Synthego and SeQure Dx Partner to Provide Comprehensive Off-Target Analysis Services for CRISPR-Based Therapeutics Developers

REDWOOD CITY, Calif. and WALTHAM, Mass., Jan. 23, 2024 /PRNewswire/ -- 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.

About Synthego:

Synthego is a pioneering provider of genome engineering solutions, offering a comprehensive suite of products and services to accelerate CRISPR-based cell and gene therapy development. With a commitment to empowering researchers and innovators, Synthego's cutting-edge technologies and expertise drive progress from preclinical to clinical application. To learn more, visit synthego.com.

About SeQure Dx:

SeQure Dx is a genomics intelligence company dedicated to the advancement of gene editing and cell therapies from discovery to patient. SeQure's initial preclinical platforms for the biopharma industry, NoteSeQ and ScopeSeQ, comprise a suite of proprietary, best-in-class diagnostic assays and bioinformatic analytics that span the spectrum of off-target nomination and confirmation. The NoteSeQ and ScopeSeQ platforms comprehensively solve our partners' preclinical off-target evaluation needs, including guide selection and IND submissions. SeQure Dx's goal is to help ensure that gene editing and cell therapies are developed for all patients who would benefit from this next generation of life-saving technologies. For more information, please visit sequre-dx.com.

SOURCE Synthego