Key data and conclusions featured in the Poster Presentation include:
|
· |
Safety: Treatment with VCN-01 had an acceptable safety profile when administered with durvalumab in the sequential regimen (single dose of VCN-01 administered 14 days prior to the first dose of durvalumab; n=14). |
|
o |
The most common treatment-related adverse events (TRAEs) were pyrexia, flu-like symptoms and increases in liver transaminases. |
|
o |
TRAEs were dose-dependent, reversible and consistent with TRAEs previously described for other adenovirus-based products. |
|
· |
Pharmacokinetics (PK) and pharmacodynamics (PD): Based on toxicology and PK/PD analysis the recommended Phase 2 dose is 1x1013 viral particles (vp)/patient. |
|
· |
Biological activity: Sustained blood levels of VCN-01 viral genomes and increased serum hyaluronidase levels were maintained for over six weeks. |
|
o |
Observed an increase in CD8 T cells, a marker of tumor inflammation and an upregulation of PD-L1 in tumors. |
|
o |
Analysis of serial tumor biopsies revealed differential gene expression profiles and downregulation of matrix-related pathways after VCN-01 administration. |