Agreement Seeks to Leverage Linea IVT Platform to Enable Kudo Bio to Offer a Differentiated mRNA Manufacturing Capability with Mitigated dsRNA and Reduced Turnaround Times
STONY BROOK, N.Y., and NEEDHAM, M.A. – December 14, 2023 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA), a leader in PCR-based DNA technologies, and Kudo Biotechnology (Kudo Bio), a leading global mRNA CDMO offering end-to-end cGMP mRNA manufacturing solutions, today announced their entry into a joint development agreement (the “JDA”) to integrate Applied DNA’s Linea™ IVT platform (the “Platform”) into Kudo Bio’s commercial mRNA manufacturing workflows.
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.
Dr. James A. Hayward, president and CEO of Applied DNA, stated, “The JDA is an important first step in the enablement of the commercial availability of a differentiated mRNA workflow empowered by our powerful platform. We believe that upon completion of the work under the JDA, Kudo Bio will possess critical advantages in turnaround time, scalability, and dsRNA reductions as compared to other mRNA CDMOs.”
Added Molly S. McGlaughlin, CEO of Kudo Bio, “We are excited to work with Applied DNA, a clear technology leader, to access cutting-edge technologies to significantly improve our customers’ cost of goods, speed to clinic, and overall safety to their patients!”
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 Shanghai, a Process Science Center of Excellence in Needham, MA, and with additional presence in Singapore. Offering a complete suite of services in pDNA, mRNA, LNP and Fill-Finish, our GMP manufacturing facility spans over 57,000 sqf and is designed in accordance with cGMP and global regulatory guidelines. Kudo’s facility features two plasmid lines, three mRNA lines, two LNP bulk lines, and one drug product fill & finish line. It can cater to manufacturing needs for preclinical through Phase 2 clinical trials, with capacity to manufacture up to 40 million vials/year for Phase 3 and commercial manufacturing. Our cutting-edge equipment is customized for mRNA and LNP drug development, and we offer a range of additional services, including Process and Analytical Development, Technology Transfer, Testing & Release, and Supply Chain Management. Kudo provides comprehensive solutions for our clients’ drug development needs, and has a robust quality management system to ensure the highest quality and to comply with global regulations. For more information, please visit www.kudobio.com, or follow us on LinkedIn @KudoBio
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 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 SEC reports and filings, including its Annual Report on Form 10-K filed on December 7, 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.
Applied DNA Sciences
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