Theriva Biologics has announced the dosing of the first patient in the Phase IIb VIRAGE clinical trial of systemically administered VCN-01, along with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel), for pancreatic ductal adenocarcinoma (PDAC).
In the randomised, open-label, placebo-controlled, multicentre trial, VCN-01 in combination with SoC chemotherapy will be given as a first line therapy for metastatic PDAC patients.
Initiation of this trial comes after the company received clearance from the US Food and Drug Administration (FDA) and the Spanish Agency for Medicines and Health Products (AEMPS).
The two-arm Phase IIb trial will include subjects with histologically confirmed, newly-diagnosed metastatic PDAC.
At up to 25 sites in the US, Spain, and Germany, the VIRAGE trial is expected to enrol a maximum of 92 adult participants.
Patients in the control and treatment arms will receive gemcitabine/nab-paclitaxel SoC chemotherapy for 28-day cycles.
In the treatment arm only, they will also be given systemically administered VCN-01 seven days before the first and fourth gemcitabine/nab-paclitaxel treatment cycles.
Overall survival and VCN-01 safety/tolerability are the trial’s primary endpoints.
Objective response rate, progression free survival, biodistribution measures, VCN-01 replication, and immune response are included as additional endpoints.
Progress of the patients will be monitored closely as it is an open label trial, and measures may be implemented to expedite the clinical programme, if supported by the emerging data.
Theriva Biologics CEO Steven Shallcross said: “The dosing of the first patient in our Phase IIb PDAC trial represents an important step in our pursuit to address unmet needs for patients with difficult-to-treat cancers.
“With regulatory clearance from the FDA and AEMPS, we look forward to the continued progress of this programme and more broadly, the advancement of our novel OV platform.”