Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in cell-free, enzymatic DNA production, announced the formal launch of business development initiatives to expand the biotherapeutics industry’s awareness of the LinearDNA™ platform (the “platform”) as an alternative to current plasmid-based (pDNA) production processes used in the manufacture of DNA for advanced nucleic acid-based therapies. The initiatives, undertaken by LineaRx, Inc., a Company subsidiary focused on the commercialization of enzymatically produced DNA, position the platform as a source of high-fidelity DNA to help empower the rapid growth of advanced nucleic acid-based therapies. The initiatives include pre-print and peer-reviewed publications of upcoming preclinical data reads, presentations at industry conferences, business development activities related to partnering opportunities, and a revamp of the LineaRx website.
The Company believes that the platform addresses many of the issues associated with pDNA’s bacteria-based fermentation manufacturing process while outperforming pDNA in terms of speed, purity, flexibility, and scalability. The LinearDNA platform enzymatically produces a linear form of DNA (‘linDNA’), which the Company believes is relevant to a broad array of advanced therapeutic applications. In preclinical studies, linDNA has proven substitutable for pDNA in numerous nucleic acid-based therapies, including:
- Therapeutic and prophylactic DNA vaccines;
- DNA templates for in vitro transcription to produce RNA, including mRNA;
- Adoptive cell therapy manufacturing.
LineaRx is expanding linDNA’s use cases to include:
- Viral vector manufacturing for in vivo and ex vivo gene editing;
- CRISPR-mediated homology-directed repair;
- Non-viral gene therapy.
“We believe that the unprecedented demand for DNA, both for research and clinical development and for therapeutic manufacturing, is driving gene and cell therapy developers to seek out new forms of DNA production that can overcome the inclusion of antibiotic resistance genes that is becoming a topic of increasing regulatory scrutiny and solve the industry’s plasmid bottleneck,” stated Dr. James A. Hayward, president and CEO of Applied DNA and LineaRx. “LinearDNA is DNA made simple, giving therapy developers access to large quantities of high-fidelity DNA with the potential advantages of speed, purity, flexibility, and scalability over pDNA. The marketplace is ready for us, and we stand ready to deliver a new generation of DNA to support the next generation of advanced therapies.”
Formed in 2018 to commercialize its 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.
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.
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.'
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.