LineaRx Publishes Manuscript Demonstrating that a LinearDNA™ Vaccine Candidate was Protective in Virus Challenge Trial in Ferrets

Promising Results Support Further Development of LinearDNA as a Next Generation Vaccine Platform

STONY BROOK, N.Y. – September 26, 2022 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (‘Applied DNA’ or the “Company”), a leader in polymerase chain reaction (PCR”)-based technologies, today announced the publication of a manuscript, co-authored with international academic and industry scientists, containing data demonstrating that a LinearDNA™-based vaccine candidate (the “vaccine candidate”) reduced infectious virus shedding and was protective against SARS-CoV-2 in a challenge trial in ferrets. The purpose of the challenge trial was to demonstrate that LinearDNA-based vaccines can express therapeutic antigens that can confer protection against infection.

With the publication of these data, the Company’s vaccine candidate has now demonstrated induction of neutralizing antibodies and T cell responses against multiple SARS-CoV-2 variants and in multiple animal models, including mice, cats, and ferrets. The ferret model for respiratory disease closely mimics the pathogenesis of human COVID-19, and the receptor for the virus is similar in structure between humans and ferrets.

Supported by the Company’s recent demonstration that its LinearDNA constructs can be successfully administered in vivo using lipid nanoparticles (LNPs) and simple intramuscular injection, the Company believes that the breadth of data generated supports the further development of its LinearDNA™ platform to be a next-generation, host-expressed therapeutic DNA platform relevant to emergent (new pathogens) and non-emergent diseases (such as cancer).  

The manuscript, titled “A Linear SARS-CoV-2 DNA Vaccine Candidate Reduces Virus Shedding in Ferrets,” and associated study were sponsored by LineaRx, the Company’s majority-owned biotherapeutics subsidiary, and authored by LineaRx veterinary research collaborators at the Cornell University College of Veterinary Medicine, longtime LinearDNA development partner EvviVax, S.R.L., clinical trial administrator Veterinary Oncology Services, and members of the LineaRx research team. The manuscript is available in a preprint on bioRxiv and has been separately submitted for peer-reviewed publication.

As described in the manuscript, prime-boost vaccinations at different dose levels were administered to a cohort of 25 ferrets by intramuscular injection immediately followed by co-localized intramuscular electroporation to enhance the cellular uptake of the vaccine candidate for enhanced immunogenicity. No side effects or immune-enhanced disease were observed post-administration. After seroconversion, the study cohort was challenged with SARS-CoV-2 (5×10⁵ plaque-forming units intranasally). Post-challenge, viral shedding from the cohort was analyzed. The manuscript data show that the LinearDNA vaccine elicited both humoral and cellular immune responses with high titers of protective neutralizing antibodies, and, most importantly, it significantly reduced the shedding of infectious SARS-CoV-2 through oral and nasal secretions in the cohort.

Of note, the highest neutralizing titer and levels of reduced viral shedding were found in animals that received the lowest DNA dose. This suggests that a prime-boost regimen might be more critical to induce neutralizing antibodies than a highly concentrated dose of the vaccine. In addition, like the response elicited by live attenuated viruses, LinearDNA engaged the major histocompatibility pathways (MHC-I and MHC-II), including CD8+ and CD4+ T cells.

“These challenge data represent a major milestone in the commercialization of our LinearDNA platform. We have proven that a PCR-produced LinearDNA vaccine can be protective against live virus and reduce viral shedding, lessening the opportunities for the disease to spread,” stated Dr. James A. Hayward, president and CEO of Applied DNA and LineaRx. “Nearly one dozen vaccine platforms against COVID-19 have been approved by the World Health Organization (WHO). Continued global preparedness against the next pandemic will require choosing among the best platforms based on effectiveness, versatility, stability in distribution, ease of manufacture, expense, and rapidity of design against new pathogens. LinearDNA, we believe, meets these requirements while simultaneously solving many of the challenges associated with plasmid DNA. LinearDNA has broad applications, from research and development and drug discovery to precision medicines benefitting one patient at a time and for large-scale manufacturing for clinical and commercial use. We are one step closer to our LinearDNA platform serving as a common denominator for the next generation of genetic medicines.”

Stated Dr. Diego Diel, Associate Professor of Virology at the Cornell University College of Veterinary Medicine’s Department of Population Medicine and Diagnostics, “The results of the study demonstrate the efficacy of the platform for vaccine delivery in animals, which underscores the potential of the platform for infectious disease prevention in veterinary medicine.”  

Dr. Luigi Aurisicchio, CEO of Takis Biotech and EvviVax, added, “The data we have generated makes clear that a deep knowledge of the target disease biology and an appropriate molecular design, when coupled with the LinearDNA platform, can offer an immediate solution for infectious diseases as well as cancer. The veterinary market could immediately benefit from a LinearDNA approach to vaccine development while concurrently providing new knowledge for translation to human applications. We are strongly committed to making these next-generation vaccines available.”

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.