TCRCure Receives IND for Phase I/II TC-E202 Cervical Cancer Clinical Trial from NMPA
19 November 2021. TCRCure have received Investigational New Drug (IND) approval from the CENTER FOR DRUG EVALUATION, NMPA (the “CDE”)for the Phase 1/2 clinical study of Modified autologous T cells for targeting HPV and delivery of anti-PD-1 in the treatment of HPV-positive recurrence and metastasis cervical cancer.
GMP certified Guangdong manufacturing site construction launched
TCRCure’s Guangdong manufacturing site, which includes GMP certified cell production facilities, office space, and labs for quality assurance, research and development, launched construction in Guangdong Medical Valley.
In May 2019, TCRCure opened a new research and manufacturing site in the Los Angeles bioscience corridor. The 5000 square foot facility includes 1400 s.f. of GMP-compliant manufacturing space and 1000 s.f. of R&D space, plus additional flex space. Patient cell therapy products will be produced in a 600 square foot ISO 7 cleanroom according to cGMPs for cell-therapy manufacturing. It will be TCRCure’s major site for clinical-grade therapeutic production in the US.