Vergent Bioscience Initiates Phase 3 VISUALIZE 2 Pivotal Study of Abenacianine (VGT-309) for Tumor Visualization During Lung Cancer Surgery

Pivotal trial will assess ability of abenacianine to reveal malignant tissue during minimally invasive and robotic surgical procedures

MINNEAPOLIS--(BUSINESS WIRE)--Vergent Bioscience, a clinical-stage biotechnology company advancing molecularly targeted intraoperative imaging, today announced the initiation of VISUALIZE 2, a Phase 3, multi-center, pivotal study to confirm the safety and efficacy of abenacianine to visualize tumors during lung cancer surgery. Abenacianine is an investigational tumor-activated, intraoperative imaging agent designed to illuminate malignant tissue in patients undergoing surgery for suspected or confirmed cancer in the lung.

Surgery is a cornerstone of treatment for most solid tumors, including lung cancer. As minimally invasive and robotic-assisted surgery have become best practice, the need for precise intraoperative decision-making and guidance has intensified. Minimally invasive and robotic-assisted surgery have improved numerous outcomes for patients including less trauma, smaller incisions, shorter hospital stays, and faster recovery. However, these approaches remove the surgeon’s ability to directly see and feel tissue, making it difficult to visualize and localize tumors during surgery. Abenacianine is designed to illuminate cancer in real time during surgery, enabling surgeons to make more confident decisions toward the goal of complete oncologic resection. In previous Phase 2 and Phase 2b lung cancer clinical trials, abenacianine provided guidance to improve intraoperative decision-making in 43% and 45% of surgeries, respectively.

“We are excited to advance abenacianine into this next stage of clinical development, working with leading thoracic surgeons, academic institutions, and community cancer centers,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “By revealing malignant tissue undetectable by white light, abenacianine brings molecular intelligence into the operating room, helping surgeons make more confident decisions when precision matters most. We believe abenacianine has the potential to become critical operating room technology as surgery continues to evolve and become more minimally invasive, robotic, and precise.”

The Phase 3 VISUALIZE 2 study is designed to confirm the safety and efficacy of abenacianine for use in lung cancer surgery. This randomized, open-label, multi-center trial will enroll 132 participants at 10 clinical trial sites across the United States and Australia in 2026. Each patient in the study will receive abenacianine as a single, intravenous infusion 12-96 hours before surgery. During the procedure, surgeons will first attempt to localize lesions using standard surgical techniques. Abenacianine with near-infrared (NIR) imaging will then be used to assess tumor presence, with all findings confirmed by histopathologic evaluation.

The primary efficacy endpoint is the proportion of patients with at least one Clinically Significant Event (CSE), defined as the localization of a lung lesion or identification of additional cancer that could not be found with standard surgical techniques.

“Once surgery begins, even the most carefully planned procedures can sometimes be limited by what is visible under white light,” said Sunil Singhal, M.D., William Maul Measey Professor in Surgical Research at University of Pennsylvania Perelman School of Medicine, and principal investigator for the study. “By turning light into molecular insight, abenacianine aims to provide surgeons with actionable, real-time information, and we look forward to confirming if it supports more precise, tissue-sparing decisions.”

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 enables 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.

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