FDA Grants Fast Track to Vergent's VGT-309 for Lung Tumor Visualization During Surgery

MINNEAPOLIS--Vergent Bioscience, a biotechnology firm focused on the development of tumor-targeted imaging agents, has achieved a significant milestone with the U.S. Food & Drug Administration (FDA) granting Fast Track designation to their investigational fluorescent imaging agent, abenacianine for injection (VGT-309). This innovative agent is designed to aid intraoperative visualization of primary lung cancer, other pulmonary lesions, cancerous lymph nodes, and positive surgical margins during surgeries for lung cancer.

John Santini, Ph.D., President and CEO of Vergent Bioscience, expressed optimism about this development. He emphasized that the FDA’s Fast Track designation reaffirms abenacianine's potential to enhance lung cancer surgeries, particularly by improving surgeons’ ability to visualize tumors during minimally invasive procedures. Santini further highlighted Vergent Bioscience's commitment to working closely with the FDA to bring abenacianine to surgeons and patients as swiftly as possible.

The adoption of minimally invasive surgery (MIS) and robotic-assisted techniques in lung cancer procedures is on the rise due to advantages such as reduced hospital stays, smaller incisions, minimized blood loss, and fewer post-operative complications like chronic pleural pain. Despite these benefits, these surgical methods can sometimes hinder surgeons' ability to distinguish tumors from healthy tissue. Emerging data from clinical studies suggest that abenacianine can bolster surgeons' confidence in these procedures by ensuring comprehensive tumor removal.

In a Phase 2 efficacy study (NCT05400226), results published in The Annals of Thoracic Surgery demonstrated that abenacianine effectively visualized primary and metastatic tumor tissues in the lung during surgery. The agent was also found to be safe and well-tolerated. The study's primary endpoint focused on the proportion of patients experiencing at least one clinically significant event (CSE), which includes locating elusive tumors, identifying positive surgical margins, and uncovering previously undetected tumors that might have been overlooked using standard visual and palpation techniques. Among the 40 participants who received abenacianine and underwent standard surgical resection for suspected lung cancer, 43% (n=17) experienced at least one CSE.

Vergent Bioscience has recently concluded patient enrollment in the Phase 2, multicenter VISUALIZE study (NCT06145048), which assessed the efficacy and safety of abenacianine in patients undergoing lung cancer surgery. The company is planning to initiate patient enrollment for the Phase 3 confirmatory VISUALIZE-2 study in 2025.

Fast Track designation from the FDA is granted to expedite the development and review of drugs intended to treat serious conditions with unmet medical needs. Drugs with this designation can benefit from increased communication with the FDA and a rolling submission process for marketing applications, potentially leading to expedited approval and faster access for patients in need of new therapies.

Vergent Bioscience, based in Minneapolis, MN, is a clinical-stage biotechnology company dedicated to advancing the capabilities of minimally invasive and robotic-assisted surgeries by improving tumor visibility. Their leading compound, abenacianine for injection, is specifically designed to assist surgeons in identifying difficult-to-locate or previously undetected tumors in real-time during surgery, ensuring comprehensive tumor removal. Initially focused on lung cancer, Vergent Bioscience envisions expanding the application of abenacianine to various solid tumors.