GMP sgRNA from GenScript Powers Grit Biotechnology’s Cas12b-Based TIL Therapy GT307 to Receive FDA Clearance for Clinical Trials

Recently, Beijing Grit Bio officially announced,Its self-developed dual-gene knockout autologous TIL therapy GT307 has been approved by the U.S. Food and Drug Administration (FDA) for clinical research., used for the treatment of advanced solid tumors.

Genscript is highly honored to provide the core material GMP sgRNA for this approved TIL therapy, contributing to the cell therapy obtaining FDA clinical trial approval.Strongly support diversified cell therapies to bring benefits to more patients.Thus far,Genscript GMP sgRNA and HDR Gene Knock-in Templates Have Successfully Supported Customers in Obtaining 22 IND Approvals, with excellent product quality and comprehensive regulatory support, has accelerated customers' submission process, empowering cell therapy to move towards a broader market.

GT307 is a new generation of gene-knockout TIL product developed by Grail Bio.By knocking out two novel key immune regulatory genes, resistance to T-cell exhaustion and multiple immunosuppressive mechanisms in the tumor microenvironment was achieved, demonstrating significantly enhanced anti-tumor capabilities and in vivo persistence. This was accomplished using the independently developed high-throughput CRISPR screening platform, ImmuT Finder.^®Grail Bio has discovered and validated a series of key immune regulatory targets that influence the mechanism of action of TIL. The preliminary clinical data of GT307 has shown good safety, and patients with cold tumors can benefit from this drug.

Gravel Bio Utilizes Novel Gene Editor AaCas12b^MAXAchieving Dual-Gene Precise Knockout in TIL, to develop the next generation of gene-edited TIL products. Comparative research results on TIL cell gene editing show that AaCas12b^MAXDemonstrates significant advantages over the classical SpCas9 nuclease in terms of gene editing safety, product phenotype, and functionality. In accordance with FDA guidelines, Grail Bio has established a systematic and comprehensive safety evaluation system for gene-edited cell products, providing important reference for the FDA submission of such innovative products.

Relying on rich experience in supporting applications and a professional regulatory team,Genscript specializes in drafting submission documents for China and the U.S., providing solutions for supplementary advice.. At the same time, GenScript GMP sgRNA hasFDA DMF FilingAccelerated submission is possible. The robust product quality and professional regulatory support serve as dual drivers, making GenScript's GMP sgRNA an ideal choice for accelerating cell therapy development.

GenScript can provide170nt GMP sgRNA, supporting the development of cell therapies based on various cell types such as T cells, NK cells, and hematopoietic stem cells, as well as multiple editing systems including Cas9, Cas12, Base Editing, and Primer Editing. By December 2025, GenScript will have successfully deliveredMore than 200 batchesGMP sgRNA and Gene Knock-in Templates, SupportMore than 50 project applications, successfully passedMore than 40 audits, supporting global customers in obtaining22An IND Approval(Including12 CDE approvals, 8 FDA approvals, 1 EMA approval, 1 MEB approval), proudly leading the forefront of the GMP gene-editing nucleic acid raw materials industry, empowering the optimization, iteration, and globalization of cell therapy products.

GenScript Zhenjiang GMP Facility was constructed in compliance with the GMP facility requirements of major regulatory agencies such as the FDA, EMA, PMDA, and NMPA.Equipped with advanced environmental control systems, optimized aseptic product production equipment, and standardized personnel and logistics management, etc.Genscript will support rapid delivery with sufficient capacity, accelerate the progress of filings and clinical trials, and contribute to the efficient advancement of GCT companies' pipeline development and commercialization, helping gene and cell therapy benefit more patients.

Swipe left and right to browse GenScript Zhenjiang GMP Facility

Grit Biotechnology, established in 2019, is an innovation-driven biopharmaceutical company in the late clinical stage. It is committed to pioneering the next generation of immunotherapies for cancer and autoimmune disease patients worldwide. With deep insights into the field of immunotherapy, cutting-edge R&D and technology platforms, and world-class manufacturing capabilities, Grit Biotechnology has built multiple self-developed technology platforms in China and the United States. It also features a diversified R&D pipeline with several candidate products to address significant unmet clinical needs. GT101 Injection, independently developed by the company, is China’s first TIL drug approved for registrational clinical trials and has now entered a pivotal Phase II clinical trial. The self-developed GT201 Injection is the world's first TIL product incorporating a membrane-bound IL-15 complex, which has completed dual IND filings in China and the U.S. and has been approved to enter Phase I clinical trials. Additionally, the company has other highly innovative products, including a dual-gene knockout autologous TIL therapy, an mRNA vaccine targeting tumor neoantigens, the world’s first off-the-shelf CAR-iNKT cell therapy derived from stem cells, and next-generation in vivo CAR-T therapies. These form a product portfolio encompassing pan-solid tumor TIL drugs and off-the-shelf cell therapies. For more information, please visit: www.grit-bio.com.

Grit Bio is committed to overcoming the key limitations in current cancer and autoimmune disease treatments by driving three fundamental shifts to reshape the landscape of immunotherapy: from hematologic malignancies to solid tumors; from autologous therapies to off-the-shelf allogeneic therapies; and from ex vivo engineering to in vivo engineering. The goal is to revolutionize the treatment paradigm of immunotherapy through breakthrough research and development, ultimately fulfilling the company’s mission to provide patients worldwide with highly effective, affordable, and accessible treatment options.

About GenScript Biotech

Genscript Biotech Corporation (HK.1548) was founded in New Jersey in 2002. The company accelerates innovation in the biotechnology and healthcare fields by providing foundational research and development services needed to develop breakthrough treatments and products for researchers and enterprises. As a trusted global leading brand, Genscript is committed to the mission of "making people and nature healthier through biotechnology" and serves over 200,000 customers across more than 100 countries and regions with a team of over 5,700 employees worldwide.

For more information, please visit the GenScript website https://www.genscript.com

For more information about GenScript's GMP sgRNA and HDR gene knock-in template services, please contact GenScript's local sales or technical support:

Tel: 400-025-8686 ext 5812 or 5815

Email: oligo@genscript.com.cn