REDWOOD CITY, CA, June 3, 2024 –

Synthego introduces hfCas12Max, a high-fidelity CRISPR enzyme developed by HuidaGene Therapeutics and licensed exclusively by Synthego, designed to advance therapeutic genome editing with superior precision and efficiency. An enhanced alternative to traditional CRISPR nucleases, hfCas12Max is already being utilized in clinical trials, underscoring its potential in advancing real-world therapeutic applications. With this novel CRISPR solution, Synthego has streamlined the licensing process to make it more efficient and cost-effective, allowing developers quick and easy access to this cutting-edge technology for advancing their therapeutic programs.

The innovative hfCas12Max CRISPR enzyme is specifically engineered for applications requiring exceptional accuracy, such as gene and cell therapy development. By minimizing unintended edits while retaining robust on-target activity, hfCas12Max meets the stringent demands of translational research and therapeutic programs. Paired with Synthego's best-in-class gRNAs, optimized for seamless integration with hfCas12Max, this novel system ensures consistent and high-quality results that meet the rigorous demands of clinical applications.

Synthego's offering underscores its commitment to enabling therapeutic innovation and driving advancements in the life sciences industry. By pairing advanced genome editing tools like hfCas12Max with tailored sub-licensing solutions, the company is helping researchers and developers accelerate progress toward groundbreaking therapies. For more details on hfCas12Max, sub-licensing opportunities, and Synthego's specialized gRNAs, visit the hfCas12Max product page or chat with our CRISPR experts.

REDWOOD CITY, CA, March 27, 2024 –

"Founding and growing Synthego the past 12 years has been the privilege of a lifetime," said Dabrowski. "Our team has transformed the CRISPR landscape by staying true to our values and providing everyone, from individual scientists to the world’s leading biotechnology companies, with unprecedented access to advanced genome engineering. I’m confident Craig is an ideal fit to further our mission by building a robust commercial engine leveraging Synthego’s platform - in addition to his impeccable track record, he embodies Synthego’s culture of innovation and excellence. As the world enters the era of CRISPR based therapeutics, Synthego is now focused to be the premier supplier to hundreds of programs entering the clinic."

Christianson has a track record of spearheading global commercial strategies, business development and operations to build global life sciences and other businesses. He joins Synthego from Water Street Healthcare Partners, preceded by 12 years with global biotechnology company Promega Corporation where he led commercial operations, accelerating their growth to 00M+ in annual sales through profit-driven strategies and successful digital transformation.

"I am honored to join this pioneering organization which plays an important role in the impact CRISPR has on life science research and clinical development," said Christianson. "Paul is a visionary who has built a foundation upon which Synthego will become the best partner for clients in terms of co-development and regulatory compliance for the advancement of therapies and, ultimately, human health."

Christianson’s appointment, along with the spinout of EditCo Bio, previously operating as Synthego’s Eclipse platform, reinforces Synthego’s commitment to provide CRISPR therapeutic developers with best-in-class guide RNAs. With its state-of-the-art GMP facility and extensive experience of producing leading products, Synthego is uniquely positioned to address escalating clinical requirements and changing regulatory frameworks. Bolstered by the FDA approval of the first CRISPR-based therapy, Synthego is more dedicated than ever to accelerating life-saving technologies for improved human health in its next chapter. 
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REDWOOD CITY, CA, March 27, 2024 – EditCo Bio, Inc. announced that it has launched its business with the acquisition of Synthego’s engineered cell solutions and enhanced guide RNA business. Borne from Synthego’s cell engineering expertise, EditCo is uniquely positioned to deliver edited cells and highly optimized guide RNA designs for the rapidly expanding CRISPR market. EditCo will operate as an independent business with financing and support from life sciences investment firm Telegraph Hill Partners.

EditCo will offer researchers simple one-click access to high-quality engineered cells with guaranteed edits in their desired targets, minimizing time and effort spent in experiments. By ushering in unprecedented predictability in biology, EditCo lays the foundation for rapid outcomes in basic biology and cell and gene therapy research. As an independent entity, EditCo will have the flexibility to invest in and scale up its capabilities to best meet the needs of its global customers. The company plans to launch new products and services, expand commercial operations and continue to build on its leadership position in cell engineering.

EditCo will be led by former Synthego President and Chief Operating Officer, John Tan, who has been appointed Chief Executive Officer. Travis Maures, PhD, former Chief Technology Officer of Synthego will be Chief Scientific Officer of EditCo. "EditCo begins its journey with the benefit of significant investment in our cell engineering capabilities while part of Synthego," said John Tan. "Our proven products and manufacturing operations enable us to immediately serve customers with industry-leading CRISPR solutions and world-class customer support."

"CRISPR continues to demonstrate its power to accelerate progress across the drug discovery pipeline and will ultimately lead to more and better validated drugs entering the clinic," said Travis Maures. "EditCo’s products and manufacturing operations have already been proven within Synthego, enabling us to immediately initiate commercial operations and deliver validated, customer-focused solutions that provide industry-leading gene editing efficacy and reproducibility."

As an independent company, EditCo will establish unique partnerships, invest in new product innovation, and pursue strategic investment opportunities. To support its operations and growth initiatives, EditCo has closed a financing from Telegraph Hill Partners. This funding strengthens the company's ability to create long-term value and align with the unique customer needs across both basic research and preclinical phases of CRISPR-based therapy development.

EditCo is based in Redwood City, California and can be found online at www.EditCo.bio.

Redwood City, CA & Waltham, MA, January 23, 2024 – Synthego, a leading provider of genome engineering solutions, and SeQure Dx, a company focused on off-target analysis for preclinical and clinical gene modification customers, have announced a strategic partnership to provide CRISPR-based therapeutics developers with comprehensive off-target editing analytical services that include best-in-class technology and turn-key end-to-end development solutions.

This partnership furthers Synthego’s mission to empower therapeutics developers by offering access to a comprehensive solution for every phase of CRISPR-based therapeutic development and connects SeQure Dx’s portfolio of off-target technologies with Synthego’s unique continuum of synthetic RUO-to-GMP guide RNAs, industry-leading regulatory expertise for CRISPR-based therapeutics, and extensive commercial infrastructure. The pairing of these capabilities ensures that more gene editing companies will have access to gold-standard assays to safely develop potentially life-saving therapeutics.

The cornerstone of SeQure’s platform highlighted in this new offering is the ONE-seq assay, a technology developed by Keith Joung and his lab at Massachusetts General Hospital. Through this unique partnership, therapeutic developers can achieve a more streamlined and efficient therapeutic development process, working with a single provider for both their synthetic gRNA solutions and off-target analyses, reducing the risk of errors and delays and providing the most comprehensive off-target identification solution available.

"We are excited to partner with SeQure Dx to provide our customers with a comprehensive solution for their CRISPR-based therapeutic development needs," says Eleanor Kolossovski, Synthego Vice President of Commercial. "This partnership aligns with our mission to empower researchers and developers with the tools and resources they need to bring safe and efficacious therapies to patients."

SeQure Dx's ONE-seq technology is the most sensitive and the only universal off-target nomination method available that can account for the impacts of genetic variability at scale. Access to this unique capability ensures that investigators can have a more accurate and comprehensive understanding of off-target effects, informing internal strategic pipeline decisions, reducing regulatory risk, and improving the overall safety of their therapeutic products.

"SeQure's best-in-class off-target nomination assays and confirmation platforms will seamlessly complement Synthego's end-to-end CRISPR-based portfolio of products and services," says SeQure Dx founder Keith Joung. "This partnership should provide CRISPR-focused therapeutics developers with access to an all-in-one solution for their preclinical and clinical needs."

Regulatory agencies consider off-target analysis critical for developing therapeutic products, making this partnership a valuable asset for researchers and developers. Synthego has supported 16 IND submissions, of which 8 have been approved by the FDA, underscoring Synthego’s commitment to understanding, interpreting, and addressing the evolving regulatory guidelines for CRISPR therapeutics developers during and after the IND submission process. With Synthego and SeQure Dx's combined expertise and resources, therapeutic developers can have greater confidence in the safety and efficacy of their CRISPR-based therapies throughout development.

For more information on Synthego and SeQure Dx's partnership and offerings, please visit Synthego.com/off-target-editing-analysis.

REDWOOD CITY, CA, October 4, 2023 – Synthego, a leading provider of genome engineering solutions, has announced the launch of its IND-enabling (INDe) gRNAs, a transformative product offering that revolutionizes the CRISPR-based cell and gene therapy preclinical pipeline. This innovative offering empowers researchers with high-quality gRNAs designed specifically for GLP-regulated preclinical and IND-enabling studies, incorporating comprehensive IND-compliant materials and documentation in their design and production and facilitating a seamless transition from preclinical to clinical applications.

"IND-enabling gRNA is the culmination of years of learning at Synthego to understand how CRISPR is used in preclinical and clinical applications in order to provide end-to-end support for cell and gene therapy developers," said Paul Dabrowski, CEO of Synthego.

On the journey through the regulated landscape of CRISPR-based therapeutic development, every step counts towards realizing groundbreaking ideas for life-changing therapies. The IND-enabling phase plays a pivotal role, involving rigorous safety, toxicity, and efficacy testing of the therapeutic candidate, along with initial interactions with health regulators. This phase culminates in the submission of the Investigational New Drug (IND) application, paving the way for clinical trials.

The introduction of INDe gRNAs enhances Synthego’s industry-leading coverage of the entire discovery-to-clinic continuum when combined with Synthego’s recently inaugurated cutting-edge GMP facility, bolstering its support for the rapidly expanding CRISPR clinical industry. This expansion ensures customer success throughout the entire therapeutic development process. Leveraging Synthego's proprietary Halo™ platform, a holistic system encompassing hardware, automation, chemistry, and dynamic learning models, each gRNA product within Synthego’s continuum is precisely tailored to meet the unique requirements of researchers at each phase of therapeutic development.

For more information, please visit www.synthego.com/inde.

Redwood City, CA and Cambridge, UK, August 24, 2023: Synthego, a leading provider of industrialized genome editing solutions that accelerate discovery to clinic journey, and bit.bio, the company coding human cells for novel cures, today announced a strategic partnership to build a platform centered on the implementation of synthetic circuitry in cells for therapeutic application.

bit.bio is building a pipeline of cell therapies focused on areas of unmet clinical need. The partnership will apply Synthego’s expertise in gene editing to bit.bio’s opti-oxTM precision cell programming technology, with the aim of discovering and developing advanced genetic engineering solutions for cell therapies.

Synthego will rapidly design, build, test and deliver an end-to-end optimized multiplexed genetic editing strategy. The implementation of the multiplexed opti-ox engineering approach will reduce the number of engineering steps required, with the potential of shortening clinical cell engineering and development timelines by up to 10 months.

"bit.bio is the leading synthetic biology company focussed on human cells. We are thrilled to deepen our partnership with bit.bio to facilitate a leap forward in the development of synthetic biology-based cell therapies," said Paul Dabrowski, CEO at Synthego. "By coordinating our respective technologies, expertise and resources, we will unlock new opportunities for addressing critical challenges in the field by advancing the R&D cycle of innovative cell therapies."

"Synthego are experts when it comes to industrialized cell engineering," stated Mark Kotter, CEO at bit.bio. "Teaming up with Synthego will boost our genetic engineering capabilities. We expect efficiency gains across bit.bio’s platform which will allow us and our partners to deliver transformative therapies more rapidly to patients in need."

REDWOOD CITY, CA, June 28, 2023 - Synthego, a leading genome engineering company, is pleased to announce a groundbreaking partnership with ATCC, the premier non-profit global biological materials and standards resource center, to provide researchers with an extensive collection of mammalian and mouse cell lines for gene editing applications, including Express Cell Pools to increase speed to results.

This alliance brings together Synthego's expertise in genome engineering and ATCC's renowned reputation as a trusted provider of authenticated biological materials and standards. CRISPR-edited cell pools are indispensable tools for many research applications, from disease modeling to loss-of-function screens and drug discovery. By leveraging Synthego's innovative CRISPR solutions and ATCC's vast cell line collection, researchers will gain unparalleled access to a comprehensive range of cell models and invaluable scientific resources, accelerating research breakthroughs and advancing the field of genetic engineering.

Synthego's Gene Engineering Platform, powered by advanced CRISPR technology, enables precise and efficient gene editing, enabling scientists to unlock the full potential of their research. The collaboration will facilitate the expedited delivery of genome edited cell lines specifically tailored for drug discovery applications. Additionally, this will ensure that researchers can have timely access to a diverse array of fully characterized and validated mammalian and mouse cell lines, meeting the highest standards of quality and reproducibility.

"We are thrilled to join forces with ATCC to provide researchers with cutting-edge CRISPR tools and resources for obtaining edited cell pools that can be used directly in many assays," said Paul Dabrowski, CEO of Synthego. "Researchers now have the option to skip labor-intensive genome engineering in their lab, in many cases also avoid months of waiting for clones, and instead leverage Synthego Engineering of ATCC cells."

"Together with Synthego, we're enabling disease modeling at scale, and enabling discovery and validation with ease and speed," said Raymond H. Cypess, D.V.M., Ph.D., chairman and CEO of ATCC. "We are committed to continuing to be a foundational player in the biotechnology industry as our biomaterials are critical to expanding global research and development pipelines."

Both ATCC and Synthego are committed to fostering innovation and collaboration in the life sciences industry. The combined expertise of Synthego and ATCC will empower scientists, accelerate scientific breakthroughs, and contribute to the development of novel therapeutics, diagnostic tools, and precision medicine solutions.

For more information about Synthego's innovative Cell Line Engineering and gene editing solutions, please visit www.synthego.com. To explore ATCC's extensive collection of cell lines and biological materials, please visit www.atcc.org.

REDWOOD CITY, Calif., May 17, 2023, Synthego Corp., a leading provider of genome engineering solutions, has announced a victory in its dispute with Agilent Technologies, Inc., regarding two of Agilent’s patents which have been invalidated today by a ruling of the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office.

The PTAB ruled in favor of Synthego’s petitions seeking to invalidate Agilent’s US Patents Nos. 10,337,001 (the ’001 patent) and 10,900,034 (the ’034 patent) in the Inter Partes Review before the PTAB.

The PTAB's decision invalidates all claims of the Agilent patents, which were directed to guide RNAs having at least one 2’-O-methyl modification (‘034 patent) and guide RNAs having certain modifications within 5 nucleotides of their 5’ and/or 3’ end (‘001) patent), as well as methods of using such modified guide RNAs for CRISPR gene editing.

Synthego is pleased with the PTAB's ruling, which paves the way for continued innovation in the field of CRISPR-enabled research and therapeutics. By delivering cutting-edge genome engineering solutions, Synthego empowers researchers and contributes to the advancement of CRISPR genomic medicines.

"This decision by the PTAB is a major victory for the entire CRISPR-enabled research and therapeutics field," stated Paul Dabrowski, CEO of Synthego. "The ruling confirms that the invalidated Agilent patents attempted to claim well-known modifications to guide RNAs already taught by prior art. It is a win for researchers and, ultimately, for patients."

REDWOOD CITY, Calif., May 11, 2023, Synthego Corp., a leading provider of genome engineering solutions, announced today the opening of its state-of-the-art GMP synthesis facility. This new 18,000 square-foot facility supports the growing demand for development of high-quality, CRISPR-enabled in vivo and ex vivo therapeutics by pharma and biopharma clients, including via IND and NDA or BLA enabling clinical studies.

The new facility follows current Good Manufacturing Practices (cGMP) and features 24/7 operations with advanced equipment and technologies, including multiple multiplexed manufacturing lines, fully automated controls, and an integrated Manufacturing Execution System (MES). This enables the company to produce a range of oligonucleotides, including synthetic single guide RNAs, setting the standard for quality and compliance in manufacturing gene editing components. The facility also includes dedicated process development, analytical testing, and quality control areas, ensuring that all aspects of the manufacturing process are closely controlled.

"This facility will be essential in supporting the burgeoning field of clinical phase, first-in-human, CRISPR-enabled medicines both for more common genetic diseases but also for rare diseases affecting children for whom other treatments do not exist for," said Adrian Thrasher, M.D., Ph.D., a Clinician and Professor of Pediatric Immunology at University College London Great Ormond Street Institute of Child Health, whose laboratory is developing new CRISPR-enabled medicines for children with rare genetic diseases. "As we move into this new generation of cell and gene therapies, it will be crucial that there are strong, reliable manufacturing capabilities that exist for the necessary components of the CRISPR technology - such as the guide RNA - in order to accelerate the path to clinic and treat patients."

Don Kohn, M.D., Distinguished Professor and Clinician of Pediatric Hematology and Oncology at UCLA, whose laboratory pioneered revolutionary genetic therapies for immunocompromised children, added, "Synthego pioneered the mass production of guide RNAs for discovery research that has enabled many of the CRISPR-based cell and gene therapy trials happening today. Having been a key leader in providing the technology for researchers and clinicians, it follows that they are now expanding their capacity to support this research as it translates into the clinic."

The new facility has been designed to meet the requirements of both domestic and international regulatory authorities including the FDA, EMA, MHRA, and Health Canada.

"We are pleased to open Synthego’s new GMP facility, solidifying our commitment to provide partners with the highest quality CRISPR guides for the clinical development of therapeutics. This represents a significant step towards removing industry bottlenecks and helping accelerate access to life-changing and lifesaving CRISPR-enabled cell and gene therapies." said Paul Dabrowski, CEO of Synthego. "The design of this facility is the fruition of a decade of experience creating guide RNAs and engineering cells, and sets the standard for quality and efficiency of GMP CRISPR reagent manufacturing."

Synthego offers industry-leading, high quality synthetic guide RNAs in three different classes, research grade, GMP-like, and GMP, to support all stages of the therapeutic development process from bench through clinic. With the opening of this facility, Synthego is well-positioned to meet the strong customer demand for custom manufacturing of RNA molecules for development of cell and gene therapeutics, and to continue to provide clients with the highest quality products and services.

For more information about Synthego's new GMP facility, visit www.synthego.com/gmp.

REDWOOD CITY, Calif. - Synthego Corp., a leading provider of genome engineering solutions, has announced the launch of Express Knockout Cell Pools, a new product offering that revolutionizes access to CRISPR-mediated gene editing by providing researchers access to a more efficient and more reliable approach to obtain knockout cell pools at unparalleled speed and scale.

CRISPR-edited cell pools are indispensable tools for many research applications, from disease modeling to loss-of-function screens and drug discovery. Bypassing the researcher’s need to design, optimize and execute a CRISPR workflow, Express Knockout Cell Pools will disrupt how researchers think about their CRISPR-editing needs. Skipping the time-consuming task of clonal isolation and directly running functional assays in these cell pools will enable researchers to generate the results they need for their next publication or project milestone confidently and in a fraction of the time.

Express Knockout Cell Pools deliver several advantages, including:

• Increased speed to results: Delivery time has been reduced to 3 weeks or less, almost three times faster than the average experimental duration of a CRISPR workflow reported by researchers (CRISPR Benchmark Report).
• Increased confidence in results: Express Knockout Cell Pools use Synthego’s proprietary multi-guide technology to target protein-coding genes, increasing editing efficiency and maximizing the likelihood of functional knockout. This results in higher success rates and more reliable data compared to other editing approaches.
• Reproducible results: Every Express Knockout Cell Pool includes a comprehensive quality control (QC) report with detailed information on the sgRNAs used, PCR primers, editing efficiency, and more, enabling researchers to make informed decisions about downstream assays.
• Scalability: The high throughput of Synthego’s cell engineering platform enables researchers to broaden the scope of their projects without limits, providing easy access to as many cell models as they need at an affordable price.

"Synthego is committed to simplifying the use of CRISPR and speeding up R&D efforts," said Paul Dabrowski, CEO of Synthego. "With the launch of our new product line, Express Cell Pools, we offer an affordable, fast, efficient, and reliable way for researchers to obtain edited cell pools that can be used directly in many assays. Researchers now have the option to skip labor-intensive genome engineering in their lab, in many cases also avoid months of waiting for clones, and instead leverage Synthego Engineered cells to increase confidence in their studies by discovering and validating more targets than ever before with ease and speed."

Synthego's Express Knockout Cell Pools are the newest addition to Synthego’s comprehensive Engineered Cells product portfolio and the result of significant improvements across Synthego's Eclipse platform. With an expanding menu of immortalized human and mouse cell lines and Synthego’s multi-guide designs available for the whole human and mouse exomes, customers can easily customize their product and obtain as many cell models as they need for their research workflow, from drug discovery and cell and gene therapy applications to pathway analysis and basic research.

With a focus on precision, efficiency, and reliability, Synthego's products enable researchers to conduct cutting-edge research. For more information about Express Knockout Cell Pools, visit synthego.com.