Theriva Biologics reveals positive VCN-01 study results

The candidate is a stroma-degrading oncolytic adenovirus for the treatment of pancreatic cancer

Theriva Biologics, a company focused on developing cancer treatments in areas of high unmet need, has announced significant progress in its VIRAGE clinical trial.

The study is a multi-location, phase 2b, randomised, open-label clinical trial researching VCN-01 when combined with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy among patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

VCN-01 is Theriva’s systemic stroma-degrading oncolytic adenovirus and has been awarded orphan drug designations from the US Food and Drug Administration and the European Medicines Agency for treating pancreatic cancer.

Patient dosing has commenced at four sites in the US, along with a further eight sites in Spain. The study remains on track to complete enrolment by next year. Meanwhile, patients dosed in Spain earlier this year have now received their second doses of intravenous VCN-01. These were well tolerated and delivered a safety profile consistent with prior studies.

Steven Shallcross, chief executive officer of Theriva Biologics, was encouraged by the latest details emerging from the VCN-01 trial: “Initiating dosing in the US, and the completion of the second VCN-01 doses for the first patients in Spain, are important accomplishments that add to the strong momentum for VIRAGE, which remains on track to complete enrolment in the first quarter of 2024.”

He added: “With a dearth of novel therapies available and a five-year survival rate for metastatic PDAC of only 3%, pancreatic cancer is an indication that is ripe for innovation. Through VIRAGE’s advancement, we aim to demonstrate VCN-01’s ability to address the unmet needs of pancreatic cancer patients by synergistically combining with standard-of-care chemotherapy.

“We are extremely encouraged by the favourable safety profile following the advancement to the second dose that further differentiates and positions VCN-01 as a leading oncolytic adenovirus.”