Following clearance by the FDA and AEMPS, the phase 2b VIRAGE trial of VCN-01 plus gemcitabine and nab-paclitaxel dosed its first patient with pancreatic ductal adenocarcinoma.
Trial Name: A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer
ClinicalTrials.gov Identifier: NCT05673811
Sponsor: Theriva Biologics SL
Recruitment Contact: Manuel Cascallo, PhD, +34935712359, MCascallo@vcnbiosciences.com, and Michael Kaleko, MD, PhD, 1-3014174364, mkaleko@therivabio.com
Completion Date: April 28, 2025
The first patient has been dosed in the phase 2b VIRAGE trial (NCT05673811) of systemically administered VCN-01 plus standard of care (SOC) chemotherapy in the first-line for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), according to Theriva Biologics.1
VCN-01 is a genetically modified adenovirus. The agent is made up of the presence of 4 independent genetic modifications on the backbone of the wild-type human adenovirus serotype 5 (HAd5) genome. VCN-01 can selectively and aggressively replicate within tumor cells, and degrade the tumor stroma barrier which serves as a barrier to cancer treatment.2
This phase 2b clinical trial follows clearance from the FDA and Spanish Agency for Medicines and Health Products (AEMPS). While this first patient was dosed in Spain, the trial is anticipated to enroll 92 adults at up to 25 sites across the United States and Germany as well.
“The dosing of the first patient in our phase 2b PDAC trial represents an important step in our pursuit to address unmet needs for patients with difficult-to-treat cancers,” said Steven A. Shallcross, chief executive officer of Theriva Biologics, in the press release. “The incidence of PDAC continues to rise and while it continues to have one of the lowest survival rates among all cancer types, efforts to improve upon the standard of care treatment have largely stalled. In contrast, we are encouraged by the growing clinical data that underscore VCN-01’s differentiated mechanism of action, as well as the biological activity and synergistic clinical benefit observed in combination with SoC chemotherapy for patients with PDAC and other solid tumors. With regulatory clearance from the FDA and AEMPS, we look forward to the continued progress of this program and more broadly, the advancement of our novel OV platform.”
In the randomized, open-label, placebo-controlled, multicenter, 2-arm, phase 2 trial, VCN-01 will be administered to patients in combination with SOC chemotherapy consisting of gemcitabine and nab-paclitaxel over 28-day cycles.2
Within the treatment arm only, patients will also be systemically administered VCN-01 7 days before their first and fourth cycle of SOC chemotherapy treatment.
Patients aged 18 years or over are eligible for enrollment if they have histologically or cytologically confirmed, first-line metastatic PDAC stage IV de novo. Patients must have never received previous systemic treatment for their cancer, have at least 1 measurable tumor lesion, a minimum life expectancy of 5 months, an ECOG performance status of 0 or 1, and adequate baseline organ function, including hematologic, liver, renal, and nutritional, within 1 week of randomization. Male patients and female patients of childbearing potential also must agree to use effective contraception during the duration of the study.
The primary end points of the trial are overall survival and the safety and tolerability of VCN-01 as measured by the incidence of . Secondary end points include progression free survival, objective response rate, disease control rate, 1-year survival, duration of response, and changes in tumor marker Ca 19.9.
As an open-label trial, investigators will monitor the progress closely in order to potentially accelerate the clinical program to the next step, if supported by emerging data.
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