VIRAGE Phase 2b trial meets primary OS endpoint; VCN-01+SoC mOS 10.8 vs 8.6 months

Theriva Biologics, Inc.

VCN-01 + gem/nab-paclitaxel met primary OS endpoint in FAS: median 10.8 vs 8.6 months, HR 0.57 (p=0.034).
PFS improved: 7.0 vs 4.6 months (HR 0.55, p=0.012) and duration of response doubled (11.2 vs 5.4 months).
Patients receiving 2 VCN-01 doses had greater OS benefit: median 14.8 vs 11.6 months (HR 0.44).
VCN-01 was safe and well tolerated; related SAEs were transient and resolved.
Data support further evaluation in larger blinded trial with additional VCN-01 doses.

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