Applied DNA Announces Publication of Peer-Reviewed Journal Article Validating Potential Use of linearDNA™ as a New Class of DNA-Based Vaccines

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) announced the publication of a peer-reviewed study in Molecular Therapy – Methods & Clinical Development, demonstrating the immunogenicity of its linearDNA vaccine candidate against SARS-CoV-2 in cats. This advancement supports the linearDNA™ platform for vaccine production. The company is also optimizing lipid nanoparticle (LNP) delivery systems to enhance vaccine administration. Concurrent studies with Cornell University aim to test LNP-encapsulated linearDNA in animal models, potentially paving the way for veterinary vaccines.

Positive

• Publication of peer-reviewed study supports linearDNA vaccine platform.
• Demonstrated immunogenicity of linearDNA vaccine candidate in cats.
• Advancement towards LNP-based delivery systems could enhance commercial viability.

Negative

• No current commercial approval for PCR-produced DNA therapeutics.
• Future clinical trials and FDA approvals remain uncertain.

- Company Advances Lipid Nanoparticle (LNP)-based Delivery System to Potentially Broaden LinearDNA Platform Commercial Utility -

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in PCR-based DNA technologies, today announced the publication of a peer-reviewed research article in Molecular Therapy – Methods & Clinical Development. The study, titled ‘A linear DNA vaccine candidate encoding the SARS-CoV-2 Receptor Binding Domain elicits protective immunity in domestic cats,’ supports the further development of the Company’s LinearDNA™ platform for the large-scale enzymatic (PCR, polymerase chain reaction) production of prophylactic and therapeutic linearDNA™-based vaccines. An initial manuscript detailing the study’s findings was published in preprint form on bioRxiv in July 2022.

The study demonstrated safety and immunogenicity of a linearDNA vaccine candidate against SARS-CoV-2 in a cohort of family-owned felines. Prime-boost vaccinations were administered by electro-gene-transfer intramuscularly to the cohort, which induced robust neutralizing antibody titers and cellular immune responses. The study was performed in conjunction with development partner EvviVax, S.R.L.

“This peer-reviewed publication supports the innovative work we and our partners are conducting to advance linearDNA as a potential new class of human and veterinary therapeutics that combines the rapid design and manufacturing capabilities akin to mRNA therapies with the thermostability and relative manufacturing simplicity of linearDNA. Adding to already robust data supporting the potential of linearDNA in-hand, this study and others being conducted and planned make a compelling case for linearDNA as a next-generation, DNA-based vaccine platform, in addition to its utility in the manufacture of other nucleic acid-based therapies, such as mRNA and CAR T therapies,” stated Dr. James A. Hayward, president and CEO of Applied DNA.

Concurrently, the Company is working to optimize the delivery in vivo of linearDNA to increase its ease of administration via LNPs that, if successful, would represent a significant turning point in increasing the commercial viability of linearDNA. The Company is currently progressing two LNP-related studies in parallel:

• One, the Company is working with Cornell University College of Veterinary Medicine to test whether a linearDNA vaccine encapsulated with an off-the-shelf LNP formulation can elicit a successful immune response when delivered via intramuscular injection to an animal model. If successful, it would mark the first time that LNP-encapsulated linearDNA would be shown to be immunogenic, thereby potentially opening the door for both prophylactic and therapeutic LNP-linearDNA veterinary vaccines;

• Two, the Company is working with a well-respected CDMO on an optimized LNP formulation for use with linearDNA. The goal of this study is to identify or develop a cost-effective LNP formulation that maximizes linearDNA’s immunogenicity in vivo. This study is currently underway, and early-stage in vitro screening studies have already been completed.

Concluded Dr. Hayward, “Our development work spanning linearDNA and LNP targets our first entry into the field of veterinary medicine, specifically the veterinary immuno-oncology market via a licensed DNA-based vaccine construct that has previously demonstrated compelling efficacy in canine models in plasmid form. We believe that linearDNA is well suited to address veterinary cancers, a leading disease-related killer of dogs, via a de-risked development path that minimizes therapy development costs and timelines while also generating additional data for its potential application to human health.”

To learn more about linearDNA™: click here

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, unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from any linearDNA-based therapeutic, whether any of Applied DNA’s or its customers 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), the U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval as therapeutic products from the FDA, the USDA, or equivalent foreign regulatory agencies, 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 its Annual Report on Form 10-K filed on December 14, 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/20230105005599/en/

Corporate Contacts:

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 significance of the recent study published by Applied DNA Sciences?

The recent study demonstrates the immunogenicity of a linearDNA vaccine candidate against SARS-CoV-2, supporting the development of the company's linearDNA™ platform.

How does Applied DNA plan to improve the delivery of its vaccines?

Applied DNA is optimizing lipid nanoparticle (LNP) delivery systems to enhance the administration of linearDNA vaccines, which may increase their commercial viability.

What future studies is Applied DNA conducting related to linearDNA vaccines?

The company is conducting studies with Cornell University to test LNP-encapsulated linearDNA vaccines in animal models.

What challenges does Applied DNA face with its linearDNA technology?

The company faces challenges including the absence of commercially approved PCR-produced DNA therapeutics and uncertainties regarding future FDA approvals.