On December 9, 2024 GenScript Biotech, a global biotechnology leader in the life science, biologics manufacturing, synthetic biology, and cell therapies, and its partner, Base Therapeutics, reported the FDA approval of its NK510 program’s IND (Press release, GenScript, DEC 9, 2024, View Source [SID1234648964]). The NK510 cell program is an NK cell therapy for the clinical treatment of advanced solid tumors, and uses GenScript’s cGMP sgRNA to perform base editing, with CytoSinct Cell Isolation Nanobeads (GMP) and CytoSinct 1000 instruments to perform cell isolation. This is the first FDA IND approval of a base-edited NK cell program and follows NK510’s clinical trial approval by China’s NMPA in October 2024.

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"I am honored that Base Therapeutics has partnered with GenScript to advance the AccuBase Edited NK Cell Therapy project, NK510, which has successfully received IND approval in both the United States and China," remarked Dr. Tianhong Xu, founder of Base Therapeutics. "We are grateful to GenScript for providing services and products (sgRNA & instruments) that meet the regulatory requirements of both countries. This achievement not only marks a significant breakthrough in base editing technology, but also underscores our unwavering commitment to innovation, safety, and efficacy."

"GenScript congratulates Base Therapeutics on their remarkable achievements. We are proud to be the sole provider of their RUO to cGMP sgRNA material and cell isolation platform, essential for reliably generating accurately base-edited cells throughout the product development process," said Dr. Ray Chen, President of the Life Science Group at GenScript. "This collaboration underscores GenScript’s capabilities in supporting gene and cell therapy clients in achieving global IND approvals in an expedited timeline, ultimately helping them make innovative therapies more accessible worldwide."

NK510 is a universal "off-the-shelf" allogeneic NK cell program independently developed by Base Therapeutics. It leverages AccuBase, a proprietary zero off-target base editor with global freedom to operate (FTO) protection, to precisely modify key genes in NK cells, achieving over 90% editing efficiency.

GenScript’s GMP Guide RNA: Enabling Diversified Cell Therapies

With 22 years of expertise in nucleic acid synthesis, GenScript has built a comprehensive gene editing portfolio with RUO to cGMP grade materials, including chemically synthesized guide RNA (gRNA) and HDR knock-in templates. "We can produce cGMP gRNA up to 140 nucleotides long at gram-scale quantities, enabling a wide range of editing technologies, including Cas9, Cas12a, base editing, and prime editing," said Dr. Jianpeng Wang, Senior Director of GenScript’s GMP Production Department. "We also support the preparation of submission materials for regulatory agencies in the US, EU, and APAC markets. This combination of superior product quality and extensive regulatory experience makes GenScript an ideal partner for accelerating cell therapy development."

As of May 2024, GenScript has successfully delivered over 120 batches of cGMP gRNA and HDR knock-in templates, supported more than 40 regulatory submissions, passed over 30 audits, and helped global clients obtain 13 IND approvals.

GenScript’s CytoSinct Platform: Enabling Precise Nanobead-Based Cell Isolation

The CytoSinct Cell Isolation Nanobeads leverage advanced nanoparticle-empowered immuno-magnetic isolation technology to enrich specific cell populations of interest. Its expertise in antibody development and magnetic bead production ensures high precision and reliability. The CytoSinct 1000 Instrument complements the nanobead technology with automation for large scale processing and is designed with 21 CFR Part 11 compliance, adhering to FDA regulations for electronic records and e-signatures to safeguard data integrity throughout the cell isolation process. With customizable programming and alert functions streamline the operation, the system streamlines operations and ensures efficient and reliable automated cell isolation. The CytoSinct platform has also completed FDA DMF filing, underscoring its readiness for clinical applications.