Applied DNA Executes LOI with Spindle Biotech for Research Collaboration on Simplified High Yield mRNA Production System

0
231

STONY BROOK, N.Y. & TORONTO– Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in cell-free, enzymatic DNA production, and Spindle Biotech Inc. (“Spindle Biotech”), a company focused on the development of a novel, high yield, and low-cost RNA production systems, today announced that the two companies have executed a non-binding letter of intent (“LOI”) that outlines the terms of a collaborative research agreement (the “Definitive Agreement”) to investigate the feasibility of utilizing the Company’s LinearDNATM platform to produce chemically modified DNA templates for use in Spindle Biotech’s proprietary, high yield RNA manufacturing system. The companies believe the combination of their respective platforms provides for a simplified, high yield, and 100% cell-free workflow that is differentiated from current mRNA production that uses plasmid DNA (pDNA). In addition to increased speed and purity, the use of LinearDNA as an IVT template for mRNA production removes several complex manufacturing steps necessitated by pDNA.

The companies believe that Spindle Biotech’s proprietary, high yield, and engineered RNA polymerase, which requires a chemically modified DNA template, is particularly well suited to leverage the unique advantages of Applied DNA’s PCR-based LinearDNA platform. Under the proposed Definitive Agreement terms, Applied DNA will produce specialized IVT DNA templates for RNA transcription using Spindle Biotech’s RNA polymerase. Following initial validation work, the companies intend to explore the commercialization of an mRNA production system that leverages the benefits of the companies’ respective platforms.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, “We believe that Spindle’s mRNA manufacturing approach is a very good fit for our LinearDNA platform, which excels at the efficient production of chemically modified DNA constructs. As demand for mRNA therapeutics grows, Spindle Biotech and we are pursuing a simplified and efficient method to produce mRNAs with potential advantages in terms of cost, complexity, and production time versus standard pDNA methods to produce mRNA.”

Added Aaron Chung, CEO of Spindle Biotech, “Our preliminary studies suggest that a chemically modified LinearDNA-based IVT construct transcribed with our engineered RNA polymerase can offer at least five to ten-fold improvement in yield compared to conventional mRNA production methods using a wild-type T7 RNA polymerase. We believe that the increase in yield coupled with the speed and simplicity of the LinearDNA platform offers compelling advantages over legacy mRNA production methods. Combining Applied DNA’s LinearDNA production technology and Spindle’s proprietary RNA synthesis technology, the two companies can provide tremendous value to the mRNA community with a complete package of high-quality, scalable, and rapid mRNA manufacturing with minimal change to customers’ existing mRNA production pipeline.”

Completion of the Definitive Agreement is subject to the negotiation and successful execution of the Agreement by both companies. Accordingly, there can be no assurance that the Definitive Agreement will be entered into by the parties.