Beyond expectations, a single injection of DNA in mice induced antibodies that block the infection of cultured human cells by SARS-CoV-2
STONY BROOK, N.Y. and Rome, Italy – May 4, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company” or “we/our”) today announced with its COVID-19 vaccine development partner Takis Biotech (“Takis”) that the first injections of the DNA vaccine candidates against the Spike protein (product of the S gene) of the SARS-CoV-2 virus, cause of the COVID-19 disease, have produced neutralizing antibodies in test animals. The studies were completed at the renowned Lazzaro Spallanzani (“Spallanzani”) National Institute for Infectious Diseases in Rome. These initial results were obtained using plasmids (the templates for LinearDNA™) to baseline results; Applied DNA’s linear DNA dose-response trials begin this week.
The Joint Development Agreement between Takis and the Company calls for the manufacture of the DNA vaccine candidates for both preclinical and human trials via Applied DNA’s proprietary and patented LinearDNA PCR (Polymerase Chain Reaction) platform. This method of production is enzymatic and yields highly purified DNA, we believe without the risks of plasmid production in bacteria. Highly scalable, production can take place in the Company’s headquarters in Stony Brook or can be disseminated in conventional pharmaceutical plants available globally. The LinearDNA vaccine candidates will use the patient as a “temporary bioreactor” to enable the production of Spike antigens in the patient for a period of about two weeks, we believe long enough to produce the immune response necessary to block the infection and the spread of SARS-CoV-2.
“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,” said Dr. James Hayward, CEO of Applied DNA Sciences. “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 to vaccinate a given population size. Moreover, the simplicity of our joint approach empowers a technical response to viral mutations within days or weeks. We are especially aware of the irony of collaborating from New York and Rome, two locations so badly struck by COVID-19.”
The Spallanzani was engaged from the onset of the pandemic, having been among the first to obtain and sequence the virus, and developed unique models for the assessment of vaccines and convalescent plasma.
Said Dr, Luigi Aurisicchio, CEO and Chief Scientific Officer at Takis, “Thanks to the Spallanzani’s skills, as far as we know, we are 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.”
The partners begin dose-response trials with our linear DNA analogues this week. Discussions have begun with third parties with an established presence in vaccine distribution, compliance and marketing. The Company believes that linear DNA vaccines are especially stable when freeze-dried, helping to assure stability in global supply chains.
There can be no assurance that the vaccine candidate will be successfully shown to provide immunity to SARS-CoV-2, that the vaccine candidate will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that the 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 vaccines are under development by other third parties, any of which may be more successful than the Company’s and Takis’ vaccine candidate and even if the Company’s and Takis’ vaccine candidate is successful, it may generate only limited revenue and profits for the Company.
About Takis Biotech, S.R.L.
Takis is a Biotech Company created in November 2009 by a group of scientists from IRBM, a Research Center in near Rome, formerly part of the global network of 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 uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners therapeutic 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 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.