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BE-101
- Development stage
- Discontinued
- Lead developer
- Be Biopharma
- Modality
- CRISPR-Cas9 → CRISPR Systems → Programmable Nucleases → Gene Editing → Gene Therapies, Other Engineered Cells → Adoptive Cell Transfer → Cell Therapies, Gene Silencing → Gene Therapies, Gene Addition/Replacement → Gene Therapies
- Administration
- Intravenous
01
Overview
**BE-101** is an investigational autologous engineered B-cell therapy developed by Be Biopharma for moderately severe to severe hemophilia B. The therapy uses ex vivo CRISPR/Cas9 editing to insert a human coagulation factor IX gene into a patient's own B cells. Following a single intravenous infusion, the edited cells are intended to engraft and continuously secrete functional factor IX into circulation, restoring clinically meaningful clotting-factor activity. BE-101 was evaluated in the Phase 1/2 BeCoMe-9 first-in-human study, which was terminated in June 2026 following a strategic business decision rather than a reported safety issue.
- Other names
- Factor IX B Cell Medicineengineered B cell medicine for Hemophilia B
02
Targets
F9 (Coagulation Factor IX)
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