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LG631
- Development stage
- Phase 2
- Lead developer
- Lentigen Technology
- Modality
- Gene Therapies, Stem Cell Therapies → Cell Therapies
- Administration
- Intravenous
01
Overview
**LG631** is a lentiviral vector-based gene therapy designed to deliver a mutated human O6-methylguanine-DNA methyltransferase (MGMT P140K) gene to autologous hematopoietic stem cells (HSCs), rendering them resistant to temozolomide (Temodar) chemotherapy. Developed by Lentigen Corporation (now Opus Bio), it aims to protect bone marrow stem cells from dose-limiting toxicity, enabling higher chemotherapy doses for glioblastoma multiforme (GBM) treatment post-surgery. The therapy involves ex vivo transduction of patient HSCs followed by reinfusion; it received FDA orphan drug designation in 2013 and entered a Phase I trial in collaboration with UH Case Medical Center and Case Western Reserve University.
- Other names
- P140K methylguanine methyltransferase (MGMT) transduced hematopoietic stem cells
02
Targets
O6-MeG (O6-methylguanine DNA lesion)
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