The Center for Drug Evaluation (CDE) website has indicated that GRIT Biotechnology, a China-based cell therapy specialist, has received approval for its in-house developed gene engineered tumor-infiltrating lymphocyte (TIL) therapy, GT201, for clinical studies in patients with recurrent or metastatic solid tumors.
Optimal Structural Design and Custom Retroviral System for TIL Engineering
GRIT Bio’s research and development team conducted comprehensive preclinical studies to compare and select the optimal structural design for their TIL therapy. They customized the retroviral system StaViral for engineering TIL therapy, which enables stable expression of target genes in TIL cells from multiple batches and various tumor sources. This advancement allows for a more reliable and consistent production process.
Enhanced Capabilities of GT201 Compared to Traditional TIL
GT201 has demonstrated superior proliferation ability, tumor killing capacity, cytokine release, and survival rates compared to traditional TIL therapies in both in vivo and in vitro settings. The therapy can also reduce dependence on IL-2, addressing challenges faced by traditional TIL products. By optimizing and enhancing the functionality and survival of traditional TIL products, GT201 has the potential to reduce the dosage of IL-2 required in clinical applications, offering a more effective and possibly less resource-intensive treatment option for patients.-Fineline Info & Tech
