On September 24, 2020 XiangXue Life Sciences (XLifeSc), a partner of GenScript ProBio, reported FDA allowance of its IND application for TCR-T program (TCRT-ESO-A2). GenScript ProBio extends congratulations on this (Press release, GenScript, SEP 24, 2020, View Source [SID1234565590]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 an 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 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 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."