Core Insights - Theriva Biologics announced positive topline outcomes from the VIRAGE Phase 2b clinical trial for VCN-01 in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC) patients [1][3] Company Overview - Theriva Biologics is a diversified clinical-stage company focused on developing therapeutics for cancer and related diseases, with its lead product candidate being VCN-01, an oncolytic adenovirus [10][11] Clinical Trial Results - The VIRAGE trial involved 96 newly-diagnosed metastatic PDAC patients, showing that patients receiving 2 doses of VCN-01 plus chemotherapy had a median overall survival (OS) of 14.8 months compared to 11.6 months for those receiving chemotherapy alone [2] - In the primary endpoint analysis, patients treated with VCN-01 followed by chemotherapy had a median OS of 10.8 months, while those receiving only chemotherapy had a median OS of 8.6 months [5] - The trial demonstrated increased progression-free survival (PFS) and duration of response (DoR) in the VCN-01 treatment group, with median PFS of 7.0 months compared to 4.6 months for the control group [5] Safety Profile - VCN-01 was well-tolerated, with adverse events being transient and reversible, consistent with prior clinical trials [3][4] - The most common adverse events included pyrexia, flu-like illness, and elevated transaminases, which were less frequent after the second dose of VCN-01 [3] Future Directions - The positive data from the VIRAGE trial is expected to facilitate engagement with industry partners and support the design of a Phase 3 confirmatory trial [3][4]
Theriva™ Biologics Announces Primary Endpoints for Efficacy and Safety Achieved in VIRAGE Phase 2b Clinical Trial of VCN-01 with Gemcitabine/nab-Paclitaxel in Newly-Diagnosed Metastatic Pancreatic Cancer Patients