VIRAGE Study of VCN-01 Plus Chemotherapy for PDAC Initiates in the US

Activated T cells attack pancreatic cancer cells group © LASZLO -www.stock.adobe.com

Following reports that VCN-01 with gemcitabine/nab-paclitaxel as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) was safe and well-tolerated among patients treated in Spain, the phase 2b VIRAGE (NCT05673811) has now begun dosing patients in the United States.¹

With 4 sites open, patient dosing has been initiated in the United States. There are also 8 sites open in Spain, which were initiated in January 2023. The first patients now have received their second doses of VCN-01, which showed a safety profile consistent with what has been reported in prior studies. The trial remains on track to be fully-enrolled in the first quarter of 2024.

“Initiating dosing in the United States, 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 enrollment in the first quarter of 2024,” said Steven A. Shallcross, chief executive officer of Theriva Biologics, in a press release. “With a dearth of novel therapies available and a 5-year survival rate for metastatic PDAC of only 3%, pancreatic cancer is an indication that is ripe for innovation.”

VCN-01 is a systemic, selective, stroma-degrading oncolytic adenovirus that has been granted orphan drug designations from the FDA for the treatment of patients with pancreatic cancer.

The multinational, randomized, open-label, controlled, phase 2b clinical trial is assessing the combination of VCN-01 with standard-of-care chemotherapy in the first-line for patients with metastatic PDAC. Approximately 92 adult patients will be enrolled across the United States and Spain.

Enrollment is open to patients aged 18 years and older with histologically confirmed, newly-diagnosed metastatic PDAC.² Patients must have a minimum life expectancy of 5 months, an ECOG performance status of 0 or 1, adequate baseline hematologic, liver, renal and nutritional function within 1 week of randomization, and fertile men and female patients of childbearing potential must agree to use a reliable method of contraception.

In both the control and treatment arms, gemcitabine/nab-paclitaxel as the standard-of-care chemotherapy will be administered to patients over 28-day cycles. In the treatment arm only, patients will also be treated with systemically administered VCN-01 7 days before their first and fourth cycles of gemcitabine/nab-paclitaxel treatment.

Primary end points for the trial include overall survival, safety, and tolerability. Other end points being evaluated include progression-free survival, objective response rate, measures of biodistribution, VCN-01 replication, and immune response.

“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 favorable safety profile following the advancement to the second dose that further differentiates and positions VCN-01 as a leading oncolytic adenovirus. More broadly, this trial will enable us to determine the feasibility of repeated dosing of VCN-01, which could shift the paradigm for standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy, and thereby lead to improved clinical outcomes for patients with PDAC and other solid cancers,” added Shallcross, in a press release.¹

REFERENCES:

Theriva™ Biologics announces key progress in VIRAGE, an ongoing, multinational phase 2b trial of VCN-01 in combination with chemotherapy in pancreatic ductal adenocarcinoma. News release. Theriva Biologics. August 2, 2023. Accessed August 8, 2023. https://tinyurl.com/4bhhffhs

Study of nab-paclitaxel and gemcitabine and plus/minus VCN-01 in patients with metastatic pancreatic cancer (VIRAGE). ClinicalTrials.gov. Updated June 27, 2023. Accessed August 8, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05673811