Vergent Bioscience announced the completion of patient enrollment in its Phase 2 VISUALIZE trial, which is evaluating the efficacy and safety of abenacianine for injection (VGT-309) in patients with lung cancer. The trial aims to improve tumor visualization during minimally invasive and robotic-assisted surgical procedures using this novel imaging agent.
The VISUALIZE trial is a multi-center, open-label study that enrolled 89 patients with confirmed or suspected lung cancer across six sites in the United States and Australia. Each patient received a 0.32mg/kg dose of abenacianine for injection via a short infusion 12 to 36 hours before surgery. The primary efficacy endpoints include intraoperative tumor visualization, surgical margin assessment, and identification of additional cancers or positive lymph nodes not seen preoperatively.
Improving Tumor Visualization in Lung Cancer Surgery
Lung cancer surgery, involving the removal of tumor tissue, is a potentially curative treatment, especially when diagnosed early. Approximately 25% of lung cancer patients in the U.S. undergo surgery. Minimally invasive surgery (MIS) and robotic-assisted methods are increasingly used due to benefits like shorter hospital stays and reduced post-operative complications. However, these methods can compromise a surgeon's ability to visually distinguish tumors from normal tissue, making complete tumor removal challenging.
Abenacianine for injection is designed to address these limitations. It is a tumor-targeted fluorescent imaging agent that binds to cathepsins, a family of proteases overexpressed in various solid tumors. The imaging component, indocyanine green (ICG), is compatible with commercially available near-infrared (NIR) intraoperative imaging systems, minimizing background autofluorescence.
Mechanism of Action and Clinical Potential
Abenacianine for injection, invented at Stanford University School of Medicine, works by covalently binding to cathepsins, a family of proteases that are highly expressed in a wide range of solid tumors. This targeted approach aims to provide surgeons with enhanced visualization of tumors during surgery. Previous clinical studies suggest that abenacianine allows surgeons to visualize tumor tissue during MIS, potentially increasing their confidence during these procedures.
"The VISUALIZE trial will provide additional, valuable insights illuminating the potential of our novel imaging agent to address existing deficits in tumor visualization during lung surgery," said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience.
Next Steps
Vergent Bioscience intends to advance abenacianine for injection into a Phase 3 study following the data readout from the VISUALIZE trial. If the Phase 3 results are positive, the company plans to submit a new drug application (NDA) for abenacianine for injection for lung cancer.
