On January 28, 2024 Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, reported new data presented today at the 60th Annual Meeting of The Society of Thoracic Surgeons (#STS2024) (Press release, Vergent Bioscience, JAN 28, 2024, View Source [SID1234639635]). The data demonstrate that VGT-309, the company’s investigational tumor-targeted fluorescent imaging agent, visualizes primary and metastatic tumor tissue in the lung during surgery.

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The findings reinforce results from earlier clinical trials of VGT-309 which suggest the agent may help surgeons see difficult-to-find and previously undetected tumors in real time, ensuring all tumor tissue is removed during minimally invasive (MIS) and robotic-assisted lung cancer surgery.

"The data presented today at STS 2024 suggest that VGT-309 could help support more confident and reliable removal of a wide breadth of cancers in the lung that would otherwise be missed during minimally invasive and robotic surgery," said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. "We look forward to the results from our ongoing, Phase 2 multi-center VISUALIZE study, which will provide further insight regarding the potential promising impact of VGT-309 for both cancer patients and surgeons."

The VGT-309 Phase 2* efficacy study evaluated the frequency that intraoperative molecular imaging (IMI) 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 inadequate surgical margin.

Each patient in the study received VGT-309 preoperatively through intravenous infusion. Following an attempt to localize tumors 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. 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 was safe and well tolerated in this study, with no infusion reactions and no drug-related serious adverse events.

"Minimally invasive surgery has become standard of care for many cancer surgeries, but surgeons’ ability to see and remove all tumor tissue during these procedures is often hindered by poor visualization," 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. "The data from the VGT-309 Phase 2 efficacy study are encouraging, reinforcing the agent’s potential to help fill this critical gap."

*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 imaging agent designed to enable a complete solution for optimal tumor visualization during open, minimally invasive surgery (MIS), and robotic-assisted surgical procedures. VGT-309 is delivered to patients via a short 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 the preferred dye to minimize confounding background autofluorescence.