Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and its program development partner, Evvivax, S.R.L. (“Evvivax”), today announced results from an in vitro neutralization study of sera from the trial cohort comprised of 11 domestic felines vaccinated with the Applied DNA-Evvivax LinearDNA™ COVID-19 vaccine candidate against the B.1.1.7 (U.K.), P1 (Brazil), and B.1.526 (New York) SARS-CoV-2 variants. This study extends the previously announced induction by the vaccine candidate of neutralizing antibodies against functional virus of the D614G lineage and showed that all 11 vaccinated felines produced neutralizing antibody titers against all three variants.
The study showed neutralizing antibody titers against B.1.1.7 were not significantly impacted, while neutralizing antibody titers against P1 and B.1.526 were reduced as expected and consistent with other CDC-reported data on vaccine-induced antibody neutralization against these variants1. The Company believes these expected reductions in viral neutralization titers against P1 and B.1.526 are unlikely to lead to a significant reduction in the effectiveness of the vaccine candidate against these variants in domestic felines and other veterinary applications, such as farmed mink.
“The LinearDNA-based COVID-19 vaccine has a unique molecular design in the face of steadily evolving variants. In targeting the receptor-binding region of SARS-CoV-2 that is crucial for viral entry into host cells, we expect high levels of protection against current and future variants with this vaccine,” said Dr. Luigi Aurisicchio, CEO/CSO of Evvivax S.R.L.
Dr. James A. Hayward, president and CEO of Applied DNA, said, “These data are very encouraging and reinforce our belief that our LinearDNA COVID-19 vaccine candidate will be protective against existing and emerging variants. We plan to initiate a SARS-CoV-2 challenge trial with mink in August of this year where we hope to demonstrate the protective nature of our LinearDNA vaccine candidate against COVID-19 for subsequent commercial application.”
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
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.’
Applied DNA is a member of the Russell Microcap® Index.
Evvivax, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech (www.takisbiotech.it). Evvivax pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on proprietary viral vectors and DNA platform technologies. Evvivax frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. Evvivax aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology. More recently, Evvivax has moved to developing innovative vaccines against zoonotic diseases, including a vaccine against COVID-19 for pets.
Visit www.evvivax.com for more information.
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, 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 partner’s therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA), U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final or conditional approval from the U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown ability to manufacture the vaccine candidates in large quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to generate revenue or profit for Applied DNA, 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 17, 2020 and Quarterly Reports on Form 10-Q filed on February 11, 2021 and May 13, 2021 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.