Phase 2B study of tumor-targeted fluorescent imaging agent met primary efficacy endpoint, showing abenacianine helped surgeons see tumor tissue missed by standard surgical techniques
Vergent Bioscience, a clinical-stage biotechnology company developing tumor targeted imaging agents, announced new data being presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These results demonstrate that using intraoperative molecular imaging (IMI) with abenacianine for injection (VGT-309), the company’s investigational tumor-targeted fluorescent imaging agent, during lung surgery has the potential to help optimize tumor resection by enabling enhanced tumor removal and minimizing resection of normal tissue.
In the study, abenacianine localized tumors intraoperatively, identified synchronous and occult lesions, helped assess negative margin status, and identified cancer in the lymph nodes enabling a more complete oncologic resection (Abstract #3069). These results support findings from earlier clinical trials suggesting abenacianine helped surgeons see tumors in real time with minimally invasive and robotic-assisted surgical procedures.
“We are pleased to present these positive Phase 2B results from our VISUALIZE study, which demonstrated significantly improved surgical outcomes when abenacianine was added to standard surgical assessment techniques to identify tumor tissue in the lungs, further supporting the potential of this novel imaging agent to address current limitations in intraoperative tumor imaging,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We are committed to advancing minimally invasive and robotic-assisted surgery by enhancing tumor visualization in real time. We believe abenacianine has the potential to build surgeon confidence that all tumor tissue is removed during surgery and look forward to initiating our Phase 3 pivotal trial.”
The Phase 2B, multicenter, open-label VISUALIZE study enrolled 89 individuals undergoing surgery for suspected or known cancer in the lung at six clinical study sites in the United States and Australia. Each patient in the study received abenacianine preoperatively through intravenous infusion. Following an attempt to localize the patient’s target lung lesion using standard surgical techniques, investigators used a commercially available near infrared (NIR) endoscope with abenacianine to visualize the lesion, which was then assessed by pathology.
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 study, 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 to enable 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 in this study with no drug-related serious adverse events observed.
“The VISUALIZE study results demonstrate that standard surgical techniques fall short in the identification and removal of tumors in the lung,” said Sunil Singhal, M.D., lead investigator and chief of the division of thoracic surgery in the Perelman School of Medicine at University of Pennsylvania. “These results are clinically meaningful and support the potential benefit that tumor-targeted fluorescent imaging can have to improve minimally invasive surgical approaches in lung cancer.”
Dr. Singhal will share the results in the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology poster session on Monday, June 2, at 1:30 p.m. CT in Hall A.
About the VISUALIZE Clinical Trial
The Phase 2B, multicenter, open-label VISUALIZE study (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 study received 0.32mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor using standard surgical techniques, 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 (VGT-309)
Abenacianine for injection is a tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization with open, minimally invasive and robotic-assisted surgical procedures. Abenacianine for injection is delivered to patients via a short intravenous infusion several hours to several days 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, would provide distinct clinical advantages and position abenacianine for injection as an ideal tumor imaging agent. Abenacianine for injection’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, abenacianine for injection, 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 abenacianine 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.
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