VGT-309

Phase 2B clinical trial of tumor-targeted fluorescent imaging agent met primary efficacy endpoint, showing abenacianine helped surgeons see tumor tissue missed by standard surgical techniques MINNEAPOLIS--(BUSINESS WIRE)-- Vergent Bioscience , a clinical-stage biotechnology company developing a tumor-targeted imaging platform, announced that data published in The Annals of Surgical Oncology (ASO) demonstrated clinical utility of abenacianine, the company’s investigational intraoperative molecular imaging (IMI) agent. The results showed the intraoperative molecular imaging agent’s ability to visualize tumors during lung cancer surgery, and the potential to optimize resection by localizing primary and metastatic tumors and minimizing removal of normal tissue. These data support findings from earlier clinical trials suggesting abenacianine helped surgeons see tumors in real time during minimally invasive and robotic-assisted surgical procedures. “As lung cancer surgery continues to advance, the need for technologies that help surgeons see cancer in real time to inform their intraoperative decision-making is critical,” said Adam Gridley, president and chief executive officer at Vergent Bioscience. “We believe abenacianine has the potential to fundamentally improve how surgeons approach tumor visualization in the lung, facilitating complete and confident resections, with the opportunity to extend this approach across a broad range of solid tumors. We are excited to progress our ongoing Phase 3 trial to further evaluate the potential of abenacianine for cancer in the lung including additional infusion timing flexibility out to four days before surgery.” The Phase 2B, multicenter, open-label VISUALIZE trial enrolled 89 individuals undergoing surgery for suspected or known cancer in the lung at six clinical investigative sites in the United States and Australia. Each patient in the trial received abenacianine preoperatively by intravenous infusion. Following an attempt to localize the patient’s target lung lesion using standard surgical techniques, investigators used commercially available surgical near infrared (NIR) imaging systems with abenacianine to visualize the lesion, which was then assessed by pathology. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The primary efficacy endpoint was the proportion of patients with at least one clinically significant event (CSE) defined as localization of lesions not found by standard surgical techniques, identification of additional cancers, identification of inadequate surgical margins confirmed by pathology, and detection of cancerous lymph nodes. Of the 89 patients included in the trial, 40 (45%) of the patients had at least one CSE; meaning that, in 45 percent of surgical cases, the addition of abenacianine provided actionable information to surgeons resulting in improved surgical outcomes. Tumors visualized by IMI with abenacianine included primary lung cancers (adenocarcinoma, squamous cell carcinoma, neuroendocrine tumor) and cancers that metastasized to the lung (breast, colorectal, prostate, thymoma, renal cell, sarcoma). Abenacianine appeared safe and well tolerated with no drug-related serious adverse events observed. “While surgery remains the foundation of treatment of lung cancer, surgeons continue to face challenges in identifying small lesions and ensuring complete tumor removal,” said clinical trial investigator and senior author Sunil Singhal, M.D., chief of the Division of Thoracic Surgery in the Perelman School of Medicine at the University of Pennsylvania. “These results further strengthen the growing body of evidence supporting intraoperative molecular imaging with abenacianine as a means to enhance tumor visualization during surgery, enabling more precise resection and helping to reduce the risk of leaving cancer behind.” To further evaluate the efficacy of abenacianine, Vergent is currently conducting the Phase 3 multicenter VISUALIZE-2 clinical trial ( NCT07499674 ). Enrollment in this trial is advancing rapidly with a New Drug Application (NDA) submission to the Food and Drug Administration (FDA) planned in 2027. About the VISUALIZE Clinical Trial The Phase 2B, multicenter, open-label VISUALIZE trial ( NCT06145048 ) was designed to evaluate the efficacy and safety of abenacianine for injection in patients undergoing surgery for proven or suspected cancer in the lung. Each of the 89 patients in the trial received 0.32 mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor using standard surgical techniques alone, investigators used a commercially available near-infrared (NIR) endoscope to assess the presence of tumor tissue, which was then confirmed by pathology. The primary efficacy endpoint included localization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively. About Abenacianine for Injection Invented in Dr. Matt Bogyo’s lab at Stanford University School of Medicine, abenacianine is a tumor-activated intraoperative imaging platform designed to deliver molecular insight during surgery by revealing malignant tissue undetectable under white light. Administered via a short intravenous infusion several hours to several days before surgery, abenacianine binds covalently to cathepsins, a family of proteases overexpressed across a broad range of solid tumors. The agent incorporates the near-infrared (NIR) dye indocyanine green (ICG), which is compatible with commercially available NIR imaging systems widely used in minimally invasive and robotic surgery. This compatibility and dosing flexibility enable seamless integration into existing surgical workflows. About Vergent Bioscience, Inc. Vergent Bioscience is a clinical-stage biotechnology company advancing molecularly targeted imaging technologies designed to support surgeons and unlock the full potential of minimally invasive and robotic cancer surgery. Vergent’s lead compound, abenacianine for injection, is a tumor-activated intraoperative imaging agent designed to reveal malignant tissue undetectable under white light – guiding surgical decision-making and enabling complete resections. The company is initially focused on lung cancer, with plans to expand the technology across multiple solid tumor types, including colorectal, breast, prostate, and ovarian cancers. Vergent Bioscience is a privately held company based in Minneapolis, MN. Contacts Media Contact Laura Morgan Sam Brown, Inc. 1-951-333-9110 lauramorgan@sambrown.com