Codexis Announces Achievement of Gram-scale Synthesis with its ECO Synthesis™ Platform
December 13 2023 - 4:05PM
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.
About the ECO Synthesis™ Platform
Ribonucleic acid (RNA) as a therapeutic modality
has gained tremendous traction in recent years with the growing
number of messenger RNA (mRNA) vaccines and small interfering RNA
(siRNA) candidates advancing in clinical studies. However,
large-scale production of RNA interference (RNAi) therapeutics
using traditional chemical synthesis faces complex challenges in
nucleic acid quality and quantity, as well as overall economics.
With over 450 RNAi therapies currently in clinical development,
including more than 40 assets in Phase 2 and Phase 3 clinical
trials targeting disease indications impacting millions of
patients, RNAi therapeutic demand is projected to outpace current
production capabilities by the end of the decade. Codexis’
proprietary ECO Synthesis™ technology platform is being designed to
address these scalability and cost limitations by potentially
enabling the commercial-scale manufacture of RNAi therapeutics
through an enzymatic route. The Company achieved gram-scale
synthesis in December 2023, where it demonstrated the
preparative-scale manufacture of an oligonucleotide, composed of
the modified nucleotide building blocks typically used in RNAi
therapeutics, under process-like conditions. Codexis remains on
track to initiate early access customer testing in 2024.
About Codexis
Codexis is a leading enzyme engineering company
leveraging its proprietary CodeEvolver® technology platform to
discover, develop and enhance novel, high-performance enzymes and
other classes of proteins. Codexis enzymes solve for real-world
challenges associated with small molecule pharmaceuticals
manufacturing and nucleic acid synthesis. The Company is currently
developing its proprietary ECO Synthesis™ platform to enable the
scaled manufacture of RNAi therapeutics through an enzymatic route.
Codexis’ unique enzymes can drive improvements such as higher
yields, reduced energy usage and waste generation, improved
efficiency in manufacturing and greater sensitivity in genomic and
diagnostic applications. For more information, visit
https://www.codexis.com.
Forward-Looking Statements
This press release may contain 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, you can identify
forward-looking statements by terminology such as “aim,”
“anticipate,” “assume,” “believe,” “contemplate,” “continue,”
“could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,”
“may,” “objective,” “plan,” “positioned,” “potential,” “predict,”
“seek,” “should,” “suggest,” “target,” “on track,” “will,” “would”
and other similar expressions that are predictions of or indicate
future events and future trends, or the negative of these terms or
other comparable terminology. To the extent that statements
contained in this press release are not descriptions of historical
facts, they are forward-looking statements reflecting the current
beliefs and expectations of management, including but not limited
to statements regarding whether Codexis will be able to initiate,
and the timing of it initiating, pre-commercial customer testing of
its ECO Synthesis™ technology in 2024 and a full commercial
launch in 2026; the potential of the ECO Synthesis™ platform,
including its ability to be broadly utilized and to enable
commercial-scale manufacture of RNAi therapeutics through an
enzymatic route; the potential of an enzymatic route of synthesis
to drive improvements relative to traditional chemical synthesis
related to, among other things, nucleic acid quantity and quality
and overall economics; and expectations regarding future demand for
RNAi technologies. You should not place undue reliance on these
forward-looking statements because they involve known and unknown
risks, uncertainties and other factors that are, in some cases,
beyond Codexis’ control and that could materially affect actual
results. Factors that could materially affect actual results
include, among others: Codexis’ dependence on its licensees and
collaborators; if any of its collaborators terminate their
development programs under their respective license agreements with
Codexis; Codexis may need additional capital in the future in order
to expand its business; if Codexis is unable to successfully
develop new technology such as its ECO Synthesis™ platform and
dsRNA; Codexis' dependence on a limited number of products and
customers, and potential adverse effects to Codexis’ business if
its customers’ products are not received well in the markets; if
Codexis is unable to develop and commercialize new products for its
target markets; if competitors and potential competitors who have
greater resources and experience than Codexis develop products and
technologies that make Codexis’ products and technologies obsolete;
if Codexis is unable to accurately forecast financial and
operational performance; and market and economic conditions may
negatively impact Codexis' business, financial condition and share
price. Additional information about 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 27, 2023 and in Codexis’ Quarterly Report on Form 10-Q
filed with the SEC on November 3, 2023, including under the caption
“Risk Factors,” and in Codexis’ other periodic reports filed with
the SEC. Codexis expressly disclaims any intent or obligation to
update these forward-looking statements, except as required by
law.
For More Information
Codexis ContactsInvestor ContactCarrie
McKim(336) 608-9706ir@codexis.com
Media ContactLauren Musto(781)
572-1147media@codexis.com
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