– Agreement Leverages Company’s Ability for Intramuscular Delivery of LNP-Encapsulated LinearDNA-based Therapies for Veterinary Therapeutic and Prophylactic Applications –
STONY BROOK, N.Y. and ITHICA, N.Y. – September 8, 2022 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (‘Applied DNA’ or the “Company”), a leader in polymerase chain reaction (“PCR”)-based technologies, and the Cornell University College of Veterinary Medicine (“CUCVM”) announced the signing of a research agreement (the “Agreement”) to advance LinearDNA™-based vaccine research and discovery for animal diseases with agricultural biosecurity implications. Primarily, the Agreement seeks to combine LinearDNA as a platform for rapid drug development with CUCVM’s expertise in viral vector design to advance a differentiated approach to animal vaccine development for infectious diseases.
The Agreement builds on the strong, existing collaboration between Applied DNA’s biotherapeutics subsidiary, LineaRx, and Dr. Diego Diel, D.V.M, M.S., PhD., Associate Professor of Virology at the Cornell University College of Veterinary Medicine’s Department of Population Medicine and Diagnostics. Dr. Diel is the lead investigator for veterinary clinical trials sponsored by the Company for the LinearDNA-based COVID-19 vaccine candidate and other therapeutic candidates in the Company’s pipeline.
Recently, Applied DNA announced the successful administration and expression of a lipid nanoparticle-encapsulated (LNP) LinearDNA construct in mice via routine intramuscular (IM) injection. Based on this positive data, the Company is currently advancing several LNP LinearDNA vaccine designs that will be utilized in upcoming preclinical animal studies. Data generated by these preclinical animal studies will advance the LinearDNA platform toward the commercialization of LNP-LinearDNA vaccines for both prophylactic and therapeutic applications and will inform the final design of the Company’s LNP-LinearDNA canine cancer vaccine candidate that is currently slated to begin an initial clinical trial during 1H calendar 2023.
“The Agreement is an opportunity to expand our work with Dr. Diel and his talented team to accelerate the application of the LinearDNA platform to the animal health market,” stated Dr. James A Hayward, president and CEO of Applied DNA and LineaRx. “Veterinary DNA vaccines present an attractive opportunity for us, and these animal studies should generate additional key validation data for our platform relevant to veterinary health. There is a continuing need for better veterinary therapies and we believe an LNP-LinearDNA product has the strong potential to offer enhanced ease of administration and improved clinical outcomes.”
Dr. Diel said, “Vaccinology research and clinical trials are crucial to developing new prevention strategies that could have transformative applications in animal health. This partnership will help to advance research and development of novel vaccine candidates for emerging infectious diseases in ways that can benefit us all, including human and animal patients.”
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid (“DNA”). Using PCR to enable both the production and detection of DNA, we operate in three primary business markets: (i) the manufacture of DNA for use in nucleic acid-based therapeutics; (ii) the detection of DNA in molecular diagnostics testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
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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.’
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 August 11, 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.
