Vergent Bioscience Reports Promising Phase 2B Results for Abenacianine, Advancing Real-Time Tumor Imaging During Lung Cancer Surgery
Vergent Bioscience, a clinical-stage biotechnology company focused on developing innovative tumor-targeted imaging technologies, has announced the publication of encouraging clinical data supporting its investigational intraoperative molecular imaging (IMI) agent, abenacianine, in The Annals of Surgical Oncology. The newly published findings demonstrate the agent’s ability to help surgeons visualize tumors in real time during lung cancer surgery, potentially improving surgical precision and reducing the likelihood of leaving cancerous tissue behind.
The results add to a growing body of evidence supporting the use of molecular imaging during cancer surgery and highlight the potential of abenacianine to transform how surgeons identify and remove tumors. According to the study, the imaging agent provided clinically meaningful information in nearly half of the procedures evaluated, enabling surgeons to detect lesions that conventional surgical techniques alone could not identify.
Vergent believes these findings reinforce the therapeutic potential of abenacianine not only in lung cancer surgery but also across a broad range of solid tumors where accurate tumor visualization remains a significant clinical challenge.
Improving Surgical Precision Through Molecular Imaging
Successful cancer surgery depends on the complete removal of malignant tissue while preserving as much healthy tissue as possible. However, identifying tumors during surgery can be difficult, particularly when lesions are small, deeply located, or not readily visible using conventional imaging techniques.
Current surgical approaches rely primarily on preoperative imaging, anatomical landmarks, palpation, and visual inspection. Although these methods are effective in many cases, they may fail to identify hidden tumors, microscopic disease, or involved lymph nodes. Missing even a small amount of cancerous tissue can increase the risk of recurrence and may require additional treatment or repeat surgery.
Vergent’s investigational imaging platform is designed to address these limitations by providing surgeons with real-time visualization of tumors during the procedure itself.
Abenacianine is administered intravenously before surgery and works with commercially available near-infrared (NIR) imaging systems to illuminate cancerous tissue during the operation. This enhanced visualization enables surgeons to identify tumors more accurately, assess surgical margins, and potentially detect additional malignant lesions that would otherwise remain unnoticed.
Published Results Demonstrate Clinical Utility
The newly published data originate from the company’s Phase 2B VISUALIZE clinical trial, a multicenter, open-label study evaluating the performance of abenacianine in patients undergoing surgery for suspected or confirmed lung cancer.
The trial enrolled 89 patients across six leading clinical centers in the United States and Australia. Each participant received a preoperative intravenous infusion of abenacianine before surgery.
During each operation, surgeons first attempted to locate the patient’s target lung lesion using conventional surgical techniques. After completing this standard assessment, investigators activated commercially available near-infrared imaging systems to visualize the tumor using the fluorescence generated by abenacianine.
Following surgical removal, all identified lesions underwent pathological examination to confirm the findings.
This study design allowed investigators to directly compare the information provided by standard surgical methods with the additional information generated through intraoperative molecular imaging.
Primary Endpoint Focused on Clinically Significant Events
The primary objective of the VISUALIZE study was to determine how frequently abenacianine provided surgeons with clinically meaningful information that altered intraoperative decision-making.
Researchers defined a clinically significant event (CSE) as one or more of the following:
- Localization of tumors not identified using standard surgical techniques
- Detection of previously unrecognized malignant lesions
- Identification of inadequate surgical margins later confirmed by pathology
- Detection of cancerous lymph nodes
These events represent situations where enhanced visualization could directly influence surgical management and potentially improve patient outcomes.
Nearly Half of Patients Experienced Clinically Meaningful Benefit
Among the 89 patients included in the study, 40 patients (45%) experienced at least one clinically significant event during surgery.
In practical terms, this means that nearly one out of every two surgical procedures benefited from additional information provided by abenacianine that was not available through conventional surgical assessment alone.
The findings suggest that intraoperative molecular imaging has the potential to substantially improve surgeons’ ability to identify cancerous tissue while patients remain in the operating room.
Such information may help physicians make immediate adjustments to the surgical procedure, potentially avoiding incomplete resections or unnecessary removal of healthy tissue.
Broad Detection Across Multiple Tumor Types
An important aspect of the study was the diversity of cancers successfully visualized using abenacianine.
The imaging agent enabled visualization of several forms of primary lung cancer, including:
- Adenocarcinoma
- Squamous cell carcinoma
- Neuroendocrine tumors
In addition, abenacianine successfully highlighted tumors that had metastasized to the lungs from several other primary cancers, including:
- Breast cancer
- Colorectal cancer
- Prostate cancer
- Thymoma
- Renal cell carcinoma
- Sarcoma
These results suggest that the imaging platform may have applications extending well beyond primary lung malignancies.
The ability to visualize metastatic lesions from multiple tumor types could significantly broaden the future clinical utility of the technology.
Supporting Minimally Invasive and Robotic Surgery
Modern thoracic surgery increasingly relies on minimally invasive approaches, including video-assisted thoracoscopic surgery (VATS) and robotic-assisted procedures.
While these techniques offer important advantages—including reduced pain, shorter hospital stays, and faster recovery—they may limit the surgeon’s ability to manually feel lung tissue during the operation.
As a result, identifying very small or deeply located tumors can become increasingly difficult.
Real-time molecular imaging offers a valuable solution by providing visual guidance directly within the surgical field.
Earlier clinical studies have already suggested that abenacianine may improve tumor visualization during minimally invasive and robotic-assisted procedures, and the newly published VISUALIZE results further strengthen that evidence.
Favorable Safety Profile
In addition to demonstrating encouraging efficacy, abenacianine continued to exhibit a favorable safety profile.
Investigators reported that the imaging agent appeared safe and well tolerated throughout the study.
Importantly, no drug-related serious adverse events were observed among patients receiving abenacianine.
The favorable safety findings support continued clinical development as the company advances into pivotal Phase 3 evaluation.
Experts Highlight Clinical Importance
Adam Gridley, President and Chief Executive Officer of Vergent Bioscience, emphasized the growing need for technologies that improve intraoperative decision-making as lung cancer surgery continues to evolve.
He stated that helping surgeons visualize cancer in real time has the potential to fundamentally change surgical practice by increasing confidence during tumor removal and facilitating more complete resections.
Gridley also noted that the company believes the technology may ultimately extend beyond lung cancer to support surgery for a wide variety of solid tumors.
In addition, he highlighted ongoing efforts to expand the flexibility of the treatment protocol by evaluating infusion timing up to four days before surgery, providing greater convenience for patients and surgical teams.
Independent Clinical Perspective
The study’s senior author, Dr. Sunil Singhal, Chief of the Division of Thoracic Surgery at the Perelman School of Medicine at the University of Pennsylvania, emphasized the continuing challenges surgeons face despite advances in modern lung cancer surgery.
According to Dr. Singhal, identifying small lesions and ensuring complete removal of all cancerous tissue remain among the most difficult aspects of thoracic oncology.
He explained that the published findings add to an expanding body of evidence supporting intraoperative molecular imaging as a valuable surgical tool capable of enhancing tumor visualization, improving surgical precision, and reducing the likelihood of residual disease following resection.
Phase 3 Development Already Underway
Building upon the encouraging Phase 2B findings, Vergent Bioscience is actively conducting the Phase 3 VISUALIZE-2 clinical trial (NCT07499674).
The multicenter pivotal study is designed to further evaluate the safety and efficacy of abenacianine in a larger patient population undergoing lung cancer surgery.
According to the company, patient enrollment is progressing rapidly across participating clinical centers.
If the Phase 3 study confirms the favorable findings observed in earlier trials, Vergent plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in 2027.
Regulatory approval would represent a major milestone for the company and could introduce one of the first broadly applicable molecular imaging agents designed to improve real-time tumor visualization during cancer surgery.
The publication of the VISUALIZE Phase 2B trial results represents another important milestone in the development of abenacianine as an innovative intraoperative molecular imaging agent. By enabling surgeons to identify tumors that conventional techniques may overlook, the technology has the potential to improve surgical accuracy, preserve healthy tissue, and reduce the likelihood of incomplete tumor removal.
With clinically significant benefits observed in nearly half of the patients studied, a favorable safety profile, and ongoing Phase 3 evaluation, abenacianine continues to demonstrate promise as a next-generation imaging tool for thoracic oncology. As Vergent Bioscience advances toward regulatory submission, the company aims to provide surgeons with a powerful new technology capable of enhancing precision during cancer surgery and improving outcomes for patients with lung cancer and, potentially, many other solid tumors.
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.