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

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) has announced the initiation of its first canine clinical trial for a lymphoma cancer vaccine, based on a peer-reviewed study published in The Journal of Experimental & Clinical Cancer Research. This study supports the use of the company’s LinearDNA™ platform, demonstrating promising preclinical data indicating a strong immune response in canine models. The vaccine targets B-cell lymphoma, the most common cancer in dogs, with plans for a trial to begin this year. This innovation could lead to a conditional license application with the USDA.

Positive

• Successful preclinical results showing strong immune response in canine models.
• Initiation of clinical trial for a novel cancer vaccine targeting B-cell lymphoma.
• Potential for a USDA conditional license application based on trial outcomes.

Negative

• Previous regulatory hurdles with plasmid DNA and adenovirus vector vaccines.
• Continued reliance on clinical trial data to validate the vaccine's efficacy.

- Data Supports Initiation of First Canine Clinical Trial by Applied DNA to Advance Canine Lymphoma Cancer Vaccine Licensed from EvviVax -    

STONY BROOK, N.Y. and ROME, Italy--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), 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.

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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 (www.takisbiotech.it). 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.

Forward-Looking Statements

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 (FDA), United State 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 FDA, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to FDA, USDA or equivalent foreign regulatory agencies, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, the unknown ability to manufacture the therapeutic grade DNA in large quantities, 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 9, 2021, its Quarterly Report on Form 10-Q filed on February 10, 2022 and May 12, 2022 and other reports it files 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220606005776/en/

Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com

Program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com

Web: www.adnas.com

Twitter: @APDN

Source: Applied DNA Sciences, Inc.

FAQ

What is the purpose of Applied DNA's canine clinical trial?

The trial aims to validate a lymphoma cancer vaccine using the LinearDNA™ platform in canines.

What type of cancer does the vaccine target?

The vaccine targets B-cell lymphoma, which is the most common cancer in dogs.

What were the results of the preclinical studies published?

The studies demonstrated a strong immune response and specific antitumoral effects in canine models.

When is the clinical trial for the canine lymphoma vaccine expected to begin?

The clinical trial is expected to begin within the current calendar year.

What is the significance of the LinearDNA™ platform in this trial?

The LinearDNA™ platform allows for large-scale, cell-free production of high-fidelity DNA sequences for the vaccine.