cGMP production of selected vaccine candidate(s) to support human trials scheduled to begin this fall.”
Under the terms of the companies’ amended Joint Development Agreement, Takis will use the scaled-up LinearDNA synthetic genes produced by Applied DNA for each of the five putative vaccines to inoculate mice whose sera will be tested for the presence of antibodies that bind to the purified Spike proteins. Those positive candidates that bind to Spike will be tested for their ability to neutralize COVID-19 by preventing uptake of the virus in cells in culture and in animal models.
The potential advantages posed by PCR-produced LinearDNA vaccines, as opposed to the circular DNA obtained from more traditional plasmid sources, include the speed of production, the absence of antibiotics and their resistance genes, the purity of the DNA, the simplicity of design, the powerful immunogenicity proven in a prior LinearDNA vaccine preclinical study, the absence of any bacterial contaminants and the fact that the vaccine gene is effective without insertion into the patient’s genome.
Applied DNA and Takis make clear that no commercial partner has been identified to take the coronavirus vaccine to market nor is there any indication that the Company’s applications to develop countermeasures would be approved by regulators.
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 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.