Applied DNA Announces Notice of Allowance for U.S. Patent Covering Fundamental Aspect of its Linea(TM) IVT Platform
Applied DNA Sciences (NASDAQ: APDN) announced it received a Notice of Allowance from the USPTO for patent application 18/302,247, covering its Linea™ RNAP enzyme. This patent protects the composition of the enzyme, a core part of the company's Linea™ IVT platform, until 2041. The technology aims to streamline mRNA production, reducing contamination. Acquired from Spindle Bio in July 2023, Linea RNAP supports the manufacture of mRNA therapies, which are currently in high demand. Applied DNA is also set to start its GMP capabilities soon, reinforcing its commitment to providing critical materials for mRNA manufacturing.
- Notice of Allowance from USPTO for patent application 18/302,247.
- Patent protection for Linea™ RNAP enzyme extends to 2041.
- Linea™ RNAP aims to streamline mRNA production, reducing contamination.
- Upcoming initiation of GMP capabilities.
- Acquired Linea RNAP technology from Spindle Bio in July 2023.
- 450 mRNA therapies under development globally, with many in the preclinical stage.
- Potential to build significant market share in the mRNA production sector.
- Patent still pending in key international markets.
- High reliance on the success of mRNA therapies, which are still largely in preclinical stages.
The Notice of Allowance for the patent covering Applied DNA Sciences' Linea™ RNAP is quite significant. This enzyme is a key part of their Linea™ IVT platform, which is designed to improve mRNA production. mRNA technology is currently experiencing a boom, with around 450 mRNA therapies under development worldwide, many in the preclinical stage. The patent extends protection of this core technology until 2041, securing a long-term competitive edge for the company.
From a technical perspective, the Linea™ RNAP reduces double-stranded RNA (dsRNA) contamination, a significant issue in mRNA production. This can increase the overall quality and efficacy of mRNA therapies, potentially speeding up their development and approval processes.
For stakeholders, this news can be seen positively as it solidifies the technological foundation of Applied DNA, potentially leading to increased market share in the growing mRNA space. However, investors should be cautious about potential competition and the company's ability to commercialize this technology effectively.
From a financial standpoint, the patent protection until 2041 for the Linea™ RNAP is a valuable asset for Applied DNA Sciences. This ensures a prolonged period during which the company can capitalize on its proprietary technology without facing direct competition in this specific area. The mention of their commitment to supplying GMP-grade materials is promising, as it indicates a readiness to meet stringent regulatory standards, which could open doors to lucrative partnerships and contracts in the biotech and pharmaceutical industries.
However, investors should keep an eye on the company's financial health and their ability to scale production. While the patent establishes a solid technological moat, the true financial impact will depend on successful commercialization and adoption of the Linea™ IVT platform by mRNA therapy developers.
Patent covers the Composition of the Company's Proprietary Linea™ RNAP, a Core Technology Empowering the Linea™ IVT Platform
Patent Application Also Currently Pending in Key International Markets
STONY BROOK, NY / ACCESSWIRE / June 5, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, announced today that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 18/302,247, entitled "Compositions and Methods for RNA Synthesis."
The resulting patent will cover the composition of the Company's chemically modified RNA polymerase enzyme branded Linea™ RNAP, with expected patent protection into 2041. Linea RNAP is a core component of the Company's Linea™ IVT platform that empowers mRNA manufacturers to produce better mRNA faster via a simplified mRNA production workflow with reduced or eliminated double-stranded RNA (dsRNA) contamination. Applied DNA acquired the technology underlying the Linea RNAP via its acquisition of Spindle Bio, Inc. in July 2023.
"This patent allowance, coupled with the upcoming initiation of our GMP capabilities, demonstrates our commitment to supplying GMP-grade critical starting materials for the manufacture of mRNA," said Dr. James A. Hayward, president and CEO of Applied DNA. "With approximately 450 mRNA therapies under development globally, and with a large majority of these therapies in the preclinical stage, we believe we can build significant market share via our differentiated Linea IVT platform and its numerous advantages over conventional mRNA production workflows."
About the Linea™ DNA and Linea™ IVT Platforms
The Linea DNA platform is an entirely cell-free DNA production platform founded on Applied DNA's long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.
The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea™ RNAP to enable mRNA and sa-mRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of double-stranded DNA (dsRNA) contamination; and 3) simplified mRNA production workflows.
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.
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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, the availability of sufficient financial and other resources to meet business objectives and operational requirements the unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from its Linea IVT and or Linea DNA platforms, the development and utilization of, and challenges to, our intellectual property, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT platform 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, as amended, filed on December 7, 2023 and Quarterly Report on Form 10-Q filed on February 8, 2024, and May 10, 2024, 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.
Contacts:
Applied DNA Sciences
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Program contact: Clay Shorrock, 631-912-6454, clay.shorrock@adnas.com
Web: www.adnas.com
Twitter: @APDN
SOURCE: Applied DNA Sciences, Inc.
View the original press release on accesswire.com
FAQ
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