Applied DNA Biotherapeutics Subsidiary Reports LinearDNA™ Platform Development Milestone: First Successful Administration of LinearDNA In Vivo via Lipid Nanoparticles (LNP)

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) announced its subsidiary, LineaRx, successfully administered a linearDNA-LNP construct in mice via intramuscular injection without electroporation, enhancing the feasibility of LinearDNA-based therapies. This approach could potentially revolutionize applications in therapeutics, building on LineaRx's past successes, such as anti-lymphoma vaccines. The company is also formulating a canine lymphoma vaccine for similar administration. This achievement aligns with the rising significance of lipid nanoparticle (LNP) technology in vaccine delivery.

Positive

• Successful administration of linearDNA-LNP construct without electroporation enhances commercial viability.
• Potential for wide-ranging therapeutic applications based on prior successes in DNA constructs.
• Advancements in canine lymphoma vaccine formulation for intramuscular administration.

Negative

• Challenges remain in achieving FDA approvals for therapeutic use.
• History of net losses raises concerns about long-term financial viability.

– Use of LNP Simplifies Administration of LinearDNA-based Therapies, Potentially Enabling Their Application in Large Scale –

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in PCR-based DNA technologies, today announced that LineaRx, the Company’s majority-owned biotherapeutics subsidiary, has for the first time successfully administered and expressed a linearDNA-LNP construct in mice via routine intramuscular (IM) injection without the concurrent use of electroporation (EP) that utilizes electrical pulses to deliver DNA to target cells. The Company believes that the removal of the concurrent use of EP during administration potentially increases the commercial viability of LinearDNA-based therapies.

IM administered mRNA vaccines delivered via LNPs have altered the course of the COVID-19 pandemic. Using similar LNP technology, LineaRx has achieved expression in mice of a linearDNA-LNP construct encoding reporter proteins via simple IM injection. Unlike previous LinearDNA animal studies, concurrent EP was not utilized. The linearDNA-LNP construct used in the successful study was developed and manufactured by Applied DNA.

Based on LineaRx’s previous successes in the expression of various DNA constructs, including its therapeutic anti-lymphoma vaccine, CD123, and its epitope-optimized Spike gene from SARS-CoV-2, the Company believes that linearDNA-LNP constructs hold the potential to be used across a wide variety of therapeutic applications. Near term, LineaRx is working to formulate its canine lymphoma vaccine candidate for IM administration via LNP.

“Key members of our team have career histories working with lipidic delivery systems, including at very large scale, so LNPs are a natural extension of that work,” said Dr. James Hayward, president and CEO of Applied DNA Sciences and LineaRx. “We are pleased by the promise of today’s announcement, which supports our goal to develop LNP-based delivery of LinearDNA-based constructs for multiple therapeutic applications.”

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

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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220809005055/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 did Applied DNA Sciences announce regarding linearDNA-LNP on August 9, 2022?

Applied DNA Sciences announced that its subsidiary, LineaRx, successfully administered a linearDNA-LNP construct in mice using intramuscular injection without electroporation.

How does the new administration method for linearDNA-LNP improve its commercial viability?

The removal of electroporation simplifies the administration process, potentially increasing the appeal of LinearDNA-based therapies in the market.

What therapeutic applications are being explored with linearDNA-LNP technology?

The technology may have applications across various therapeutics, including vaccines for diseases like lymphoma and SARS-CoV-2.

What ongoing projects is LineaRx working on related to linearDNA-LNP?

LineaRx is formulating a canine lymphoma vaccine candidate for intramuscular administration using linearDNA-LNP technology.

What risks did Applied DNA Sciences highlight in its forward-looking statements?

The company noted risks such as achieving FDA approvals, market acceptance, and the uncertainties of clinical trials as potential challenges.