Vergent Bioscience has completed patient enrollment in its Phase 2 VISUALIZE trial, assessing the efficacy and safety of abenacianine for injection (VGT-309) in patients undergoing surgery for lung cancer. This multi-center trial, conducted across six sites in the United States and Australia, enrolled 89 patients. The investigational agent is designed to improve the visibility of tumors during minimally invasive and robotic-assisted surgical procedures.
Enhancing Tumor Visualization with Abenacianine
Abenacianine for injection is a novel, tumor-targeted fluorescent imaging agent. It is administered via a short intravenous infusion at a dose of 0.32mg/kg, 12 to 36 hours before surgery. The agent is designed to address the challenges surgeons face in distinguishing tumors from normal tissue during minimally invasive surgery (MIS) and robotic-assisted procedures, where sight and tactile feedback are often compromised.
VISUALIZE Trial Design and Endpoints
The Phase 2 VISUALIZE trial (NCT06145048) is an open-label study evaluating abenacianine for injection in patients with proven or suspected lung cancer. Following standard surgical techniques to identify tumors, investigators used a near-infrared (NIR) endoscope to assess the presence of tumor tissue, confirmed by pathology. Primary efficacy endpoints include intraoperative visualization of tumors, surgical margin assessment, and identification of additional cancers or positive lymph nodes not seen preoperatively.
Mechanism of Action and Potential Benefits
Abenacianine binds covalently to cathepsins, a family of proteases overexpressed in many solid tumors. The imaging component, indocyanine green (ICG), is compatible with commercially available NIR intraoperative imaging systems. Data from previous clinical studies suggest that abenacianine allows surgeons to visualize tumor tissue during MIS, potentially increasing their confidence during procedures. Approximately 25% of all U.S. lung cancer patients undergo lung cancer surgery, which can be curative if diagnosed early and all tumor tissue is removed.
Next Steps for Abenacianine
Vergent Bioscience intends to advance abenacianine into a Phase 3 study following data readout from the VISUALIZE trial. Assuming positive Phase 3 results, the company plans to file a new drug application (NDA) for abenacianine for injection for cancer in the lung.
