APDN Announces Positive Preclinical Data for Cancer Vaccine

Applied DNA Sciences, Inc. (NASDAQ: APDN), a leader in cell-free, enzymatic DNA production, and its program development partner, EvviVax, S.R.L. (“EvviVax”), today announced the peer-reviewed publication of preclinical animal data in The Journal of Experimental & Clinical Cancer Research that supports the use of Applied DNA’s LinearDNA™ platform to produce veterinary DNA cancer vaccines. LinearDNA is Applied DNA’s proprietary, large-scale polymerase chain reaction (PCR)-based manufacturing platform that allows for the large-scale, cell-free production of high-fidelity DNA sequences.

The paper, titled “Linear DNA Amplicons as a Novel Cancer Vaccine Strategy” and previously published on the non-refereed, open-access preprint archive bioRxiv in February 2022, investigated two LinearDNA therapeutic cancer vaccines that were found to produce a strong immune and specific antitumoral response in mouse models using electro-gene-transfer (EGT) as the delivery method.Applied DNA has exclusively licensed the anti-telomerase reverse transcriptase (TERT) cancer vaccine studied in the paper for its LinearDNA platform for veterinary applications. Based on the positive data from the paper, Applied DNA intends to initiate an initial clinical trial for canine B-cell lymphoma in the current calendar year to validate the TERT cancer vaccine in conjunction with a lipid nanoparticle-based (LNP) delivery system.

Dr. Luigi Aurisicchio, CEO and chief scientific officer of Evvivax S.R.L., commented, “Prior clinical trials conducted by EvviVax using a plasmid DNA and adenovirus vector form of the TERT vaccine together with the standard of care chemotherapy showed an increase in the survival of canines with Stage III/IV B cell lymphoma by almost three-fold, from 37 weeks to 97 weeks. While clinically successful, our regulatory review was not extended due to hurdles related to the use of plasmid DNA, particularly as it relates to antibiotic resistance gene inclusion and manufacturing challenges in association with the adenovirus vector. We believe that the LinearDNA platform solves both issues.”

Dr. James A. Hayward, president and CEO of Applied DNA, stated, “The TERT vaccine is a de-risked approach to growing our veterinary portfolio to target lymphoma, the #1 cancer in dogs, for which we believe no vaccine is currently being marketed. Recently launched chemotherapies also offer the potential opportunity for a combination therapy approach to increase patient survival times. Our planned initial clinical trial is being designed to optimize the TERT vaccine and its delivery to gather data to support a larger clinical study, the outcome of which we believe will position the vaccine for a USDA APHIS conditional license application.”

The publication can be accessed on the Journal of Experimental & Clinical Research website: https://jeccr.biomedcentral.com/articles/10.1186/s13046-022-02402-5

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 cell-free 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 T therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies.

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.

Leveraging its deep expertise in nucleic acid-based technologies, the Company has also established safeCircle™, a high-turnkey solution for population-scale COVID-19 testing. safeCircle is designed to look for infection within defined populations or communities utilizing high throughput testing methodologies that increase testing efficiencies and provide for rapid turn-around-times.

The Company’s common stock is listed on NASDAQ under the ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under the ticker symbol ‘APPDW.’

Applied DNA is a member of the Russell Microcap® Index.

About Evvivax S.R.L.

Evvivax, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech  Evvivax pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on proprietary viral vectors and nucleic acid 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.