Applied DNA Sciences (APDN) and EvviVax Announce Peer-Reviewed Publication of Positive Preclinical Data for the LinearDNA Platform as a Novel Cancer Vaccine Strategy in the Journal of Experimental & Clinical

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

The article, titled “Linear DNA Amplicons as a Novel Cancer Vaccine Strategy” and previously published on the preprint archive with open access and without reference bioRxiv in February 2022, studied two LinearDNA therapeutic cancer vaccines that were shown to produce a strong specific immune and antitumor response in mouse models using electrogen transfer (EGT) as a delivery method.

Applied DNA has granted an exclusive license to the anti-telomerase reverse transcriptase (TERT) cancer vaccine discussed in the article for its LinearDNA platform for veterinary applications. Based on the positive data from the paper, Applied DNA intends to initiate a first clinical trial for canine B-cell lymphoma in the current calendar year to validate the TERT cancer vaccine in conjunction with a lipid nanoparticle (LNP) delivery system.

Dr. Luigi Aurisicchio, CEO and Scientific Director of Evvivax SRL, commented: “Previous clinical trials conducted by EvviVax using a plasmid DNA and adenovirus vector form of the TERT vaccine with standard of care chemotherapy have shown a increase in dog survival. with stage III/IV B-cell lymphoma almost three times, from 37 weeks to 97 weeks. Although clinically successful, our regulatory review was not extended due to hurdles in the use of plasmid DNA, particularly with respect to the inclusion of antibiotic resistance genes and manufacturing challenges. in association with the adenovirus vector. We believe the LinearDNA platform solves both of these problems.

Dr. James A. Hayward, President and CEO of Applied DNA, said, “The TERT vaccine is a risk-free approach to expanding our veterinary portfolio to target lymphoma, the #1 cancer in dogs, for which we believe no vaccine is currently available. being marketed. Recently launched chemotherapies also offer the possibility of a combination therapy approach to increase patient survival times. Our planned initial clinical trial is 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