IARPA, Ginkgo Bioworks and Draper Announce New Technologies to Detect Engineered DNA – Investing News Network

– The Intelligence Advanced Research Projects Activity (IARPA), the research and development arm of the U.S. Intelligence community, Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming and Draper, a nonprofit engineering innovation firm, today announced the completion of IARPA's Finding Engineering-Linked Indicators ( FELIX) program . The program was created to augment and improve current biodetection and biosurveillance capabilities. Specifically, Ginkgo has developed a suite of new computational tools and Draper has developed a new experimental platform to help detect and identify when samples include genetically engineered biological systems. The results from the program will be presented on October 17, 2022 at 11am Eastern on YouTube.

Current methods for detecting signs of biological engineering are typically costly, slow, and capable of detecting only a subset of all possible genetic modifications. In collaboration with IARPA, Ginkgo developed an initial set of computational tools called ENDAR (Engineered Nucleotide Detection and Ranking) that assist trained analysts to identify genetic engineering in next generation sequencing (NGS) datasets. This software aims to make it possible for scientists to detect engineered DNA at scale.
"Through their work on the FELIX program, Ginkgo and Draper have achieved two major breakthroughs for the biodetection community," said David A. Markowitz , Program Manager at IARPA. "The ability to detect genetic engineering in complex biological samples has long been a moonshot goal, and these new capabilities are poised to transform national biosecurity efforts."
Designed to work across a range of biological organisms that may be found in complex, multi-species environments, ENDAR tools and methods could provide early alerts to the presence of engineered organisms and help expedite appropriate responses, thereby mitigating adverse consequences.
"Ginkgo has a core belief in the promise of engineered biology—a thriving bio-based economy that delivers benefits to society, the environment, and our health. We care deeply about securing that vision by ensuring that biology is engineered and deployed responsibly," said Jason Kelly , CEO and co-founder, Ginkgo Bioworks. "Working with IARPA, we've developed a fundamentally new biosecurity capability that will enhance our ability to detect, characterize, and respond to biological threats. We're excited to explore opportunities to deploy ENDAR as an integral component of our global biosecurity platform."
Draper's contributions to FELIX, under its contract with IARPA, include development of a lab-based genetic test, a custom bioinformatics pipeline that contextualizes DNA sequencing data and miniaturized microarray hardware all with the goal of characterizing otherwise impossible to detect genetic engineering. Potential applications include biothreat detection, environmental monitoring, and food inspection.
"At Draper, we believe that advances in gene editing technology are creating new opportunities for biosecurity," said Laura Seaman , Principal Scientist and Machine Intelligence group leader at Draper. "Under the FELIX program, we have developed a device and associated lab and computational methods that are sensitive enough to pick out an engineered organism in a complex environmental background containing millions of natural organisms—the signal-to-noise ratio is a significant improvement over current methods."
The event will feature a panel with participants including, Catherine Marsh , IARPA Director; David A. Markowitz , IARPA Program Manager; Joshua Dunn , Head of Design, Ginkgo Bioworks; Laura Seaman , Principal Scientist and Machine Intelligence Group Leader, at Draper; and Erin Rosenberger , Senior Member of Technical Staff, Biological Microsystems Group, at Draper. During the panel, the panelists will discuss the program findings and also feature a demo of the research results.
The presentation of results from the FELIX program on October 17 will be livestreamed. To register, please visit this link , which can also be accessed Monday at 11am Eastern via the Ginkgo Bioworks channel on YouTube.
The Intelligence Advanced Research Projects Activity (IARPA) invests in high-risk, high-payoff research programs to tackle some of the most difficult challenges of the agencies and disciplines in the Intelligence Community. IARPA's mission is to push the boundaries of science to develop solutions that empower the Intelligence Community to do its work better and more efficiently for national security.
At Draper, we believe exciting things happen when new capabilities are imagined and created. Whether formulating a concept and developing each component to achieve a field-ready prototype or combining existing technologies in new ways, Draper engineers apply multidisciplinary approaches that deliver new capabilities to customers. As a nonprofit engineering innovation company, Draper focuses on the design, development and deployment of advanced technological solutions for the world's most challenging and important problems. We provide engineering solutions directly to government, industry and academia; work on teams as prime contractor or subcontractor; and participate as a collaborator in consortia. We provide unbiased assessments of technology or systems designed or recommended by other organizations—custom designed, as well as commercial-off-the-shelf. For more information, visit www.draper.com .
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential success of the partnership and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
IARPA MEDIA CONTACT:
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Ginkgo to engineer key biocatalytic enzymes for potential use in Merck's drug manufacturing processes
Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced a collaboration with Merck, known as MSD outside the United States and Canada to engineer up to four enzymes for use as biocatalysts in Merck's active pharmaceutical ingredient (API) manufacturing efforts. Through this collaboration, Ginkgo will leverage its extensive experience in cell engineering and enzyme design, as well as its capabilities in automated high throughput screening, manufacturing process developmentoptimization, bioinformatics and analytics to deliver optimal strains for expression of targeted biocatalysts.
Biocatalysis is a sustainable and often more effective alternative to some chemical synthesis steps in industrial chemical synthesis. The inherent stereospecificity of enzyme biocatalysts can reduce costly synthesis and purification steps, thereby decreasing production costs. Through this collaboration, Ginkgo aims to optimize several biocatalysts by leveraging its world-class proprietary fungal strains, cell line development, enzyme engineering and optimization, and multiomics expertise.

"Ginkgo's fungal strains present a major opportunity for improving biocatalysis. E. coli is currently the mainstay host for expressing enzymes, but a large number of enzymes will not express properly in E. coli , and those that do express in E. coli may have better homologs that only express in fungal strains," said Behzad Mahdavi , Senior Vice President of Biopharma Manufacturing and Life Sciences Tools at Ginkgo. "This enzyme optimization project with Merck has the potential to help reduce the cost of goods and enable a more robust supply chain for APIs."
"Merck is a pioneer in biocatalysis, improving manufacturing of crucial medicines. We're thrilled to be partnering with Merck, and to be leveraging our platform capabilities for improved enzyme activity and production" said Jason Kelly , co-founder and CEO at Ginkgo. "Ginkgo's platform model enables us to identify improved enzymes and develop powerful fungal strains and fermentation processes for enzyme manufacturing, empowering downstream API production for our customers."
Under the terms of the collaboration, Ginkgo will earn an upfront research and development fee and is eligible for success-based research and development milestone payments. In addition, Ginkgo is eligible to earn commercial milestone payments for each of a specified number of biocatalysis targets, which have the potential to total, in the aggregate, up to $144 million . To learn more about Ginkgo's work in enzyme discovery, visit ginkgobioworks.com/our work/enzyme-discovery .
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential success of the collaboration and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
GINKGO BIOWORKS INVESTOR CONTACT:
investors@ginkgobioworks.com
GINKGO BIOWORKS MEDIA CONTACT:
press@ginkgobioworks.com
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Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the tuck-in acquisition of Circularis, a biotechnology company with a proprietary circular RNA and promoter screening platform. When circularized, RNA is much longer-lived in cells, improving its robustness as a potential therapeutic modality. The Circularis platform also allows ultra-high-throughput screening of promoters and other enhancers. Ginkgo is excited to welcome the Circularis team and platform to enable new solutions across bioproduction, RNA therapeutics, cell therapy, and gene therapy partnerships.

In recent years, Ginkgo has significantly expanded its work in cell and gene therapy, including a program to improve adeno-associated virus (AAV) manufacturing in partnership with Biogen , and a program to develop AAV capsids with altered tropism and immunogenicity in partnership with Selecta Biosciences . The field of nucleic acid therapeutics is a promising novel therapeutic modality, and Ginkgo has worked on programs across the space, including with Moderna and Aldevron , and is actively engaged in improving circular RNA efficacy and manufacturing yields.

The Circularis platform strengthens Ginkgo's platform for development of cell and gene therapies, providing the capability to rapidly identify novel promoters with appropriate strength and tissue-specificity designed into customer specific delivery modalities. Leveraging Ginkgo's ability to explore large numbers of genetic designs, these promoter libraries can be explored in combination with modified therapeutic payloads and capsids to provide gene therapy developers a solution that works across any range of cell or organism models. Similarly, the Circularis platform will give Ginkgo the ability to rapidly identify context-specific promoters for cell therapy applications, such as those that modulate gene expression in the tumor microenvironment.
"Circularis has built an exceptional platform to screen gene expression regulatory elements, a need across the cell and gene therapy space," said Narendra Maheshri, Head of Mammalian Foundry at Ginkgo Bioworks. "We are excited to leverage the strong expertise of the Circularis team to further develop circular RNA methods for therapeutic use, and can't wait to incorporate this technology into existing and upcoming cell programs across therapeutic applications as well as more broadly."
"Circularis was founded because we saw a need for better tools to control gene regulation in a range of species. Our team is incredibly proud of what we've built, and the opportunity to scale it on the Ginkgo platform means we're a major step closer to realizing this technology's potential," said Mat Falkowski, Chief Executive Officer at Circularis. "We are excited to bring the power of the Ginkgo platform to both Circularis' already existing customer base and future partners."
Circularis has been using the power of circRNA to control cells for the past eight years. Our novel biology has enabled new scales of experimental methods to help customers make advancements in gene therapy and treatment of rare diseases. Our advanced understanding of circular RNA across multiple cell types and organisms has guided our design towards a range of novel circular RNA materials for use in the growing field of RNA therapeutics.
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential success of the acquisition and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
GINKGO BIOWORKS INVESTOR CONTACT:
investors@ginkgobioworks.com
GINKGO BIOWORKS MEDIA CONTACT:
press@ginkgobioworks.com
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Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the tuck-in acquisition of Altar, a French biotechnology company that has developed a proprietary adaptive evolution platform. A fleet of Altar's automated adaptive laboratory evolution (ALE) instruments will be integrated into Ginkgo's Foundry to serve customers across food and beverage, biofuels, biomaterials, cosmetics, animal health and human health applications, among others. Ginkgo has successfully collaborated with Altar on customer programs historically and is excited to welcome them to the team.

Despite the immense progress in rational genome editing and high-throughput testing of engineered strains over the last decade, it often remains challenging to engineer microorganisms that meet target specifications under industrially relevant conditions due to the complexity and unknowns of the underlying genetics. For the development of certain phenotypes, such as those based on improved growth under normally unfavorable conditions, ALE can be a powerful approach to address this challenge. By incorporating Altar's ALE platform to Ginkgo's existing strain engineering capabilities, Ginkgo expects to be able to routinely engineer those target phenotypes that can be selected for based on their improved growth properties under defined process conditions, such as in the presence of otherwise inhibitory concentrations of a target end product or prohibitively high temperatures. Selected strains coming out of these ALE-based selections will then be characterized and further validated by Ginkgo's existing suite of test workflows.

"As the range of programs we work on continues to expand, it is imperative that we have the best tools in rational design as well as the ability to leverage the inherent diversity and creativity that emerges from evolutionary processes," said Nikos Reppas , Senior Director, Foundry Technology at Ginkgo Bioworks. "We're excited to welcome the Altar team to Ginkgo and look forward to integrating the Altar technology into Ginkgo's suite of offerings so we can better serve existing and future customers."
"We founded Altar to increase the feasibility and reduce time-to-market for bio-manufactured products," said Simon Trancart, CEO of Altar. "We've been working with Ginkgo for a few years now, and are thrilled to join the Ginkgo platform as we work to accomplish our mission at an even greater scale by collectively using biology to drive innovation across industries."
Altar is specialized in the development of microorganisms for industrial applications. Altar's technology, which was developed in collaboration with the French Alternative Energies and Atomic Energy Commission (CEA), automates Adaptive Laboratory Evolution and offers a unique capability to adapt microorganisms to the conditions required by industrial companies for their competitive utilization at commercial scale. Altar benefited from the support of the European Commission through the EIC Accelerator Pilot financing program. For more information, visit https://www.altar.bio/ .
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential success of the acquisition and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
GINKGO BIOWORKS INVESTOR CONTACT:
investors@ginkgobioworks.com
GINKGO BIOWORKS MEDIA CONTACT:
press@ginkgobioworks.com
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BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces that it has signed an agreement with Caris Life Sciences ® (Caris), a leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare.
"Our goal is to develop immunotherapies that are personalized for each patient, and Caris' extensive library of clinical data, cutting-edge biomarker technology, and expertise will be invaluable in achieving our objectives," stated Dr. Giuseppe Del Priore, BriaCell's Chief Medical Officer. "We expect Caris' unique platform to help us identify patients who do not respond to existing treatments and are more likely to benefit from our immunotherapy treatments."

Under the terms of the agreement, Caris will help BriaCell with efficient patient identification, accelerating enrollment for its current Phase I/II clinical trial in advanced metastatic breast cancer of certain genetically defined subgroups. The partnership between BriaCell and Caris leverages Caris' Right-In-Time (RIT) Clinical Trial Network, a group of over 495 oncology sites that are able to quickly identify and enroll eligible patients in biomarker-directed clinical trials. This service offers patients and physicians access to the most cutting-edge precision medicine in development. Additionally, through Caris' comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing), Caris will perform tumor profiling for the patients enrolled in the clinical trial.
About BriaCell Therapeutics Corp.
BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at https://briacell.com/ .
About Caris Life Sciences
Caris Life Sciences ^® (Caris) is the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare and improve patient outcomes. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced artificial intelligence (AI) and machine learning algorithms, Caris has created the large-scale clinico-genomic database and cognitive computing needed to analyze and unravel the molecular complexity of disease. This information provides an unmatched resource and the ideal path forward to conduct the basic, fundamental research to accelerate discovery for detection, diagnosis, monitoring, therapy selection and drug development to improve the human condition.
With a primary focus on cancer, Caris' suite of market-leading molecular profiling offerings assesses DNA, RNA and proteins to reveal a molecular blueprint that helps patients, physicians and researchers better detect, diagnose and treat patients. Caris' latest advancement is a blood-based, circulating nucleic acids sequencing (cNAS) assay that combines comprehensive molecular analysis (Whole Exome and Whole Transcriptome Sequencing from blood) and serial monitoring – making it the most powerful liquid biopsy assay ever developed.
Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Denver, Tokyo, Japan and Basel, Switzerland. Caris provides services throughout the U.S., Europe, Asia and other international markets. To learn more, please visit CarisLifeSciences.com or follow Caris on Twitter ( @CarisLS ).
Safe Harbor
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BriaCell's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading "Risks and Uncertainties" in the Company's most recent Management's Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under "Risks and Uncertainties" in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov . Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
Caris Life Sciences Media Contact:
Lisa Burgner
corpcomm@carisls.com
214-294-5606

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The White House today announced that President Biden intends to appoint Renee Wegrzyn PhD, as the first Director of the Advanced Research Projects Agency for Health ( ARPA-H ). Dr. Wegrzyn is currently the Vice President for Business Development at Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming. ARPA-H was established in March 2022 to drive transformative health breakthroughs that cannot readily be accomplished through traditional research or commercial activity.

"I am deeply honored to have the opportunity to shape ARPA-H's ambitious mission and foster a vision and approach that will improve health outcomes for the American people, including President Biden's Cancer Moonshot," said Dr. Wegrzyn. "Some of the problems we face every day – especially in health and disease – are so large they can seem insurmountable. I have seen firsthand the tremendous expertise and energy the U.S. biomedical and biotechnological enterprise can bring to solve some of the toughest health challenges. ARPA-H will create the transformative and collaborative space that is required to support the next generation of moonshots for health—not only for complex diseases like cancer, but also systemic barriers like supply chain gaps and equitable access to breakthrough technologies and cures for everyone."

Dr. Wegrzyn holds a PhD and BS in Applied Biology from the Georgia Institute of Technology , was a Fellow in the Center for Health Security Emerging Leaders in Biosecurity Initiative (ELBI), and completed her postdoctoral training as an Alexander von Humboldt Fellow in Heidelberg, Germany . Early in her career, she led research and development teams in private industry in the areas of biosecurity, gene therapies, emerging infectious disease, neuromodulation, synthetic biology, and diagnostics. She served as Program Manager in the Biological Technologies Office (BTO) of the Defense Advanced Research Projects Agency (DARPA), where she leveraged the tools of synthetic biology and gene editing to enhance biosecurity, support the domestic bioeconomy, and thwart biothreats. Since joining Ginkgo in August 2020 , she has built out its innovation pipeline for biosecurity, developing and scaling new tools to combat infectious disease and other biological threats through broad community access.
"This is a really great moment for health and biomedical innovation. Dr. Wegrzyn stands out as a thoughtful, innovative, and practical leader," said Matt McKnight , General Manager for Biosecurity at Ginkgo. "She understands the health innovation ecosystem from every angle—from early-stage research and development to commercialization and community impact, across the public, private, and academic sectors. In her time at Ginkgo, she has been an incredible leader, and her work has shaped the emerging biosecurity industry for years to come. Renee uniquely understands what is needed in the next era of invention, and ARPA-H will benefit tremendously from being shaped by her vision."
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .
This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
MEDIA CONTACT:
press@ginkgobioworks.com
INVESTOR CONTACT:
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-Represents second Phase 2 program for EP-104IAR, with initial data readout anticipated in H1, 2023-
Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced the initiation of a Phase 2 trial of EP-104IAR in adult patients afflicted with eosinophilic esophagitis (EoE), a rare disease that restricts the ability to swallow food and greatly impacts quality of life.
"EP-104IAR is designed to precisely deliver therapeutic levels of injected fluticasone propionate over an extended duration, which may help overcome some of the limitations of traditional oral steroids and provide longer and more stable disease remission and an improved quality of life for patients with EoE," said Dr. James Helliwell , CEO of Eupraxia.  "On that basis, we are initiating a Phase 2, open-label clinical study in adult patients with data from the trial expected to begin reading out in the first half of 2023."

The Company believes its drug delivery technology platform has the potential to be effective in EoE based on the proven efficacy of oral immediate release fluticasone propionate in this indication, and the growing library of data supporting the value of extended-release steroids in a variety of indications. The Company's technology is underpinned by a novel polymer membrane designed to release drug at a pre-defined rate, which could result in an effective, sustained treatment for EoE, improving patient outcomes.
Eupraxia has received regulatory clearance in Canada and the Netherlands , with responses pending from additional jurisdictions. The Company believes that this expansion of its clinical-stage pipeline represents the opportunity to further demonstrate the value of its platform across multiple indications. Eupraxia is continuing to pursue additional drug candidates and therapeutic targets, with a specific focus in oncology.
EoE is a chronic, immune mediated condition of the esophagus that causes inflammation, structural damage and dysfunction. It is characterized as an "orphan disease" – a rare condition that affects fewer than 200,000 people in the United States and/or 5 in 10,000 Europeans, and for which exists significant unmet medical need.
Current EoE treatment options (including diet changes, drugs such as proton pump inhibitors designed to help block acid build-up, and topical steroids that are swallowed to help reduce swelling and inflammation, and surgical dilation) often provide poor or only temporary control over the condition. Oral administration of steroids, including fluticasone propionate, can provide short-term relief, but prolonged use of these formulations, which are often prescribed off-label, leads to other conditions, such as candidiasis (thrush) in the mouth and esophagus, and ultimately poor patient compliance and disease control. In contrast, EP-104IAR poses the opportunity to inject long-acting fluticasone propionate directly into the affected tissues, with the potential for extended duration of effect, optimized drug kinetics and an improved safety profile.
EP-104IAR is currently being evaluated in a multi-centre European Phase 2 study focused on patients with osteoarthritis of the knee. This program includes significant and on-going pre-clinical data on EP-104IAR, allowing the EoE Phase 2 study to commence immediately in patients. The EoE study will assess the safety, tolerability and potential efficacy of endoscopically targeted injections of fluticasone propionate into affected areas of the esophagus. The Phase 2 trial in EoE will begin with a low dose to assess to pharmacokinetics of the delivery methodology. As the trial progresses, escalating doses may be given to optimize patient outcomes and duration of the treatment. The study will be conducted in multiple jurisdictions, including Canada and the Netherlands .
Eupraxia intends to pursue orphan drug status and any other mechanisms that could accelerate clinical testing and ultimate regulatory submission for EoE.
Eupraxia's lead product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting disease relief in multiple indications benefitting from highly localized and longer delivery of corticosteroids. The lead indication is for pain relief in knee OA. The U.S. Centers for Disease Control and Prevention estimates that knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer with knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can greatly affect quality of life.
With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. Current therapies are challenged by poor safety, inadequate efficacy and/or limited duration of activity. Corticosteroids are one of only two drug classes strongly recommended by the American College of Rheumatology and the Arthritis Foundation for the treatment of knee OA pain. Currently approved corticosteroids are very effective at reducing pain for a short duration late in the disease but can expose the body to unwanted local and systemic side effects.
EP-104IAR endeavours to provide long-term pain relief with fewer unwanted side effects. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane, part of Eupraxia's patented technology platform.
Injected into the knee, EP-104IAR is intended to diffuse drug slowly into the knee joint providing therapeutic concentrations for up to six months. This has the potential dual advantage of providing long-duration pain relief with fewer systemic side effects. An enhanced safety profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees by allowing simultaneous treatment of both affected joints.
In contrast to immediate release steroids, a non-clinical study of EP-104IAR suggests a cartilage sparing effect, which could provide a safer treatment alternative for those afflicted with chronic OA pain. The product has also been designed with physician convenience in mind – targeting a long shelf life, no refrigeration and easy integration into existing delivery techniques.
The potential advantages of EP-104IAR are central to the expansion into EoE and other indications. EoE is a localized inflammatory disease of the esophagus that has relied primarily on swallowing steroids (often off-label compounded versions) to control disease symptoms. Eupraxia hopes that a localized administration of an extended-release steroid will offer patients an effective treatment option that lasts for months instead of hours.
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release alternatives to currently approved drugs. Each of Eupraxia's product candidates has the potential to address therapeutic areas with high unmet medical need and strives to provide improved patient benefit by delivering targeted, long-lasting activity with fewer side effects.
Eupraxia's lead product candidate, EP-104IAR, is currently in Phase 2 development for the treatment of pain due to OA of the knee. The EP-104IAR platform is expanding into gastrointestinal disease with the launch of a program to treat EoE. In addition to EP-104IAR, Eupraxia is developing a pipeline of earlier-stage long-acting formulations. Potential pipeline candidates include a range of drugs for indications such as postsurgical pain (EP-105), and post-surgical site infections (EP-201), each designed to improve on the activity and tolerability of approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com .
This news release includes forward-looking statements and forward–looking information within the meaning of Canadian securities laws. Often, but not always, forward–looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes", "potential" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements in this press release include statements regarding the Phase 2 trial of EP-104IAR in patients afflicted with EoE, including the expected outcome of the Phase 2 trial, the expected timing of data from the Phase 2 trial and the receipt of regulatory clearance from additional jurisdictions; the potential and potential benefits of EP-104IAR; the Company's business strategies and objectives, including current and future plans and opportunities, expectations and intentions; statements regarding the Company's Phase 2 clinical trials; the ability of the Company to execute on its business strategy; the Company having sufficient resources, including anticipated funding from its current cash runway;  the potential of Eupraxia's product candidates; the Company's expectations regarding its product designs, including with respect to targeted shelf life, storage and ease of integration; the results gathered from studies of Eupraxia's product candidates; the potential for the Company's technology to impact the drug delivery process; the competitive advantages of the Company's technology; the benefits to patients from the Company's drug platforms; the translation of the Company's technologies and expansion of its offerings into clinical applications; the Company's estimation of potential product markets; and the demand and market acceptance for products developed by the Company. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward–looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of the COVID-19 pandemic on the Company's operations; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR ( www.sedar.com ). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement or information can be guaranteed. Except as required by applicable securities laws, forward–looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward–looking statement or information, whether as a result of new information, future events or otherwise.
SOURCE Eupraxia Pharmaceuticals Inc.

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GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to bring effective and safe solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person on our planet, today announced a realignment to focus on key near-term value drivers and extend its cash runway.
Key changes include further optimizing GreenLight's organizational structure to better serve the company's operations and more efficiently support the research, development and commercialization of its plant health and human health pipelines, primarily by integrating GreenLight's platform team into the respective teams for human health and plant health. These integrations come with a staff reduction of approximately 25%.

In recent months, GreenLight's human health team announced manufacturing mRNA at scale with Samsung Biologics and launched partnerships to develop vaccines with the Vaccine Research Center at the National Institutes of Health and with Serum Institute of India.
The plant health team has demonstrated first-of-a-kind field control of fungal pathogens such as Powdery Mildew, with effectiveness on a par with chemical standards. The team has also progressed work to develop RNA seed treatments, partnering with Germains Seed Technology. Field trials of GreenLight's proprietary pollinator solution to protect honeybees showed control of varroa destructor mite similar or superior to a leading chemical alternative after 12 weeks.
"Our goals, ambition and mission remain unchanged as we hone the focus of our work to current market conditions," said Andrey Zarur, CEO of GreenLight. "The integration and streamlining of teams will help extend our runway and allow us to better focus on our near-term value drivers for human health and plant health."
For plant health, we continue to work on broadening the pipeline, which includes fungicides and insecticides. There will be particular emphasis on advancing registration and commercialization of the first-ever foliar-applied RNA for crop protection, Calantha™, GreenLight's solution for control of the Colorado potato beetle. We will also continue towards regulatory submission of GreenLight's solution targeting varroa mites, which are decimating honeybee colonies around the globe.
For human health, our ongoing focus remains on obtaining proof of concept of GreenLight's technology platform with our Covid vaccine and advancing our shingles program in collaboration with Serum Institute of India. Following on the Covid and shingles work, GreenLight plans to continue to work on research programs addressing unmet medical needs in lower and middle income countries.
As a result of this realignment, GreenLight will shift its focus from early-stage research programs—including our gene therapy program for sickle cell disease and our programs for antibody therapy and supra-seasonal flu—to opportunities that are nearer to commercialization. We are also reorganizing our operations in order to maximize the efficiency of our team, which we expect will reduce our facilities and other SG&A costs over time. The reductions in headcount are expected to generate savings of approximately $13 million in direct employee costs in 2023. In addition, we expect there will be savings from other direct and indirect cost areas.
"This realignment comes following a range of cost cutting measures instituted earlier this year and will help us better position GreenLight for longer-term growth," said Andrey Zarur, CEO of GreenLight. "For me, personally, it is heartbreaking to say goodbye to such incredibly talented and valued colleagues and we sincerely appreciate their dedication and contributions to GreenLight."
About GreenLight Biosciences
GreenLight Biosciences (Nasdaq: GRNA) aims to address some of the world's biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The Company's platform is protected by numerous patents. GreenLight's human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review.
Availability of Other Information About GreenLight Biosciences
Investors and others should note that we communicate with our investors and the public using our website (www.greenlightbiosciences.com), the investor relations website (https://investors.greenlightbio.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that GreenLight posts on these channels and websites could be deemed to be material information. As a result, GreenLight encourages investors, the media, and others interested in GreenLight to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on GreenLight's investor relations website and may include additional social media channels. The contents of GreenLight's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Forward Looking Statements
Certain statements in this press release may constitute "forward-looking statements" for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the timing of and costs associated with our planned restructuring, and the benefits we expect to receive from the restructuring, the success, cost and timing of our research and development activities in our plant and human health programs, the acceptance of RNA-based technologies by regulators and the public, our ability to raise and productively deploy capital and the rate at which we can successfully bring products to market, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in our Quarterly Reports on Form 10-Q, periodic filings on Form 8-K, and any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. For additional information on GreenLight and potential risks associated with investing, please see our public filings at https://investors.greenlightbio.com/financial-information/sec-filings
Media Contact:
Thomas Crampton
SVP Corporate Affairs
GreenLight Biosciences
press@greenlightbio.com
Investor Contact:
investors@greenlightbio.com
https://investors.greenlightbio.com/
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Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), today announced the company will host a corporate update conference call and live webcast on October 18, 2022 at 2:00 p.m. Pacific Time 5:00 p.m. Eastern Time, to discuss the company's strategic review of its development pipeline.
Individuals interested in listening to the conference call may do so by registering via the webcast link in the investor relations section of the company's website at: www.ambrx.com .
To access the call by phone, please use the registration link on the investor relations section of the website, and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A webcast replay will be available in the investor relations section of the company's website for 90 days following the completion of the call.

About Ambrx Biopharma Inc. (Ambrx)
Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics. These include next generation antibody drug conjugates (ADCs), bispecifics, targeted immuno-oncology therapies, novel cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease. Ambrx is advancing a robust portfolio of clinical and preclinical programs designed to optimize efficacy, safety and ease of use, in multiple therapeutic areas, including its lead product candidate ARX788. In addition, Ambrx has clinical collaborations with multiple partners, for drug candidates generated using Ambrx technology. For more information, please visit www.ambrx.com .
Contacts
INVESTORS
Laurence Watts
Managing Director
Gilmartin Group, LLC.
619-916-7620
ir@ambrx.com
MEDIA
media@ambrx.com
Source: Ambrx, Inc.

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— Clean Safety Review from Data Safety Monitoring Board Supports Addition of Diabetes Patients into the Trial —
Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced updates to its Phase 2 trial which is evaluating EP-104IAR's efficacy and safety for the treatment of osteoarthritis ("OA") of the knee.
"A clean safety review from our Data Safety Monitoring Board has increased our confidence in EP-104IAR's potential as a treatment for OA of the knee and has allowed us to expand the scope of our Phase 2 trial," said Dr. James Helliwell , CEO of Eupraxia. "The updates we are announcing today have the potential to generate more robust data that could support a stronger Phase 3 trial for EP-104IAR, and further differentiate the product candidate's commercial profile in the longer-term. In addition, we believe that these updates increase EP-104IAR's opportunity to become an effective chronic treatment for a chronic disease. More than ever, we are excited about EP-104IAR's potential to treat OA, a disease with limited safe and effective treatment options that affects more than 30 million people in the U.S. alone."

Updates to the Company's Phase 2 trial include:
Eupraxia announced today that its ongoing Phase 2 study has successfully completed all DSMB reviews, with no drug-related Serious Adverse Events noted, and a clean safety profile.
The Company also announced today that based on the clean safety profile observed during the Data Safety Monitoring Board Review, it is now including patients with a diabetes diagnosis in its Phase 2 trial. Diabetics represent a meaningful percentage of patients diagnosed with OA, and inclusion of this important subgroup will provide valuable additional data to guide further drug development.
Magnetic Resonance Imaging ("MRI") has been added to the trial's protocol to further characterize the safety profile of EP-104IAR and could strengthen EP-104IAR's differentiation as a treatment for OA. This elective imaging component is expected to help identify EP-104IAR-induced reductions in inflammation and assess ongoing cartilage health in patients. Scans will follow patients at zero, three, six and 12 months, with a potential to include up to 50 patients. This change was implemented after the DSMB meeting and in conjunction with strong supportive pre-clinical evidence of cartilage health and joint health. The Company believes this MRI subgroup may further strengthen the pre-clinical data seen to date.
The Company also anticipates that this data will better inform its evaluation for inclusion of imaging in its planned Phase 3 program with the drug.
Dr. Helliwell commented, "We believe that a detailed visual representation of EP-104IAR's effect on knee osteoarthritis inflammation and joint morphology could be valuable in informing our Phase 3 trial design, and, on a longer-term basis, could better support physician decisions to prescribe the drug should it reach the commercial stage."
As a cumulative result of the updates to its Phase 2 trial, the Company anticipates that top-line data from the study will now be available in the second quarter of 2023. Eupraxia previously anticipated that the top-line data would read out in the first quarter of 2023.
Eupraxia's lead product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting disease relief in multiple indications benefitting from highly localized and longer delivery of corticosteroids. The lead indication is for pain relief in knee OA. The U.S. Centers for Disease Control and Prevention estimates that knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer with knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can greatly affect quality of life.
With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. Current therapies are challenged by poor safety, inadequate efficacy and/or limited duration of activity. Corticosteroids are one of only two drug classes strongly recommended by the American College of Rheumatology and the Arthritis Foundation for the treatment of knee OA pain. Currently approved corticosteroids are very effective at reducing pain for a short duration late in the disease but can expose the body to unwanted local and systemic side effects.
EP-104IAR endeavours to provide long-term pain relief with fewer unwanted side effects. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane, part of Eupraxia's patented technology platform.
Injected into the knee, EP-104IAR is intended to diffuse drug slowly into the knee joint providing therapeutic concentrations for up to six months. This has the potential dual advantage of providing long-duration pain relief with fewer systemic side effects. An enhanced safety profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees by allowing simultaneous treatment of both affected joints.
In contrast to immediate release steroids, a non-clinical study of EP-104IAR suggests a cartilage sparing effect, which could provide a safer treatment alternative for those afflicted with chronic OA pain. The product has also been designed with physician convenience in mind – targeting a long shelf life, no refrigeration and easy integration into existing delivery techniques.
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release alternatives to currently approved drugs. Each of Eupraxia's product candidates has the potential to address therapeutic areas with high unmet medical need and strives to provide improved patient benefit by delivering targeted, long-lasting activity with fewer side effects.
Eupraxia's lead product candidate, EP-104IAR, is currently in Phase 2 development for the treatment of pain due to OA of the knee. In addition to EP-104IAR, Eupraxia is developing a pipeline of earlier-stage long-acting formulations. Potential pipeline candidates include a range of drugs for indications such as postsurgical pain (EP-105), and post-surgical site infections (EP-201), each designed to improve on the activity and tolerability of approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com .
This news release includes forward-looking statements and forward–looking information within the meaning of Canadian securities laws. Often, but not always, forward–looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements in this press release include statements regarding the Company's business strategies and objectives, including current and future plans and opportunities, expectations and intentions; statements regarding the Company's Phase 2 clinical trial; the expected timing and potential of data to support and inform a planned Phase 3 trial; the ability of the Company to execute on its business strategy; the expected benefits of using MRI; the expansion of patient enrollment in the Company's Phase 2 clinical trial; the inclusion of diabetics in the Company's Phase 2 trial; the potential of Eupraxia's product candidates, including EP-104IAR's potential to treat OA; the Company's expectations regarding its product designs, including with respect to targeted shelf life, storage, ease of integration, duration and effectiveness; the results gathered from studies of Eupraxia's product candidates; the potential for the Company's technology to impact the drug delivery process; the competitive advantages of the Company's technology; the benefits to patients from the Company's drug platforms; the translation of the Company's technologies and expansion of its offerings into clinical applications; the Company's estimation of potential product markets; and the demand and market acceptance for products developed by the Company. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward–looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of the COVID-19 pandemic on the Company's operations; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR ( www.sedar.com ). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement or information can be guaranteed. Except as required by applicable securities laws, forward–looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward–looking statement or information, whether as a result of new information, future events or otherwise.
SOURCE Eupraxia Pharmaceuticals Inc.

View original content: http://www.newswire.ca/en/releases/archive/October2022/11/c1014.html
News Provided by Canada Newswire via QuoteMedia

— Cybin and The Chopra Foundation continue to work together to advance the research and education of psychedelic-based therapeutics as a new paradigm for the treatment of mental health —
Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics ^® , and The Chopra Foundation ("Foundation"), a not-for-profit organization dedicated to improving health and well-being founded by Dr. Deepak Chopra, join everyone in recognizing World Mental Health Day. The two organizations continue to work toward the research and education of psychedelic-based therapies and their role in enhancing well-being and consciousness.

According to the World Health Organization ("WHO"), over 900 million people are affected by mental illness around the world. The pandemic has increased the number of individuals that are affected by different forms of mental illness. In 2021 the WHO released data that over 280 million people were affected by depression.
"World Mental Health Day sends a reminder that our mental health is just as important as our physical health," said Doug Drysdale, Cybin's Chief Executive Officer. "At Cybin, mental health and well-being is at the center of everything that we do. It's this value that drives us to invest our energy and resources to discover new and innovative treatment options for mental health conditions. The commitment from organizations like The Chopra Foundation plays a critical role in this goal, and we are proud to partner with the Foundation to continue to educate and support what is possible for the treatment of mental health from psychedelics."
This year's World Mental Health Day theme is "Make Mental Health and Well-Being for All a Global Priority," and marks an opportunity for people with mental health conditions, advocates, governments, employers, employees and other stakeholders to come together to recognize progress in the field and to be vocal about what is needed to ensure mental health and well-being becomes a global priority for all. These initiatives are at the forefront of the work that Cybin and The Chopra Foundation are doing together to ensure that everyone has access to well-being resources, including those in underserved communities. An example of these initiatives is through The Chopra Foundation's Never Alone movement.
"The Chopra Foundation is committed to working with Cybin for creative and holistic solutions for alleviating the immense human suffering from mental disorders," said Deepak Chopra, The Chopra Foundation Founder, Chairman of the Board and Director. "Psychedelics research, creating support communities, emotional AI, and love in action through NeverAlone.love are just some of the areas we are working together on."
"On World Mental Health Day we recognize the urgency and desperate need to provide resources to those that are suffering. For that, we are grateful for the collaboration between Cybin and the Chopra Foundation, which is meaningful on multiple levels," said Poonacha Machaiah, Chief Executive Officer of The Chopra Foundation. "Mental health and longevity are core pillars of the Chopra Foundation, and we look forward to continuing to create an impact through our partnership with Cybin."
About The Chopra Foundation and Never Alone
The Chopra Foundation is a 501 (c) (3) organization (#36-4793898) dedicated to improving health and well-being, cultivating spiritual knowledge, expanding consciousness, and promoting world peace to all members of the human family. The Foundation's Never Alone movement will be providing the world with the tools to proactively pursue their path to joy and freedom from suffering.
About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221010005183/en/
Media Inquiries for The Chopra Foundation:
Kristen Marion
kristen@marionpr.com
623-308-2638

Investor & Media Inquiries for Cybin:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.com

Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-4601
News Provided by Business Wire via QuoteMedia

— Cybin and The Chopra Foundation continue to work together to advance the research and education of psychedelic-based therapeutics as a new paradigm for the treatment of mental health —
Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics ^® , and The Chopra Foundation ("Foundation"), a not-for-profit organization dedicated to improving health and well-being founded by Dr. Deepak Chopra, join everyone in recognizing World Mental Health Day. The two organizations continue to work toward the research and education of psychedelic-based therapies and their role in enhancing well-being and consciousness.

According to the World Health Organization ("WHO"), over 900 million people are affected by mental illness around the world. The pandemic has increased the number of individuals that are affected by different forms of mental illness. In 2021 the WHO released data that over 280 million people were affected by depression.
"World Mental Health Day sends a reminder that our mental health is just as important as our physical health," said Doug Drysdale, Cybin's Chief Executive Officer. "At Cybin, mental health and well-being is at the center of everything that we do. It's this value that drives us to invest our energy and resources to discover new and innovative treatment options for mental health conditions. The commitment from organizations like The Chopra Foundation plays a critical role in this goal, and we are proud to partner with the Foundation to continue to educate and support what is possible for the treatment of mental health from psychedelics."
This year's World Mental Health Day theme is "Make Mental Health and Well-Being for All a Global Priority," and marks an opportunity for people with mental health conditions, advocates, governments, employers, employees and other stakeholders to come together to recognize progress in the field and to be vocal about what is needed to ensure mental health and well-being becomes a global priority for all. These initiatives are at the forefront of the work that Cybin and The Chopra Foundation are doing together to ensure that everyone has access to well-being resources, including those in underserved communities. An example of these initiatives is through The Chopra Foundation's Never Alone movement.
"The Chopra Foundation is committed to working with Cybin for creative and holistic solutions for alleviating the immense human suffering from mental disorders," said Deepak Chopra, The Chopra Foundation Founder, Chairman of the Board and Director. "Psychedelics research, creating support communities, emotional AI, and love in action through NeverAlone.love are just some of the areas we are working together on."
"On World Mental Health Day we recognize the urgency and desperate need to provide resources to those that are suffering. For that, we are grateful for the collaboration between Cybin and the Chopra Foundation, which is meaningful on multiple levels," said Poonacha Machaiah, Chief Executive Officer of The Chopra Foundation. "Mental health and longevity are core pillars of the Chopra Foundation, and we look forward to continuing to create an impact through our partnership with Cybin."
About The Chopra Foundation and Never Alone
The Chopra Foundation is a 501 (c) (3) organization (#36-4793898) dedicated to improving health and well-being, cultivating spiritual knowledge, expanding consciousness, and promoting world peace to all members of the human family. The Foundation's Never Alone movement will be providing the world with the tools to proactively pursue their path to joy and freedom from suffering.
About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221010005183/en/
Media Inquiries for The Chopra Foundation:
Kristen Marion
kristen@marionpr.com
623-308-2638

Investor & Media Inquiries for Cybin:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.com

Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-4601
News Provided by Business Wire via QuoteMedia

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