On June 5, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, reported 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 (Press release, Applied DNA Sciences, JUN 5, 2024, https://adnas.com/apdn-us-patent-covering-fundamental-aspect-of-its-linea-ivt-platform/ [SID1234644115])."
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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.