Under the terms of the JDA, the Companies will seek to optimize mRNA quality, yields, and mitigation of contamination by double-stranded RNA ('dsRNA') in an integrated workflow at manufacturing scale and establish a global co-marketing relationship. Upon successful completion of the JDA, the Companies plan to negotiate agreements to enable the commercial launch of the joint workflow in the second half of calendar 2024.
The Linea IVT Platform combines Applied DNA's enzymatically produced Linea DNA IVT templates and its proprietary Linea RNA polymerase ('RNAP'), obtained through the recent acquisition of Spindle Biotech, to provide what Applied DNA believes to be numerous advantages over conventional mRNA manufacturing methods, including the prevention or reduction of dsRNA contamination and reduced mRNA manufacturing turn-around-times.
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About the Linea DNA and Linea IVT Platforms
The Linea DNA platform is a completely 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 saRNA 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 dsRNA contamination and 3) simplified mRNA production workflows.
About Kudo Biotechnology
Kudo Biotechnology is a leading global mRNA CDMO, providing world-class, end-to-end mRNA manufacturing solutions, all under one roof. Kudo has a state-of-the-art clinical GMP manufacturing facility and MSAT laboratories in
About
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, unknown future demand for its biotherapeutics or diagnostic products and services, the inherent risk and unknown outcome of research and development projects, the unknown amount of revenues and profits that will result from the Linea DNA and/or Linea IVT platforms, 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 human therapeutic use, our need to raise substantial additional funds, and various other factors detailed from time to time in Applied DNA's
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