UBriGene Supports FDA IND Clearance for GT307 TIL Therapy
Tuesday, March 17, 2026
uBriGene Biosciences, a global CDMO, has supported its strategic partner Grit Biotechnologies in securing clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for GT307. The therapy is a next-generation gene-edited tumour-infiltrating lymphocyte (TIL) treatment.
uBriGene contributed to the programme by providing technology transfer, process development, GMP manufacturing, and regulatory support. These efforts helped move GT307 from early development to clinical readiness.
The company used its TIL-Turbo production platform, a closed and automated system designed to reduce variability and contamination risks while ensuring consistent cell expansion. Through this platform, uBriGene completed process transfer, verification, and GMP manufacturing at its Maryland plant, producing material suitable for initial human studies.
GT307 uses CRISPR/AaCas12MAX gene-editing technology to remove key immune regulatory genes. This approach aims to overcome limitations of traditional TIL therapies, including reduced effectiveness within the tumour environment and limited persistence in the body.
The production platform has completed more than ten GMP manufacturing runs and can deliver high-yield cell expansion within around three weeks, consistently meeting clinical-grade requirements.
Source: ubrigene.com
