Applied DNA Biotherapeutics Subsidiary LineaRx and EvviVax Publish Additional Positive Animal Proof-of-Concept Data Supporting LinearDNA™ Platform as a Unique Approach to Veterinary DNA Vaccine Development

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) announced a manuscript publication demonstrating that its LinearDNA vaccine elicited neutralizing antibodies against SARS-CoV-2 in domestic cats. Developed by its subsidiary LineaRx in collaboration with EvviVax, the vaccine showed promising safety and immunogenicity. Additionally, the successful expression of the linDNA vaccine encapsulated in lipid nanoparticles (LNP) was confirmed, paving the way for future animal studies. The company is also exploring out-licensing opportunities for its canine lymphoma vaccine candidate, contingent on successful clinical trials and regulatory approvals.

Positive

• Demonstrated that LinearDNA vaccine successfully elicited neutralizing antibodies against SARS-CoV-2 in cats.
• Successful expression of linDNA vaccine encapsulated in lipid nanoparticles, set for further animal studies.
• Strong potential for out-licensing canine lymphoma vaccine candidate based on positive research data.

Negative

• Dependence on regulatory approvals and clinical trial success for further development.
• Limited financial resources which may hinder product development.

- Separately, LineaRx Announces Successful Expression In Vitro of Vaccine Candidate Encapsulated with Lipid Nanoparticles -

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in cell-free, enzymatic DNA production, today announced the publication of a manuscript containing data demonstrating that a linearDNA vaccine successfully elicited neutralizing antibodies and cellular immunity against SARS-CoV-2. The manuscript, authored by LineaRx, the Company’s majority-owned biotherapeutics subsidiary, and LineaRx’s development partner, EvviVax, S.R.L., further establishes the utility of the LinearDNA ("linDNA) platform as a large-scale enzymatic production approach to prophylactic and therapeutic veterinary vaccine applications.

The manuscript, "A Linear DNA Vaccine Candidate Encoding the SARS-CoV-2 Receptor Binding Domain Elicits Protective Immunity in Domestic Cats," is available in preprint on bioRxiv and will be submitted for peer-reviewed publication. It details positive data showing safety and immunogenicity of a linDNA vaccine candidate against SARS-CoV-2 in a cohort of family-owned cats. Prime-boost vaccinations were administered by electro-gene transfer intramuscularly to the cohort, which induced robust, protective neutralizing antibodies and cellular immune responses.

Separately, LineaRx announced the successful expression in vitro of its linDNA SARS-CoV-2 vaccine candidate encapsulated within lipid nanoparticles (LNP). The linDNA-LNP vaccine, designed and manufactured at the Company’s Stony Brook, New York facility, will be used in upcoming in vivo animal studies to assess the performance of linDNA-LNP vaccines and will inform the final design of the Company’s lead veterinary asset, a linDNA-LNP canine lymphoma vaccine candidate.

“Veterinary DNA vaccines are an exciting opportunity for us and this existing data further substantiates that linDNA is well-suited and efficacious for animal prophylactic and therapeutic vaccines. Further, when viewed alongside our positive LNP studies, we believe that a linDNA-LNP product has the strong potential to offer enhanced ease of administration and improved clinical outcomes,” stated Dr. Hayward, president and CEO of Applied DNA and LineaRx. “These data, together with other data generated by LineaRx over the past 24 months, have been invaluable in better understanding the performance of the linDNA platform for vaccine applications and have guided the design of our canine lymphoma vaccine candidate, for which we are currently identifying out-licensing animal health partners should our planned clinical trial meet all endpoints and gain USDA APHIS conditional approval.”

Added Dr. Luigi Aurisicchio, CEO of Evvivax S.R.L., “The results of this study confirm the potency of the genetic design and technology of our vaccines. SARS-CoV-2 is a zoonotic disease and finding a way to protect pets from infection may contribute to reduce viral reservoir and spreading. We believe that fully synthetic, linear DNA is a great platform providing gene therapy and enhanced vaccine products in short time for the prevention and the cure of many diseases.”

About LineaRx, Inc.

LineaRx, an Applied DNA Sciences, Inc. (NASDAQ: APDN) company, was formed in 2018 to commercialize the parent company's 20+ years of experience in polymerase chain reaction ('PCR')-based DNA manufacturing and leadership in enzymatic DNA production.

LineaRx is developing and commercializing the LinearDNA™ platform as a cell-free enzymatic platform for the large-scale DNA manufacture of high-fidelity DNA sequences for use in nucleic acid-based therapeutics.

DNA manufactured via the platform is free of adventitious DNA sequences and can be chemically modified to optimize DNA for specific applications, offering compelling advantages over plasmid DNA in many biotherapeutic applications, from mRNA and DNA vaccines to redirected cell and gene therapies.

To learn more about LinearDNA™: click here

About Applied DNA Sciences, Inc.

Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("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.'

About EvviVax

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 DNA 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 therapeutic grade DNA via PCR 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.

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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 were the results of Applied DNA Sciences' recent vaccine study?

Applied DNA Sciences reported that their LinearDNA vaccine successfully elicited neutralizing antibodies against SARS-CoV-2 in domestic cats.

What is the significance of the linDNA vaccine encapsulated in lipid nanoparticles?

The linDNA vaccine encapsulated in lipid nanoparticles showed successful expression and will be used in future animal studies to assess its effectiveness.

What are the next steps for Applied DNA Sciences concerning their canine lymphoma vaccine?

Applied DNA Sciences is identifying out-licensing partners for its canine lymphoma vaccine candidate, pending successful clinical trials and USDA approval.

Who collaborated with Applied DNA Sciences on the vaccine study?

The study was conducted in collaboration with EvviVax, S.R.L.

What challenges does Applied DNA Sciences face regarding its vaccine development?

The company faces challenges related to regulatory approvals and limited financial resources that could impact product development.