Codexis presents data on ECO Synthesis platform at TIDES USA meeting

Codexis (CDXS) presented data at the TIDES USA annual meeting in San Diego, California. Codexis’ presentations showcased its proprietary ECO Synthesis platform’s ability to support siRNA manufacturing by reducing purification costs, improving process performance, and demonstrating the potential to control stereochemistry. In addition, three presentations from contract development and manufacturing organizations including Bachem, Nitto Avecia, and ST Pharm validated the transferability of Codexis’ ligation processes to their in-house facilities. During an oral Main Stage presentation, Codexis used inclisiran as an example to showcase how the use of immobilized enzymes in its ECO Synthesis platform delivers a consistent process with improved performance. Using sequential enzymatic synthesis, we: Continued to achieve consistent coupling efficiency of greater than98%; Maintained the delivery of high product quality; Successfully decreased average cycle time by approximately 24%, translating into reduced production time; Demonstrated high yields of 30 grams of siRNA per liter. Using Codexis’ ligase to manufacture siRNA, our data demonstrated the potential to reduce or eliminate costly downstream purification steps. This benefit of ligation has led many companies to explore using this method in siRNA manufacturing. Codexis’ poster presentation highlighted how the Company’s recently launched machine learning tool is improving the success rate of ligation to produce siRNA. The tool aids process design by guiding the selection of optimal pairings of ligases and RNA fragments and has been shown to significantly outperform traditional fragment selection by four to sixfold. It also increases the probability of identifying fragment designs for which a single ligase can combine all fragments together in one reaction with greater than 90% efficiency. This approach has been validated through test molecules and partner case studies. By accelerating the ligase selection process and maximizing ligation efficiency, this tool demonstrates the potential to reduce process development time, lower costs, and enable an efficient manufacturing process for customers. In addition to Codexis’ presentations, Bachem, Nitto Avecia, and ST Pharm, three leading CDMOs in siRNA manufacturing, presented data on the use of Codexis ligases to successfully combine short RNA fragments. Each CDMO collaborator performed their ligations in-house, demonstrating that Codexis’ process can be easily transferred and the benefits across yield, purification, and impurity control can be replicated in customers’ hands. In a separate TIDES Talk presentation, Codexis highlighted a new feature under development for the ECO Synthesis technology to allow for stereochemical control during oligonucleotide synthesis. Stereochemistry refers to the presence of mirror-image forms, or chirality, of a therapeutic oligonucleotide strand, which can impact the efficacy and stability profile of siRNA therapeutics. Drug developers have little influence over stereochemistry today, as existing chemical manufacturing solutions produce mixtures of these mirror images that vary in terms of therapeutic potency. In contrast, the data in this oral presentation demonstrate how the ECO Synthesis platform can enable control over stereochemistry under process-relevant conditions. This differentiated capability would give customers the choice to define stereochemistry in their oligonucleotide products, potentially benefiting each assets’ therapeutic potency and market position.