VCN-01 Plus Chemo Wins FDA Fast Track Designation in Pancreatic Cancer

• The FDA has granted a fast track designation to VCN-01 given in combination with chemotherapy for the treatment of patients with metastatic pancreatic adenocarcinoma.
• VCN-01 is being evaluated in an ongoing phase 2b trial (VIRAGE; NCT05673811) for its effectiveness in treating pancreatic ductal adenocarcinoma (PDAC) as a first-line therapy.
• VCN-01 shows promise due to its ability to directly target tumors and degrade tumor stroma, a barrier to treatment in PDAC.

VCN-01 given in combination with gemcitabine and nab-paclitaxel has received a fast track designation from the FDA for treating patients with metastatic pancreatic adenocarcinoma.¹

The VIRAGE trial, an ongoing, multinational phase 2b study, is currently evaluating the combination of VCN-01 given via intravenous (IV) infusion plus standard-of-care chemotherapy as a first-line treatment for patients with PDAC.

“The FDA’s decision to grant fast track designation to VCN-01 highlights the urgent need for new treatment options for PDAC, which accounts for the fourth highest cause of cancer-associated deaths in the United States and Europe,” said Steven A. Shallcross, chief executive officer of Theriva Biologics, in the press release. “VIRAGE, our phase 2b trial evaluating VCN-01 in metastatic PDAC continues to progress, with enrollment expected to complete in the third quarter of 2024.”

Pancreatic cancer anatomy concept: © Лилия Захарчук - stock.adobe.com

VCN-01 is a genetically modified adenovirus being developed for the treatment of pancreatic cancer. In preclinical studies, treatment with the oncolytic adenovirus demonstrated direct antitumor efficacy and degraded the tumor stroma in PDAC.²

In June 2023, the FDA granted an orphan drug designation to VCN-01 for the treatment of patients with PDAC.²

Over 80 patients in various clinical trials have been treated with VCN-01, including in the VIRAGE study in patients with PDAC.1 Patients with head and neck squamous cell carcinoma have been treated with the agent in combination with an immune checkpoint inhibitor, patients with ovarian cancer have been given VCN-01 with chimeric antigen receptor (CAR)-T cell therapy, and the adenovirus has also been given to patients with colorectal cancer and retinoblastoma via intravitreal injection.

“Fast track designation is an important step that furthers our ability to expedite the review of and build upon the compelling clinical data that underscores VCN-01’s multiple modes of action and therapeutic potential in combination with chemotherapy or immunotherapy. We will continue to deliver on our mission to advance new therapeutic options for these patients,” added Shallcross in the press release.

About the Phase 2b VIRAGE Study

The phase 2b VIRAGE trial follows an open-label, randomized, 2 parallel arm design. Investigators are assessing SOC treatment with or without VCN-01 in patients with pancreatic cancer.

Enrollment is open to patients with histologically or cytologically confirmed, treatment-naive, metastatic PDAC. Patients must have at least 1 measurable lesion, a minimum life expectancy of 5 months, an ECOG performance status of 0 or 1, and adequate baseline organ function.³

On days 1, 8, and 15 of each 28-day cycle, nab-paclitaxel will be administered, followed by gemcitabine after the completion of nab-paclitaxel. VCN-01 will be given as a single IV infusion on day 1 of the first cycle and on day 1 of the fourth cycle, 7 days prior to the first and fourth cycles of chemotherapy.^2,3

The coprimary end points being evaluated in VIRAGE consist of overall survival and the incidence of patients with adverse events. The secondary end points include time to progression, overall response rate, disease control rate, 1-year survival, progression-free survival, duration of response, and changes in tumor marker Ca 19.9.

REFERENCES:

1. Theriva Biologics announces fast track designation granted by the U.S. FDA for VCN-01 for the treatment of metastatic pancreatic cancer. News release. Theriva Biologics. May 23, 2024. Accessed May 23, 2024. https://tinyurl.com/3tetxdy2

2. Theriva Biologics announces orphan drug designation granted by the U.S. FDA for VCN-01 for the treatment of pancreatic cancer. News release. Theriva Biologics. June 27, 2023. Accessed May 23, 2024. https://tinyurl.com/yyy4jkc2

3. Study of nab-paclitaxel and gemcitabine and plus/minus VCN-01 in patients with metastatic pancreatic cancer (VIRAGE). ClinicalTrials.gov. Updated April 19, 2024. Accessed May 23, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT05673811