CDXS Codexis

Codexis Doses First Subjects in Phase 1a Trial of CDX-6114

Codexis Doses First Subjects in Phase 1a Trial of CDX-6114

Triggers $4 million milestone payment under strategic collaboration with Nestlé Health Science

REDWOOD CITY, Calif., July 09, 2018 (GLOBE NEWSWIRE) -- (NASDAQ:CDXS), a leading protein engineering company, announces that it has dosed the first subjects in a first-in-human Phase 1a dose-escalation trial with CDX-6114, its orally administered enzyme therapeutic being developed for the management of phenylketonuria (PKU).  The initiation of the trial triggers a $4 million milestone payment to Codexis from Nestlé Health Science under their strategic collaboration announced in October 2017. 

This randomized, double-blind, placebo-controlled Phase 1a trial is intended to evaluate the safety and tolerability of CDX-6114 in up to 32 healthy volunteers, with up to four cohorts receiving a single dose of CDX-6114 at increasingly higher dose levels. Codexis also expects to generate valuable pharmacology data from this study, which will support the future development of the drug candidate. The company expects to report topline results from the Phase 1a trial in the fourth quarter of 2018.

“Initiation of this clinical trial is a major milestone in the development of CDX-6114 for the management of the orphan metabolic disorder PKU. CDX-6114 is the first biotherapeutic discovered using our CodeEvolver® protein engineering platform to enter human studies,” said Codexis President and CEO John Nicols.  “Commencement of this clinical trial further validates our biotherapeutics strategy as PKU is the lead program in our pipeline, which focuses generally on the discovery and development of novel enzyme drug candidates for the treatment of rare diseases.”

“PKU is caused by the deficiency or absence of the natural enzyme for the metabolism of phenylalanine, and can lead to intellectual disability, seizures and cognitive and behavioral disabilities,” he added.  “Physicians have been able to test for PKU for more than 50 years, yet treatment options have been limited primarily to dietary management.  CDX-6114 is an orally dosed, GI-stable therapeutic enzyme developed to compensate for the missing natural enzyme.”

About Phenylketonuria (PKU)

PKU is an inborn metabolic disorder resulting from a mutation in the gene for the enzyme that converts the essential amino acid phenylalanine, present in almost all dietary protein, into tyrosine. As a result of this deficiency, phenylalanine builds up to levels that are toxic in the brain, causing serious neurological symptoms including intellectual disability, seizures and cognitive and behavioral disabilities. To avoid phenylalanine toxicity and the most severe disease symptoms, individuals with PKU must follow a strict, life-long diet that is low in phenylalanine and supplement their diet with a synthetic phenylalanine-free formula to provide sufficient nutrients. Maintaining a strict, life-long diet is a challenge for individuals with PKU. There are an estimated 50,000 people with PKU in the developed world.

About Codexis, Inc.

Codexis is a leading protein engineering company that applies its proprietary CodeEvolver® technology to develop proteins for a variety of applications, including as biocatalysts for the commercial manufacture of pharmaceuticals, fine chemicals and industrial enzymes, and enzymes as biotherapeutics and for use in molecular diagnostics. Codexis’ proven technology enables improvements in protein performance, meeting customer needs for rapid, cost-effective and sustainable manufacturing in multiple commercial-scale implementations of biocatalytic processes. For more information, see .

Forward-Looking Statements

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, including Codexis’ expectation of receiving a $4 million milestone payment from Nestlé Health Science as a result of commencing the Phase 1a study, Codexis’ expectation of completing the Phase 1a trial and reporting top line results in the fourth quarter of 2018, and Codexis’ belief that the commencement of this clinical trial further validates our biotherapeutics discovery and development strategy. 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; Codexis’ dependence on a limited number of products and customers in its biocatalysis business; potential adverse effects to Codexis’ business if its customers’ pharmaceutical or food products are not received well in the markets; risks, uncertainties and costs associated with the successful development of biotherapeutic candidates, including obtaining development partners for its biotherapeutic programs and progressing such programs to clinical trials and regulatory approvals; Codexis’ ability to develop and commercialize new products for the biocatalysis markets; Codexis’ dependence on a limited number of contract manufacturers for large-scale production of its enzymes; Codexis’ ability to deploy its technology platform in new market spaces, including the fine chemicals, therapeutics and in vitro molecular diagnostics markets; Codexis’ ability to comply with the terms of its credit facility and its associated debt service obligations; Codexis’ need for additional capital in the future in order to expand its business or to adjust for market conditions or strategic considerations, which may involve Codexis entering into equity offerings, debt financings, credit facilities and/or strategic collaborations; Codexis’ dependence on key personnel; Codexis’ ability to establish and maintain adequate protection for intellectual property, trade secrets and other proprietary rights covering its technologies; and any claims by third parties that Codexis is infringing their intellectual property rights or other proprietary rights. 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 March 16, 2018 and Form 10-Q filed May 10, 2018, including under the caption “Risk Factors” and in Codexis’ other current and periodic reports filed with the SEC. Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Codexis Contacts:

Investors

LHA Investor Relations

Jody Cain, (310) 691-7100

 

EN
09/07/2018

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Codexis

 PRESS RELEASE

Codexis Reports Fourth Quarter and Fiscal Year 2023 Financial Results

Codexis Reports Fourth Quarter and Fiscal Year 2023 Financial Results Anticipate 2024 Product Revenue Growth of at Least 10% vs. 2023 Excluding Enzyme Sales Related to PAXLOVID™ Recently Announced Debt Financing Reinforces Strong Financial Position with Projected Runway Through Expected Positive Cash-flow Around End of 2026 2024 to Focus on Securing Early Access Customers for ECO Synthesis™ Manufacturing Platform, Launch of Double-stranded RNA Ligase and Return to Growth for Pharmaceutical Manufacturing REDWOOD CITY, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS...

 PRESS RELEASE

Codexis Enters Exclusive Licensing Agreement for Newly Engineered Doub...

Codexis Enters Exclusive Licensing Agreement for Newly Engineered Double-Stranded DNA Ligase with Roche REDWOOD CITY, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced it has entered into an agreement with Roche for an exclusive, global license for the Company’s newly engineered double-stranded DNA (dsDNA) ligase for next-generation sequencing (NGS) library preparation and the Company’s EvoT4™ DNA ligase. Under the terms of the deal, Codexis will receive upfront and technical milestone payments. This deal supersed...

 PRESS RELEASE

Codexis to Participate in TD Cowen 44th Annual Health Care Conference

Codexis to Participate in TD Cowen 44th Annual Health Care Conference REDWOOD CITY, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced the Company will attend the TD Cowen 44th Annual Health Care Conference, being held March 4-6, 2024, in Boston, Massachusetts. Management will participate in a fireside chat on Monday, March 4, 2024, at 2:50 pm ET. A live webcast of the event will be available and in the Investor Relations section of the Company’s website, . A replay will be archived for 90 days following the even...

 PRESS RELEASE

Codexis Announces Appointment of Masad Damha, PhD, and Jim Lalonde, Ph...

Codexis Announces Appointment of Masad Damha, PhD, and Jim Lalonde, PhD, to Strategic Advisory Board Board expertise encompasses oligonucleotide research, development, manufacturing and commercialization to support development of ECO Synthesis™ manufacturing platform REDWOOD CITY, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced the appointment of Masad Damha, PhD, and Jim Lalonde, PhD, to the Company’s Strategic Advisory Board (SAB), joining John Maraganore, PhD, the founder and former Chief Executive Officer ...

 PRESS RELEASE

Codexis to Report Fourth Quarter and Fiscal Year 2023 Financial Result...

Codexis to Report Fourth Quarter and Fiscal Year 2023 Financial Results on February 28 REDWOOD CITY, Calif., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced that it will report its financial results for the fourth quarter and fiscal year 2023 on Wednesday, February 28, 2024, following the close of market. Codexis management will host a conference call and webcast at 4:30 pm Eastern Time to discuss the Company’s financial results and provide a business update. Participants may access the live webcast on the , where it...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch