News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.
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.