GenScript Biotech and T-MAXIMUM Biotech Form Strategic Alliance on cGMP sgRNA

10 August 2023 | Thursday | News

GenScript's cGMP sgRNA reagent services enabled FDA-certified orphan drug designation (ODD) for T-MAXIMUM Biotech's MT207 CAR-T cell therapy
Image Source : Public Domain

Image Source : Public Domain

 GenScript Biotech, the world's leading life-science research tools and services provider, and T-MAXIMUM Biotech, a biotechnology company pioneering universal cell therapies, have formed a strategic collaboration agreement to enable the development of T-MAXIMUM's development CAR-T cell therapy using GenScript's CRISPR nucleic acid reagents.

GenScript will provide T-MAXIMUM Biotech with various CRISPR reagents to support the development of its universal CAR-T products from discovery to commercialization. The partnership with GenScript will support T-MAXIMUM Biotech's strategic development plan to progress multiple products to the Phase II clinical research stage and deliver products to market within the next five years.

Dr. Shang Xiaoyun, CEO of T-MAXIMUM, said: "We are delighted to establish a strategic cooperation with GenScript. T-MAXIMUM focuses on recurrent high-grade gliomas without effective standard therapies and is committed to the development of universal CAR-T cell therapies. Gene editing reagents are crucial raw materials for the quality and efficacy of our products. We are confident that this collaboration will accelerate the regulatory processes in China and the United States, expediting T-MAXIMUM's first product pipeline to benefit patients in need as soon as possible."

"We are honored to collaborate with T-MAXIMUM Biotech," said Dr. Li Hong, VP of R&D and manufacturing at GenScript. "Our R&D-to-GMP-level sgRNA will support their UCAR-T products for solid tumors. While CAR-T cell therapies have made remarkable strides in hematological tumors, addressing the unmet need for solid tumors remains crucial. We look forward to the further achievements of T-MAXIMUM Biotech's cell therapy products—and to bringing good news to more patients."

T-MAXIMUM Biotech targets solid tumors with universal cell therapy

T-MAXIMUM Biotech is a clinical-stage cell therapy development company with core technology published in top journals such as NatureNature BiotechnologyNature Methods, and Cell. Its universal CAR-T cell therapy product, MT027, is being developed for the treatment of recurrent high-grade gliomas. T-MAXIMUM Biotech uses the CRISPR system and electroporation RNP technology to knock out the TRAC and HLA genes, eliminating GVHD and TCR receptor signal interference, reducing rejection reactions, and prolonging the survival time of CAR-T cells in the body.

In February of this year, based on comprehensive preclinical research and positive results from investigator-initiated clinical studies (IIT), T-MAXIMUM Biotech's MT027 obtained FDA ODD certification — a breakthrough milestone in T-MAXIMUM's mission to "solve the treatment of diseases with no available drugs."

FDA's certification of orphan drug designation (ODD) to T-MAXIMUM Biotech

In June of this year, the latest clinical research data of MT027 was presented at the American Society of Clinical Oncology (ASCO), further validating the feasibility of the product:

  • Safety: no severe CRS or ICANS occurred, no GvHD was observed, and all adverse events were grade 1-2.
  • Efficacy: disease control rate (DCR) was 100%, objective response rate (ORR) was 42.9%, and the 12-month survival rate after relapse was 85.7% — significantly higher than historical data of 14%.

GenScript's GMP sgRNA service supports ODD

With 20 years of expertise in nucleic acid synthesis, GenScript has developed optimized processes, strict quality control, and extensive expertise in establishing a complete research-to-cGMP level CRISPR nucleic acid reagent product line. GenScript has supported seven successful IND approvals for gene and cell therapy (GCT) projects worldwide based on CRISPR technology and is committed to accelerating the development and commercialization process of GCT companies to the benefit of more patients.

GenScript offers one-stop chemical synthesized  sgRNA and non-viral HDR knock-in templates, including GenExact linear ssDNA, GenWand linear closed-end dsDNA, and GenCircle circular miniature dsDNA, enabling high editing efficiency, low cytotoxicity, and low off-targets. From research use only to cGMP-quality products, GenScript aims to provide fast and quality services to meet the needs of cell- and gene-therapy researchers at different stages and to accelerate development of this area of fast-growing sector.


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