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Milestone enables Codexis engineers to model the manufacturing process for RNAi therapeutics
Company remains on track to initiate pre-commercial customer testing in 2024
REDWOOD CITY, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ:CDXS), a leading enzyme engineering company, today announced it has achieved gram-scale synthesis with its Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis™ technology. This critical technical milestone demonstrates the preparative-scale manufacture of an oligonucleotide, composed of the modified nucleotide building blocks typically used in ribonucleic acid (RNA) therapeutics, under process-like conditions.
Successful completion of this milestone enables Codexis engineers to initiate a comprehensive assessment of the purity profile for small interference RNA (siRNA) developed with ECO Synthesis™ technology. Separately, data collected on process-related parameters provides foundational information for early models of the siRNA manufacturing process and allows the Company to open conversations with early access customers on their RNA interference (RNAi) therapeutics manufacturing processes. Early access customer testing is on track to initiate in 2024 ahead of an anticipated full commercial launch in 2026.
"Our scientists have done outstanding work to bring us to this critical milestone for the development of our ECO Synthesis™ technology so rapidly. We have increased production scale by four orders of magnitude since August to move into preparative scale of the oligonucleotide. This is significant because it allows our engineers to begin modeling and testing manufacturing methods with confidence, which will enable us to start sharing data-driven insights with potential customers on key metrics like purity profile," said Stephen Dilly, MBBS, PhD, Chief Executive Officer of Codexis. "Furthermore, we have demonstrated the ability of our enzymes to include modified building blocks reliably and with high conversion efficiency in a timely fashion. This, together with our steady progress in the enzymatic synthesis of the nucleotide building blocks and starter oligonucleotide, gives us real excitement for the potential of the ECO Synthesis™ platform and we look forward to initiating pre-commercial testing next year."
The need for an enzymatic route of synthesis for RNAi therapeutics was recently reinforced at the Company's virtual KOL investor event featuring John Maraganore, PhD, Founder and Former Chief Executive Officer of Alnylam Pharmaceuticals and Codexis Strategic Advisory Board member, and David Butler, PhD, Chief Technology Officer of Hongene Biotech Company. These distinguished experts were joined by Codexis leadership and discussed the growth of RNAi therapeutics as a modality, the manufacturing landscape and the potential role for Codexis' ECO Synthesis™ platform to enable commercial-scale production of RNAi therapeutics. A replay of the virtual event is accessible on the Investor Relations section of the Company's website, https://ir.codexis.com.
Posted In: CDXS
