MINNEAPOLIS--(BUSINESS WIRE)--Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that data published in The Annals of Thoracic Surgery reinforce the clinical potential of VGT-309, the company’s investigational intraoperative molecular imaging (IMI) agent, to help surgeons see difficult-to-find and previously undetected tumors in the lung during surgery. The findings support previous clinical trial results suggesting that VGT-309 could help ensure all tumor tissue is removed during minimally invasive and robotic-assisted surgical procedures.
“The expanded use of minimally invasive surgery, including robotic-assisted technologies, for lung cancer has created a significant and growing need for better visualization during these surgeries, which can be curative when lung cancer is diagnosed early enough and all tumor tissue is removed,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We are pleased that data from our clinical program continue to suggest VGT-309 may help overcome existing challenges to tumor visualization and thereby optimize surgical outcomes for physicians and patients.”
The Phase 2* efficacy study evaluated the frequency that IMI with VGT-309 improved surgical outcomes in 40 individuals with suspected or proven cancer in the lung who were eligible for surgery. The primary efficacy endpoint was the proportion of patients with at least one clinically significant event. Clinically significant events were defined as localization of lesions not found by standard surgical techniques, identification of synchronous and occult cancers, and identification of inadequate surgical margin.
Each patient in the study received VGT-309 preoperatively through intravenous infusion. Following an attempt to localize the target lesion using standard surgical techniques, investigators used a commercially available near infrared (NIR) endoscope to visualize the lesion, which was then assessed by pathology. Of the 40 participants administered VGT-309 who underwent the standard-of-care surgical resection for suspected lung cancer, 17 (42.5%) had at least one clinically significant event.
VGT-309 with NIR fluorescence imaging visualized a range of primary and metastatic tumor types intraoperatively, including adenocarcinoma in situ, invasive adenocarcinoma, lymphoma, colorectal cancer, neuroendocrine tumors, sarcomas, and squamous cell carcinoma. VGT-309 appeared safe and well tolerated in this study, with no infusion reactions and no drug-related serious adverse events.
“While the prevalence of minimally invasive surgery has increased over the years, these surgical approaches require surgeons to work in a small area with a restricted view and limited tactile clues, increasing the possibility that tumor tissue will be difficult to locate or even missed,” said study investigator and senior author Sunil Singhal, M.D., chief of the Division of Thoracic Surgery in the Perelman School of Medicine at University of Pennsylvania. “The study findings published today in The Annals of Thoracic Surgery add to the growing body of evidence suggesting that VGT-309 has the potential to provide meaningful benefit to both surgeons and cancer patients during minimally invasive surgery.”
To further evaluate the efficacy of VGT-309, Vergent is currently conducting the Phase 2 multicenter VISUALIZE study (NCT06145048). Investigators at six sites in the United States and Australia plan to enroll 100 patients in this Phase 2 study, which Vergent expects to complete by the end of 2024.
*This clinical trial (ClinicalTrials.gov Identifier: NCT05400226) was supported by the National Cancer Institute of the National Institutes of Health under award number R44CA277890. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About VGT-309
VGT-309 is a tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization during open, minimally invasive and robotic-assisted surgical procedures. VGT-309 is delivered to patients via a short intravenous infusion several hours before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are overexpressed across a broad range of solid tumors. This approach, if successful, provides distinct clinical advantages and positions VGT-309 as an ideal tumor imaging agent. VGT-309’s imaging component is the near infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is a preferred dye to minimize confounding background autofluorescence.
About Vergent Bioscience, Inc.
Vergent Bioscience is a clinical-stage biotechnology company that is helping surgeons realize the full potential of minimally invasive and robotic-assisted surgery by improving the visibility of tumors. Vergent’s lead compound, VGT-309, is a tumor-targeted fluorescent imaging agent designed to enable surgeons to see difficult-to-find or previously undetected tumors in real-time during surgery, so that they can ensure all tumor tissue is removed. The company is first evaluating VGT-309 for cancer in the lung, with the potential to expand its application to a wide range of solid tumors. Vergent Bioscience is a privately held company based in Minneapolis, MN.
