REDWOOD CITY, Calif., May 14, 2024 (Globe Newswire) — Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced the development of enzyme route oligonucleotides to support RNA-based therapeutics. announced that they had succeeded in synthesizing nucleotides. Manufacturing industry. Data highlighting this historic manufacturing milestone will be presented today during a spotlight presentation at his TIDES USA Annual Meeting, to be held virtually May 14-17, 2024 in Boston, Massachusetts. .
“The data that Codexis presented today is truly unprecedented. We believe this is the first time that a full-length oligonucleotide has been enzymatically synthesized from a starting material via ligation of the linking moiety.” , provides industry with meaningful evidence of the process that as demand for RNAi therapeutics increases, there are alternative manufacturing methods available. “The ECO Synthesis™ manufacturing platform has the potential to be a scalable and sustainable way to manufacture this important and growing new class of medicines,” he said, founder and former CEO of Alnylam Pharmaceuticals. said Dr. John Maraganore, Strategic Advisory Member, Codexis. board.
Codexis enzymatically synthesizes fully modified RNA oligonucleotides
During the presentation, Codexis will present data on the enzymatic synthesis of known siRNA oligonucleotides that incorporate the nucleotide modifications most frequently found in currently approved therapeutic assets. This includes the synthesis of siRNA compounds using the company’s enzyme-catalyzed oligonucleotide (ECO) Synthesis™ manufacturing platform, from starter oligonucleotides to incorporation of binding moieties. This final step prepares the oligonucleotide for attachment of the customer’s unique targeting moiety, allowing the therapeutic to be delivered directly to the desired cells. According to key data from the presentation, the ECO Synthesis™ manufacturing platform is:
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Incorporate RNA bases containing common modifications used in current siRNA therapeutic assets
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Achieves coupling efficiency of over 98%
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We performed enzymatic addition of the conjugate moiety
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Confirms the absence of significant impurities typically observed in phosphoramidite chemical synthesis
Having achieved this important technological milestone, Codexis has optimized yield, purity, and quality with the goal of providing customers with siRNA material that is as good or better than phosphoramidite chemistry for preclinical testing. Process development continues.
Codexis launches RNA ligase screening and optimization services
Codexis also today announced the launch of RNA ligase screening and optimization services. An overview of this new service will be featured in his TIDES talk session on Thursday, May 16, 2024.
During phosphoramidite chemical synthesis of RNA, each nucleotide added to the growing oligonucleotide amplifies unique coupling errors, leading to a decreased yield of the desired full-length RNA construct. By utilizing a ligation approach, multiple short single-stranded RNA (ssRNA) fragments are synthesized via phosphoramidite chemistry or the ECO Synthesis™ manufacturing platform, double-stranded, and ligated with ecoRNA™ double-stranded ligase to achieve the desired can form double strands. -Stranded RNA (dsRNA) constructs. This method has the potential to provide higher purity and yield, allowing for increased scalability and reduced manufacturing costs.
As part of Codexis’ Enzymatic RNA Synthesis Center of Excellence, the company provides RNA ligase screening and optimization services. This includes custom evolution of dsRNA ligase enzyme variants, screening and protocol optimization for dsRNA ligase production and use, and research. Grade RNA production for future preclinical studies. For more information about Codexis’ new RNA ligase screening and optimization services, please visit the Products and Services section of our corporate website.
“This week’s presentations clearly demonstrate our ability to enzymatically generate full-length oligonucleotides.” We are excited about the rapid advances in the evolution of , incorporation of modified nucleotides, and attachment of binding moieties, which we will complement with the launch of our RNA ligase screening and optimization program, which will ultimately combine with ligation. We now offer sequential enzymatic synthesis to deliver full-length siRNA constructs,” said Stephen Dilly, MBBS, Chief Executive Officer of Codexis. . “We have heard great excitement about these developments from potential customers, partners, and collaborators, and our team has already scheduled dozens of meetings this week to build on the ECO Synthesis™ platform and RNA We plan to have further discussions with prospective CDMO and drug developer customers about both of our ligase programs.”
Presentation details
title: Enzymatic oligonucleotide synthesis process flow and material impurity profile
date: Tuesday, May 14, 2024
time: 12:45pm – 1:15pm ET
position: Spotlight presentation, luncheon 1
Presenter: Derek Gauntlett, MBA, Codexis Director of Bioprocess Chemistry
title: Two enzymatic approaches for large-scale siRNA synthesis
date: Thursday, May 16, 2024
time: 10:10am – 10:20am (Eastern Standard Time)
position: TIDES talk, exhibition hall
Presenter: Dr. Matthew Miller, Director of Life Sciences and RNA Technology, Codexis
Slide decks for both presentations are now available on Codexis’ corporate website (www.codexis.com). A recording of the presentation will be made available after the conference.
Attendees of the TIDES USA conference can visit Codexis at booth #628 in the exhibit hall to learn more about the ECO Synthesis™ manufacturing platform and the company’s RNA ligase screening and optimization services.
About the ECO Synthesis™ manufacturing platform
Ribonucleic acid (RNA) as a therapeutic modality has attracted significant attention in recent years, with an increasing number of messenger RNA (mRNA) vaccines and small interfering RNA (siRNA) candidates undergoing clinical investigation. However, large-scale production of RNA interference (RNAi) therapeutics using conventional chemical synthesis faces complex challenges in terms of nucleic acid quality and quantity, as well as overall economics. More than 450 RNAi therapeutics currently in clinical development, including more than 40 assets in phase 2 and 3 clinical trials for disease indications affecting millions of patients. , demand for RNAi therapeutics is predicted to outstrip current production capacity by the end of this decade. Codexis’ proprietary ECO Synthesis™ manufacturing platform is designed to address these scalability and cost limitations by enabling commercial-scale manufacturing of RNAi therapeutics via the enzymatic route. The company achieved gram-scale synthesis in December 2023, demonstrating the production of oligonucleotides composed of modified nucleotide building blocks commonly used in RNAi therapeutics at a preparative scale under conditions similar to the process. did.
About Codesis
Codexis is a leading enzyme engineering company powered by its proprietary CodeEvolver.® A technology platform for discovering, developing, and enhancing novel high-performance enzymes and other classes of proteins. Codexis enzymes solve real-world challenges related to small molecule drug manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis™ manufacturing platform, which will enable large-scale manufacturing of RNAi therapeutics via the enzymatic route. Codexis’ proprietary enzymes can drive improvements such as higher yields, reduced energy use and waste generation, increased manufacturing efficiency, and increased sensitivity for genomic and diagnostic applications. For more information, please visit https://www.codexis.com.
Forward-looking statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, the words “aim,” “anticipate,” “anticipate,” “believe,” “consider,” “continue,” “may,” “design,” and “plan.” You can identify forward-looking statements by terms such as: “estimate”, “expect”, “goal”, “intend”, “may”, “objective”, “plan”, “position”, “could”, “predict”, “seeks,” “should,” “suggests,” “aims,” ”will,” “intends,” “will” and predicts or indicates future events or future trends. Any other similar expressions or the negation of these terms or other equivalent terms. Statements contained in this press release, to the extent that they are not statements of historical fact, reflect management’s current beliefs and expectations, including, but not limited to, the complementary or effective capabilities of the enzymatic oligonucleotide synthesis process. These are forward-looking statements. Replaces traditional chemical synthesis. The potential for our ECO Synthesis™ platform and RNA ligase screening and optimization services to create value for Codexis and its customers by enabling the delivery of full-length siRNA constructs. other anticipated technical and commercial milestones and related public announcements related to the ECO Synthesis™ platform and dsRNA ligase program; Potential details and features of the ECO Synthesis™ platform. It is scalable, reduces manufacturing costs, and has higher purity and yield than existing methods. and future demand for RNAi therapeutics. These forward-looking statements involve known and unknown risks, uncertainties and other factors that, in some cases, are beyond Codexis’ control and may materially affect actual results. Don’t rely on it too much. Factors that could materially affect actual results include, among others: Reliance on Codexis Licensees and Collaborators. Codexis’ ability to successfully develop new technologies such as the ECO Synthesis™ platform and dsRNA ligase programs; If any of the collaborators terminates the development program under their respective license agreements with Codexis. Codexis may require additional capital in the future to expand its operations. Codexis is dependent on a limited number of products and customers, and if its customers’ products are not accepted in the marketplace, Codexis’ business could be adversely affected. the ability of end markets for Codexis’ customer products to develop and survive; competitors and potential competitors with greater resources and experience than Codexis develop products and technology that render Codexis’ products and technology obsolete; ability to comply with debt covenants under Codexis financing facilities; Market and economic conditions may adversely affect Codexis’ business, financial condition and stock price. Additional information regarding factors that could materially affect actual results can be found in Codexis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 28, 2024 and Codexis Form 10-K Quarterly Report. Q filed with the SEC on May 2, 2024, under the caption “Risk Factors” and in Codexis’ other periodic reports filed with the SEC. Codexis expressly disclaims any intention or obligation to update these forward-looking statements, except as required by law.
For more information
Investor contact information
Carrie McKim
(336) 608-9706
ir@codexis.com
media contact
Lauren Musto
(781) 572-1147
media@codexis.com
