VGT-309

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/

MINNEAPOLIS--( BUSINESS WIRE )-- Vergent Bioscience , a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that data published in The Annals of Thoracic Surgery reinforce the clinical potential of VGT-309, the company’s investigational intraoperative molecular imaging (IMI) agent, to help surgeons see difficult-to-find and previously undetected tumors in the lung during surgery. The findings support previous clinical trial results suggesting that VGT-309 could help ensure all tumor tissue is removed during minimally invasive and robotic-assisted surgical procedures. “The expanded use of minimally invasive surgery, including robotic-assisted technologies, for lung cancer has created a significant and growing need for better visualization during these surgeries, which can be curative when lung cancer is diagnosed early enough and all tumor tissue is removed,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We are pleased that data from our clinical program continue to suggest VGT-309 may help overcome existing challenges to tumor visualization and thereby optimize surgical outcomes for physicians and patients.” The Phase 2* efficacy study evaluated the frequency that IMI with VGT-309 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 identification of inadequate surgical margin. Each patient in the study received VGT-309 preoperatively through intravenous infusion. Following an attempt to localize the target lesion using standard surgical techniques, investigators used a commercially available near infrared (NIR) endoscope to visualize the lesion, which was then assessed 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 appeared safe and well tolerated in this study, with no infusion reactions and no drug-related serious adverse events. “While the prevalence of minimally invasive surgery has increased over the years, these surgical approaches require surgeons to work in a small area with a restricted view and limited tactile clues, increasing the possibility that tumor tissue will be difficult to locate or even missed,” said study investigator and senior author Sunil Singhal, M.D., chief of the Division of Thoracic Surgery in the Perelman School of Medicine at University of Pennsylvania. “The study findings published today in The Annals of Thoracic Surgery add to the growing body of evidence suggesting that VGT-309 has the potential to provide meaningful benefit to both surgeons and cancer patients during minimally invasive surgery.” To further evaluate the efficacy of VGT-309, Vergent is currently conducting the Phase 2 multicenter VISUALIZE study ( NCT06145048) . Investigators at six sites in the United States and Australia plan to enroll 100 patients in this Phase 2 study, which Vergent expects to complete by the end of 2024. *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 fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization during open, minimally invasive and robotic-assisted surgical procedures. VGT-309 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, 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 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, VGT-309, 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 VGT-309 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.