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daznelimgene lisbac
- Development stage
- Phase 2
- Lead developer
- OS Therapies
- Administration
- Intravenous
01
Overview
**Daznelimgene lisbac** (OST-HER2) is a HER2-targeted cancer immunotherapy developed by OS Therapies using a bioengineered form of **Listeria monocytogenes** bacteria to stimulate a potent immune response against HER2-expressing cancer cells, including primary tumors, metastases, and micrometastases. It activates CD8 T-cells, CD4 T-cells, NK cells, and dendritic cells. The drug has shown statistically significant improvements in 12-month event-free survival (33-35% vs. 20% historical control, p=0.0158) and 2-year overall survival (75% vs. 40%, p<0.0001) in a Phase 2b trial for preventing or delaying recurrence in fully resected pulmonary metastatic osteosarcoma, with a favorable safety profile. It has received FDA Rare Pediatric Disease, Fast Track, and Orphan Drug designations, plus EMA Orphan Drug designation, and OS Therapies plans a BLA submission for accelerated approval in early 2026.[1][2][3][4][6][8]
- Brand names
- OST-HER2OST-HER-2OST-HER 2
- Other names
- Lovaxin B
02
Targets
ERBB2 (Erb-b2 receptor tyrosine kinase 2)
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