Preclinical Orders for Additional Customers Underway
STONY BROOK, N.Y. November 9, 2023 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today announced that it has successfully manufactured and shipped its first research use only quantity of self-amplifying mRNA (saRNA) template generated by its Linea™ DNA platform (the “Platform”) to an unidentified preclinical therapeutic mRNA developer.
saRNA is a promising new form of mRNA therapy engineered to possess a self-replicating capability. Unlike conventional non-amplifying mRNA, saRNA carries the machinery necessary for its replication, resulting in a higher therapeutic index at a lower dose. Due to these advantages, interest in saRNA is rapidly growing, as evidenced by 10 active saRNA vaccine clinical trials as of Jan. 20231 and numerous companies engaged in preclinical studies to use saRNA to treat indications ranging from cancer to protein replacement therapies. Like mRNA, saRNA is also produced from a DNA template.
The manufacturing of saRNA, however, has proven to be challenging due to the large size and complexity of saRNA and its associated DNA IVT templates. The DNA templates for saRNA are often 3x-5x larger than the DNA templates for conventional non-amplifying mRNA. saRNA can also be challenging to produce efficiently in DNA plasmids, often leading to heterogeneous DNA sequences, low yields, and long manufacturing timelines.
In contrast, the Company’s Platform can rapidly and efficiently enzymatically produce the challenging DNA sequences necessary to produce saRNA with high levels of homogeneity, particularly in challenging sequences such as the poly(T) homopolymers required to produce saRNA. Due to these Platform advantages, the Company is working with additional customers to produce preclinical saRNA IVT templates.
“RNA technology is today central to the development of biologics for human health, and DNA is its manufacturing starting point,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “Development pipelines are beginning to see an uptake of saRNA for next-generation mRNA therapies. We believe our Platform’s ability to enzymatically produce the challenging and large DNA sequences needed to manufacture saRNA at scale puts us at the forefront of template manufacturing for this promising and growing mRNA modality.”
1 Schmidt C, Schnierle BS. Self-Amplifying RNA Vaccine Candidates: Alternative Platforms for mRNA Vaccine Development. Pathogens. 2023 Jan 13;12(1):138. doi: 10.3390/pathogens12010138. PMID: 36678486; PMCID: PMC9863218.
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 enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and, through our recent acquisition of Spindle Biotech, Inc. (“Spindle”), the development and sale of a proprietary RNA polymerase (“RNAP”) for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic 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, unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from the Linea DNA™ and/or Linea™ IVT platforms, limited market acceptance for its supply chain security products and services, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT or Linea DNA platforms 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, as amended, its 10-Q filed on February 9, 2023, May 11, 2023, and August 10, 2023, 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.