News & Activities » GenScript ProBio Congratulates XLifeSc on FDA Allowance of IND Application for TCR-T Program

On September 24, XiangXue Life Sciences (XLifeSc), a partner of GenScript ProBio, announces FDA allowance of its IND application for TCR-T program (TCRT-ESO-A2). GenScript ProBio extends congratulations on this.

This program is China's first TCR-T program targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients. On June 10, 2019, GenScript ProBio and XLifeSc announced a strategic partnership agreement with regard to the development and manufacturing of vectors for cell therapy. Under the agreement, as a major technical service provider for XLifeSc, GenScript ProBio will provide plasmid and virus process development, GMP plasmid and virus clinical samples, and commercial manufacturing services.

As the first product in XLifeSc's pipeline, TAEST16001 enables autologous T-cell transduced with a replication incompetent lentiviral vector to express NY-ESO-1-specific TCR. According to a clinical study conducted by PI, reinfused T-cells have long-lasting effects on patients treated with TAEST16001. Phase 1 portion of an open, single arm and early clinical study of TAEST16001 in the treatment of solid tumor mainly containing soft tissue sarcoma with positive expression of tumor antigen NY-ESO-1 (HLA-A*02:01) is ongoing in Biotherapy Center/Melanoma and Sarcoma Medical Oncology Unit, Sun Yat-sen University Cancer Center.

GenScript ProBio congratulates XLifeSc on reaching an important milestone of TCR-T program.

"We congratulate XLifeSc on FDA allowance of its IND application for TCR-T program. TCR-T cell therapy has unprecedented potential for the treatment of solid tumor, which is a significant milestone for the immunotherapy field in China," said Dr. Brian Min, CEO of GenScript ProBio. "This is China's first TCR-T program targeting the treatment of solid tumor. XLifeSc has entrusted TCR-T products with independent intellectual property rights to GenScript ProBio as the first collaborative program. We are honored to provide technology and production support for such great program. We will follow up on the clinical studies. We wish this program proceed smoothly in US and benefit patients with solid tumor soon."

About Xiangxue Life Sciences

Xiangxue Life Sciences (XLifeSc) is a biopharmaceutical company focused on TCR-based therapies for cancer. XLifeSc's main proprietary technological platforms are composed of: (1) High Affinity T Cell Activation Core (HATac); (2) TCR Affinity Enhancing Specific T Cell Therapy (TAEST). The two platforms have been fully developed to the clinic-ready stage. As a result, an independently-owned intellectual property portfolio has been constructed which spans across the whole spectrum of TCR-related technologies including the identification of tumor-specific antigens, antigen-specific TCRs, and the optimization of antigen-specific TCRs in terms of affinity and stability, etc. To date, many domestic and PCT applications have been filed.

Housing several state-of-the-art laboratories, XLifeSc is capable of offering a broad range of R&D services, including (1) large scale GMP grade lentivirus production; (2) target identification and lead optimization; (3) efficacy validation and safety testing in cell lines and animal models; (4) clinical trial development; and (5) market entry planning. These capabilities and services can be either accessed as flexible stand-alone services on demand or as a part of integrated drug discovery programs. To meet the needs of different partners, we welcome all types of alliance opportunities such as out-license, co-development, and co-marketing.

About GenScript ProBio

GenScript ProBio is a world leading bio-pharmaceutical contract development and manufacturing organization (CDMO), with extensive services in gene synthesis, peptide synthesis, antibody development, protein expression and custom biological reagents, in addition to providing a one-stop biological drug R&D platform covering antibody drug discovery (hybridoma, phage display, full human and bispecific antibodies technologies), antibody engineering (antibody humanization, evaluation and optimization of drug compounds and affinity maturation), among others.

GenScript ProBio's total cell therapy solution covers IND preparation as well as clinical sample and commercial production. The scientific controls built into the production process ensures compliance, while testing and deviations are studied under strict research guidelines, improving the repeatability of tests and the traceability of data.

Toward the mission of "providing best-in-class quality and serving the interests of customers", GenScript ProBio is committed to helping customers shorten the timeline for biological drugs from development to clinical use, significantly lowering R&D costs, accelerating the commercialization of medicines, and building a healthy future while at the same time contributing to the development of the pharmaceutical industry under the Made in China 2025 plan.