Theriva’s VCN-01 Boosts Survival In Phase 2b Pancreatic Cancer Trial, Supporting First-Line Use

Theriva™ Biologics has announced positive topline results from its Phase 2b VIRAGE trial evaluating VCN-01 in combination with standard chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC). VCN-01, an oncolytic adenovirus engineered to selectively target tumors and degrade tumor stroma, showed clinically meaningful improvement in survival metrics when combined with gemcitabine and nab-paclitaxel. The therapy has already received Orphan Drug and Fast Track designations from the FDA for pancreatic cancer.

Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, commented, “The exciting topline data from the VIRAGE Phase 2b trial demonstrate the potential opportunity for VCN-01 to benefit metastatic PDAC patients treated with gemcitabine/nab-paclitaxel SoC chemotherapy. The significantly reduced hazard ratios for survival parameters in the VCN-01 treatment group provide compelling evidence that VCN-01 in combination with gemcitabine/nab-paclitaxel may extend the lives of metastatic PDAC patients. These data, combined with recent advice from the U.S. FDA and the European Medical Agency, are expected to facilitate engagement with industry partners and enable the design of a Phase 3 confirmatory trial that, if successful, may deliver an important new therapeutic option for patients suffering this rapidly fatal disease.”

In the 96-patient trial, those receiving VCN-01 plus chemotherapy showed a median overall survival (OS) of 10.8 months compared to 8.6 months with chemotherapy alone. Median progression-free survival (PFS) was also notably higher in the VCN-01 group (7.0 vs 4.6 months), as was the median duration of response (11.2 vs 5.4 months). Patients who received two doses of VCN-01 along with four or more cycles of chemotherapy had the highest median OS at 14.8 months. These findings suggest a potential dose-response benefit and confirm VCN-01’s clinical value when used in combination therapy.

VC-01, under investigation, was well tolerated with a Safety profile in terms of side effects that are normal, tolerable and far less severe in the second dose. An Independent Data Monitoring Committee found the adverse events to be in line with expectations for the treatment setting and patient population. Theriva will invite specialists in pancreatic cancer from Weill Cornell and Johns Hopkins to host an online session in order to elaborate on the data.