Applied DNA and Evvivax Announce that LinearDNA™ COVID-19 Vaccine Candidate Booster Yields 5-Fold Average Increase in Neutralizing Antibody Titers in Domestic Felines
Manufactured by an enzyme and without bacteria, LinearDNA vaccine candidate is virus-free, plasmid-free DNA
Vaccine candidate induced neutralizing titers in 100% of trial cohort
Based on positive study results, companies plan to accelerate clinical trial with commercial minks
STONY BROOK, N.Y. & ROME. May 6, 2021. 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 a booster injection delivered 30 days after the prime vaccination elicited an average boost in SARS-CoV-2 neutralizing antibody (NAb) levels (titers) by over 5-fold, with every member of the trial cohort producing NAbs. The antibodies produced by the members of the feline cohort were tested against functional SARS-CoV-2 virus of the D614G lineage. The D614G mutation is present in most variants. Testing showed that neutralizing titers were detected in feline sera with a geometric mean titer for the cohort of 398. The average NAb titer results post-booster exceeded the three- to four-fold enhancement previously predicted by the Company. The Company expects to have cellular immunity data for the feline cohort in the coming weeks.
Dr. James A. Hayward, president and CEO, Applied DNA, said, “These data are very exciting because they are produced with infectious, functional virus. While no direct comparison is possible, we believe the immune response elicited by the feline cohort is competitive with the immune responses elicited by currently authorized COVID-19 vaccines. The LinearDNA vaccine candidate, produced by scalable PCR-based manufacturing, yields an extremely pure product, was freeze-dried, shipped without refrigeration, and contains no excipients. We believe these results hold great promise for the potential of LinearDNA vaccines for COVID-19 and other diseases in animals (cats, dogs, ferret, minks) and humans.”
Based on the positive results, the Company plans to initiate a near-term clinical trial for the LinearDNA vaccine candidate in commercial minks to address the ongoing crises in this industry caused by mink’s susceptibility to COVID-19 (in both farm and wild environs) and their ability to transmit new variants to the human population. The Company is seeking a commercial partner for its go-to-market strategy.
Dr. Luigi Aurisicchio, chief executive officer and chief scientific officer, Evvivax and Takis Biotech, commented, “We are very pleased by the quality of these results and believe that continued development of the vaccine candidate is quite justified. We will continue our collaboration and we are hopeful for success in the marketplace.”
Concluded Dr. Hayward, “The vaccine prime and booster study provides the first proof in a higher-order animal of the functional ability and efficacy of LinearDNA. We believe the data from this clinical trial will clear the path to commerce and the eventual application of a LinearDNA platform for human use.”
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 Form 10-Q filed on February 11, 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.