VGT-309

MINNEAPOLIS--( BUSINESS WIRE )-- 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 less, 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. About Vergent Bioscience, Inc. Vergent Bioscience is a clinical-stage biotechnology company that is helping surgeons realize the full potential of minimally invasive and robotic-assisted surgery by improving the visibility of tumors. Vergent’s lead compound, abenacianine for injection, is a tumor-targeted fluorescent imaging agent designed to enable surgeons to see difficult-to-find or previously undetected tumors in real-time during surgery, so that they can ensure all tumor tissue is removed. The company is first evaluating abenacianine for cancer in the lung, with the potential to expand its application to a wide range of solid tumors. Vergent Bioscience is a privately held company based in Minneapolis, MN. References: Bou-Samra P., et al. Phase 2 Clinical Trial of VGT-309 for Intraoperative Molecular Imaging During Pulmonary Resection. Ann. Thorac Surg. (2024). doi:10.1016/j.athoracsur.2024.05.019

MINNEAPOLIS--( BUSINESS WIRE )-- Vergent Bioscience , a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced completion of patient enrollment in the company’s Phase 2, multi-center VISUALIZE trial, evaluating the efficacy and safety of abenacianine for injection (VGT-309) in patients with cancer in the lung. Abenacianine for injection is a novel, investigational tumor-targeted fluorescent imaging agent designed to improve the visibility of difficult-to-find and previously undetected tumors during minimally invasive and robotic-assisted surgical procedures. “The VISUALIZE trial will provide additional, valuable insights illuminating the potential of our novel imaging agent to address existing deficits in tumor visualization during lung surgery,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “Completing enrollment in the trial is an exciting milestone that reflects our team’s dedication, as well as the commitment of the VISUALIZE clinical investigators and study participants. We look forward to sharing the results of this study.” Data from previous clinical studies of abenacianine for injection suggest the agent allowed surgeons to see tumor tissue during minimally invasive surgery (MIS), including robotic-assisted surgical procedures, providing “molecular sight” and potentially increasing their confidence in MIS. For the Phase 2 VISUALIZE trial, investigators at six sites in the United States and Australia enrolled 89 patients with cancer in the lung, all of whom received 0.32mg/kg abenacianine for injection as a short infusion 12 to 36 hours prior to surgery. Following data readout from the VISUALIZE trial, Vergent intends to advance the agent into a Phase 3 study. Assuming positive Phase 3 results, the company will file a new drug application (NDA) for abenacianine for injection for cancer in the lung. About Lung Cancer Surgery Approximately 25% of all U.S. lung cancer patients undergo lung cancer surgery, which can be a curative treatment if lung cancer is diagnosed early, and all tumor tissue is removed. 1 MIS and robotic-assisted surgery methods are increasingly utilized in lung cancer resection because these approaches are associated with shorter hospital stays, smaller incisions, less blood less, and decreased post-operative complications. While these are important advantages, MIS and robotic-assisted surgery often compromise surgeons’ sight and ability to feel tissue during procedures, making it difficult for them to distinguish tumors from normal tissue and ensure all tumor tissue is removed. About the VISUALIZE Clinical Trial The Phase 2, multi-center, open-label VISUALIZE study ( 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 study received 0.32mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor 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. Primary efficacy endpoints included visualization 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 (VGT-309) Abenacianine for injection is a tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization during open, minimally invasive and robotic-assisted surgical procedures. Abenacianine for injection is delivered to patients via a short intravenous 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, would provide distinct clinical advantages and position abenacianine for injection as an ideal tumor imaging agent. Abenacianine for injection’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 a preferred dye to minimize confounding background autofluorescence. About Vergent Bioscience, Inc. Vergent Bioscience is a clinical-stage biotechnology company that is helping surgeons realize the full potential of minimally invasive and robotic-assisted surgery by improving the visibility of tumors. Vergent’s lead compound, abenacianine for injection, is a tumor-targeted fluorescent imaging agent designed to enable surgeons to see difficult-to-find or previously undetected tumors in real-time during surgery, so that they can ensure all tumor tissue is removed. The company is first evaluating abenacianine for injection for cancer in the lung, with the potential to expand its application to a wide range of solid tumors. Vergent Bioscience is a privately held company based in Minneapolis, MN. Lu T, et al. "Trends in the incidence, treatment, and survival of patients with lung cancer in the last four decades," Cancer Manag Res. 2019 Jan 21;11:943-953. https://pubmed.ncbi.nlm.nih.gov/30718965/