Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company,
today highlights several key presentations from its gene therapy
programs from 19th Annual WORLDSymposium™, taking place from
February 22-26, 2023, in Orlando, Florida.
Notably, preclinical data in Fabry disease using its engineered
transgene is being presented by its partner Takeda Pharmaceutical
Company Limited (Takeda). This program is part of Codexis’
Strategic Collaboration and License Agreement with Takeda, under
which Codexis leverages its CodeEvolver® protein engineering
platform to generate novel gene sequences encoding enzyme variants
that are tailored to enhance efficacy by increasing activity,
stability, and cellular uptake. Takeda is combining these improved
transgenes with its gene therapy capabilities to develop novel
product candidates for the treatment of rare genetic disorders. As
part of the partnership, Codexis has engineered a unique
α-galactosidase A (a-GLA) protein variant that may enable Takeda to
address the limitations of existing standards of care in Fabry
disease.
“Our strategic collaboration with Takeda allows us to
demonstrate our platform’s leading enzyme engineering capabilities
in the context of gene therapy,” said Stephen Dilly, MBBS, Ph.D.,
President and Chief Executive Officer of Codexis. “Using our
CodeEvolver® platform to iterate upon naturally occurring enzymes,
we are engineering an a-GLA protein variant with enhanced stability
and reduced immunogenicity to potentially overcome the challenges
historically associated with gene therapy approaches for Fabry
disease. Our ability to tailor enzymes with specific, desirable
characteristics and improved expression profiles pairs nicely with
Takeda’s gene therapy expertise as we continue working to address
the high unmet need in rare genetic disorders.”
Fabry disease is a rare lysosomal storage disorder in which the
body cannot efficiently break down lipids into smaller components.
The disease stems from a deficiency in a-GLA. Low levels of a-GLA
activity result in the accumulation of globotriaosylceramide (Gb3)
in the lysosomes of various tissues, which can eventually
negatively impact organs, including the heart, kidney, peripheral
nervous system, skin, and gastrointestinal (GI) tract. Patients
suffer from symptoms such as pain, fatigue, and renal and cardiac
disease. While enzyme replacement therapy (ERT) is available for
Fabry disease, treatment efficacy is routinely compromised by the
short in vivo half-life and the development of anti-drug
antibodies.
Takeda’s poster presentation, titled, “Preventing Fabry disease
progression in a symptomatic mouse model with a recombinant
adeno-associated virus (rAAV) based gene therapy,” highlights its
rAAV-based gene therapy candidate for the potential treatment of
Fabry disease. The gene therapy candidate is being developed to
encode the codon optimized, CodeEvolver® engineered a-GLA enzyme,
which is designed to have improved serum and lysosomal stability
and a predicted reduced immunogenicity.
Codexis is also presenting two abstracts highlighting its gene
therapy program in GM1 Gangliosidosis (GM1) at WORLDSymposium™.
Similar to the Fabry disease program, these data demonstrate the
promise of Codexis’ CodeEvolver® platform to engineer an optimized
enzyme for administration as a transgene in gene therapy to
potentially slow and/or reverse GM1 disease progression. The
posters, “An engineered β-galactosidase with improved stability and
cross-correction for the potential treatment of GM1 Gangliosidosis
via AAV gene therapy” and “In vitro modeling of GM1 Gangliosidosis
using iPSC-derived cellular and organoid CNS models” will be
available on the WORLDSymposium™ OnDemand platform and are also
available on the Company’s website
at www.codexis.com/resources.
About Codexis
Codexis is a leading enzyme engineering company leveraging its
proprietary CodeEvolver® platform to discover and develop
novel, high performance enzymes and biotherapeutics. Codexis
enzymes have applications in the sustainable manufacturing of small
molecule pharmaceuticals, in RNA and DNA synthesis and the creation
of next generation life science tools, and as gene therapies and
oral enzyme therapies. Codexis’ unique enzymes can drive
improvements such as higher yields, reduced energy usage and waste
generation, improved return on capital in manufacturing, improved
sensitivity in genomic and diagnostic applications, and more
efficacious therapeutics. For more information,
visit 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. To the extent that statements contained in this press
release are not descriptions of historical facts regarding Codexis,
they are forward-looking statements reflecting the current beliefs
and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
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. All statements other than statements of historical
facts contained in this press release are forward-looking
statements. Such forward-looking statements include, but are not
limited to, statements regarding the efficacy of Takeda’s product
candidate and whether such product candidate will be able to
address the limitations of existing standards of care; and the
promise of Codexis’ CodeEvolver® platform to engineer an optimized
enzyme for administration as a transgene in gene therapy. 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, including, but not
limited to, the development of Takeda’s product candidate for the
treatment of Fabry disease being subject to a collaboration
agreement that could be terminated; Codexis and or its partners
being unable to obtain regulatory approval for their product
candidates given the lengthy, time consuming and inherently
unpredictable nature of such approval processes; clinical trials
being difficult to design and implement, expensive, time-consuming
and thus involving an uncertain outcome; results of preclinical
studies and early clinical trials of product candidates may not be
predictive of results of later studies or trials; and market and
economic conditions negatively impacting Codexis or its partners’
business and financial condition. Additional information about
factors that could materially affect actual results can be found in
Codexis’ Annual Report on Form 10-K to be filed with the Securities
and Exchange Commission (SEC) on or about February 24, 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.
Investor Relations Contact:
Argot PartnersBrendan Strong/Carrie McKim(212)
600-1902Codexis@argotpartners.com
Media Relations Contact:
Lauren Mustolauren.musto@codexis.com
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