Enzymes are the engines that drive the fundamental chemical reactions that make life possible. They are responsible for metabolism, respiration, digesting food and movement, among many other bodily functions and chemical reactions. Essentially, enzymes are the building blocks of life. When enzymes are not working properly or are missing altogether, there can be detrimental impacts to the human body.
Codexis was initially built around its enzyme engineering capability based on its world-leading CodeEvolver® technology. CodeEvolver® enables the Company to tailor performance enzymes for specific applications and processes. That technology led to continual customer feedback that Codexis could solve difficult problems that couldn’t be overcome in their own labs or via chemical reactions. Today, the team is working to build out a suite of enzymes to enable an entire class of new medicines. This new, proprietary technology—Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis™—is built to support the development of ribonucleic acid interference (RNAi) therapeutics by efficiently synthesizing short inhibitory RNA (siRNA) oligonucleotide sequences.
Currently, there are five FDA-approved siRNA medications. However, there are more than 40 siRNA therapeutics in late-stage clinical trials and approximately 500 in clinical development examining both small- and large-scale indications, including cardiovascular disease, Alzheimer’s disease and cancer. siRNA-based drugs are positioned to be an important part of the future treatment paradigm with the potential to impact hundreds of millions of patients globally. However, the challenge with traditional methods is that the manufacturing process is not scalable and produces a significant amount of chemical waste. The issues with scalability of the current, chemical-based method of siRNA production will prohibit the necessary production to meet the incoming wave of demand.
Codexis’ ECO Synthesis™ technology is a proprietary new synthesis platform that is being developed for manufacturing siRNA therapeutics at scale. By replacing crucial chemical processes with enzymatic methods, ECO Synthesis™ technology is envisioned to address the scalability and significant utilization of hazardous waste in oligonucleotide manufacturing. In the next few years, the company intends to roll out its RNAi platform at industrial scale, which will enable the large-scale production of RNAi therapeutics in a way that couldn’t otherwise happen, potentially impacting hundreds of millions of patients globally.
The company plans to demonstrate gram-scale synthesis of its ECO Synthesis™ technology by the end of 2023, which will enable pre-commercial testing with select customers in 2024 before its planned commercial launch in 2026. The ECO Synthesis™ technology platform is where Codexis’ core technical competency and existing commercial infrastructure come together, positioning the company to potentially provide significant value in a market facing significant challenges to meet future anticipated demand as the industry aims to provide much-needed RNAi therapeutics.
