Clinical TrialJun 11, 2026, 10:20 AM
Theriva Biologics VCN-01 Phase I HNSCC trial results published
AI Summary
Theriva Biologics announced the publication of clinical and translational results from its Phase I clinical trial of VCN-01 in head and neck squamous cell carcinoma (HNSCC) in Clinical Cancer Research. The study demonstrated prolonged overall survival in heavily pre-treated HNSCC patients receiving VCN-01 intravenously before durvalumab. Pharmacokinetic, biopsy, radiomic, and transcriptomic data supported VCN-01's proposed mechanisms of stromal degradation and immune potentiation, suggesting resensitization of refractory tumors to durvalumab.
Key Highlights
- VCN-01 Phase I trial results in HNSCC published in Clinical Cancer Research.
- Prolonged overall survival (OS) observed in HNSCC patients treated with VCN-01 and durvalumab.
- Mechanistic data supports VCN-01's stromal degradation and immune potentiation.
- Increased PD-L1 positive T-cells and other biomarkers observed after VCN-01 and durvalumab.
- Median OS was 10.3 months (Group I LD), 15.5 months (Group II LD), and 17.3 months (Group II HD).
- Median progression-free survival (PFS) ranged from 1.6 to 3.7 months across groups.
- Circulating hyaluronidase PH20 levels increased significantly after VCN-01 administration.
- Tumor biopsies showed upregulation of CD8, IDO, PD-1, and PD-L1, with reduced FoxP3, CD25, CTLA4.
Price Impact
More from TOVX