Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for the company’s novel, investigational tumor-targeted fluorescent imaging agent, abenacianine for injection (VGT-309), as an adjunct for the intraoperative visualization of primary lung cancer, other pulmonary lesions, cancer containing lymph nodes, and positive surgical margins in patients undergoing surgery for known or suspected cancer in the lung.
“Receiving Fast Track designation from the FDA reinforces the potential of abenacianine to address existing deficits in lung cancer surgery by helping surgeons better visualize tumors in the lung during minimally invasive surgical procedures,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.”
Minimally invasive surgery (MIS) and robotic-assisted surgery methods are increasingly utilized in lung cancer resection because they are associated with benefits such as shorter hospital stays, smaller incisions, less blood loss, and decreased post-operative complications, including chronic pleural pain. However, these approaches often limit surgeons’ ability to distinguish tumors from normal tissue. Data to date from clinical studies have shown that abenacianine has the potential to build confidence in these procedures by helping surgeons to ensure all tumor tissue is removed.
Findings from a Phase 2 efficacy study (NCT05400226) published in The Annals of Thoracic Surgery demonstrated that abenacianine visualized primary and metastatic tumor tissue in the lung during surgery and was safe and well-tolerated. The primary efficacy endpoint was the proportion of patients with at least one clinically significant event (CSE), defined as locating difficult-to-find tumors, identifying positive margins, and finding previously undetected tumors that may otherwise have been missed using standard visual and palpation methods. Of the 40 participants administered abenacianine who underwent the standard-of-care surgical resection for suspected lung cancer, 43% (n=17) had at least one CSE.1
Vergent recently completed enrollment in the Phase 2, multicenter VISUALIZE study (NCT06145048), which evaluated the efficacy and safety of abenacianine in patients undergoing surgery for proven or suspected cancer in the lung. The company will begin enrollment in the Phase 3 confirmatory, multicenter VISUALIZE-2 study in 2025.
The FDA grants Fast Track designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A drug that receives Fast Track designation can benefit from early and frequent communication with the agency, in addition to a rolling submission of the marketing application, with potential pathways for expedited approval that have the objective of getting important new therapies to patients more quickly.
