Vergent Bioscience Initiates Phase 2, Multi-Center VISUALIZE Study Evaluating Efficacy of Tumor-targeted Fluorescent Imaging Agent VGT-309 in Lung Cancer Surgeries

Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that the company has enrolled the first patients in a Phase 2, multi-center study evaluating the efficacy and safety of VGT-309 in patients with cancer in the lung. The international VISUALIZE study will assess the potential of Vergent’s tumor-targeted fluorescent imaging agent to improve the visibility of difficult-to-find and previously undetected tumors during minimally invasive and robotic-assisted surgical procedures, and reduce the possibility that cancer is left behind. Investigators at six clinical trial sites in the United States and Australia plan to enroll 100 patients.

The widespread adoption of minimally invasive lung cancer surgery, coupled with increasing detection of small tumors, have made it more challenging for surgeons to see all tumor tissue during surgery. Data from three Phase 1 and 2 clinical studies, including findings presented in September 2023 at the World Conference on Lung Cancer (WCLC), have yielded favorable data that suggest VGT-309 is active and can safely be used to detect tumor tissue in the lung.

“We are thrilled to advance VGT-309 to this next stage of clinical development, working with leading thoracic surgeons, academic institutions and large community cancer centers to gather additional evidence regarding its potential utility in lung cancer surgery,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We look forward to sharing the VISUALIZE results as soon as they are available.”

The Phase 2, multi-center, open-label VISUALIZE study is designed to evaluate the efficacy and safety of VGT-309 with near-infrared (NIR) imaging to identify cancer in patients undergoing surgery for proven or suspected cancer in the lung. Each patient in the study will receive VGT-309 as an infusion the day prior to surgery. Following an attempt to identify each tumor using standard surgical techniques, investigators will use a commercially available NIR endoscope with VGT-309 to assess the presence of tumor tissue, which will then be confirmed by pathology. Primary efficacy endpoints include visualization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively.

“Clinical data to date suggest that VGT-309 highlights tumors that would otherwise not be visible during minimally invasive surgeries,” said Sunil Singhal, M.D., William Maul Measey Professor in Surgical Research at University of Pennsylvania Perelman School of Medicine, and principal investigator for the study. “We look forward to expanding on our previous studies to further evaluate this agent and its ability to facilitate the complete removal of tumor during surgery.