Pharma Focus Europe

Vergent Bioscience Launches Phase 2 VISUALIZE Study for VGT-309 in Lung Cancer Surgeries

Thursday, December 14, 2023

Vergent Bioscience, a biotechnology company in the clinical stage, is progressing with the enrollment of the initial cohort of patients for a Phase 2, multi-center study. This study focuses on evaluating the safety and effectiveness of VGT-309 in individuals diagnosed with lung cancer. The international VISUALIZE study is designed to explore the potential of Vergent's tumor-targeted fluorescent imaging agent in improving the visibility of hard-to-detect tumors during minimally invasive and robotic-assisted surgical procedures. The goal is to reduce the likelihood of leaving cancerous tissue behind. Six clinical trial sites in the United States and Australia are set to enroll 100 patients.

The rise of minimally invasive lung cancer surgeries, coupled with the increased detection of small tumors, poses challenges for surgeons in adequately visualizing all tumor tissue during procedures. Encouraging data from three Phase 1 and 2 clinical studies, including presentations at the World Conference on Lung Cancer in September 2023, indicate that VGT-309 is effective and safe for detecting lung tumor tissue.

John Santini, Ph.D., President, and CEO at Vergent Bioscience, expressed enthusiasm about advancing VGT-309 to the next phase of clinical development. The company collaborates with leading thoracic surgeons, academic institutions, and large community cancer centers to gather additional evidence regarding its potential utility in lung cancer surgery. Santini looks forward to sharing the results of the VISUALIZE study at the earliest opportunity.

The Phase 2 VISUALIZE study is an open-label, multi-center trial designed to assess the efficacy and safety of VGT-309 with near-infrared (NIR) imaging for identifying cancer in patients undergoing lung cancer surgery. Patients will receive VGT-309 through infusion a day before surgery. After attempting to identify tumors using standard surgical techniques, investigators will use a commercially available NIR endoscope with VGT-309 to assess the presence of tumor tissue, confirmed by pathology. The primary efficacy endpoints include intraoperative tumor visualization, surgical margin assessment, and identification of additional cancers or positive lymph nodes not seen preoperatively.

Dr. Sunil Singhal, the principal investigator for the study and William Maul Measey Professor in Surgical Research at the University of Pennsylvania Perelman School of Medicine, highlighted previous clinical data suggesting that VGT-309 highlights tumors not visible during minimally invasive surgeries. The study aims to further evaluate the agent's ability to facilitate complete tumor removal during surgery.

VGT-309 is a tumor-targeted imaging agent developed to provide optimal tumor visualization during various surgical procedures. Administered to patients through a short infusion before surgery, VGT-309, invented at Stanford University School of Medicine, tightly binds to cathepsins, a family of proteases overexpressed in various solid tumors. The imaging component of VGT-309 is the near-infrared (NIR) dye indocyanine green (ICG), compatible with commercially available NIR intraoperative imaging systems supporting minimally invasive surgery technologies and preferred for minimizing background autofluorescence.



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