Clinical TrialJun 11, 2026, 08:01 AM
Theriva Biologics VCN-01 Phase 1 HNSCC trial shows prolonged OS
AI Summary
Theriva Biologics announced the publication of clinical and translational results from VCN-01's Phase 1 clinical trial in Head & Neck Squamous Cell Carcinoma (HNSCC) in Clinical Cancer Research. The trial demonstrated prolonged overall survival in heavily pre-treated refractory HNSCC patients administered IV VCN-01 prior to durvalumab. Results support VCN-01's stroma-degrading and immune-enhancing modes-of-action, resensitizing tumors to durvalumab and reactivating immune responses.
Key Highlights
- Prolonged overall survival (OS) observed in heavily pre-treated HNSCC patients.
- VCN-01 resensitized refractory tumors to the immune checkpoint inhibitor durvalumab.
- Median OS was 17.3 months in Arm II HD and 15.5 months in Arm II LD.
- Pharmacokinetic, tissue biopsy, radiomic, and transcriptomic results support VCN-01's modes-of-action.
- Increased levels of PD-L1 positive T-cells and other biomarkers were found.
- Upregulation of CD8 and IDO observed in tumor biopsy samples.
- Upregulation of PD-1 and PD-L1 in tumors correlated with patient survival.
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