A Phase 2, Multi-center, Open-label Study to Evaluate the Safety and Efficacy of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent, in Subjects Undergoing Surgery for Cancer in the Lung

This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing surgery for proven or suspected cancer in the lung. Approximately 100 subjects will be enrolled to ensure at least 86 subjects are evaluable with the option to expand enrollment by protocol amendment if deemed necessary by the DSC to meet primary and/or secondary objectives.

Start Date05 Oct 2023

Sponsor / Collaborator

Vergent Bioscience, Inc.Startup

NCT06034197 / RecruitingEarly Phase 1IIT

Pilot Open Label Study to Determine the Safety and Efficacy of Fluorescent Probe, VGT-309, to Identify Cancerous Colorectal Lesions During White-Light and Fluorescence Augmented Colonoscopy

The purpose of this study is to determine the safety and feasibility of VGT-309 for the visualization of colorectal tumors in real-time using near-infrared (NIR) fluorescence endoscopy. In addition, signatures of 50+ biomarkers will be evaluated in biopsies using CODEX multi-plexing.

Start Date27 Sep 2023

Sponsor / Collaborator

Stanford University

NCT05400226 / CompletedPhase 2

A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Lung Cancer Surgery

A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.

Start Date24 May 2022

Sponsor / Collaborator

Vergent Bioscience, Inc.Startup

[+1]

100 Clinical Results associated with VGT-309

100 Translational Medicine associated with VGT-309

100 Patents (Medical) associated with VGT-309

Literatures (Medical) associated with VGT-309

01 May 2024·The Annals of Thoracic Surgery

Phase 2 Clinical Trial of VGT-309 for Intraoperative Molecular Imaging During Pulmonary Resection

Article

Author: Kennedy, Gregory T ; Santini, John T ; Guo, Emily ; Bou-Samra, Patrick ; Chang, Austin ; Azari, Feredun S ; Singhal, Sunil ; Bensen, Eric S ; Din, Azra

BACKGROUNDAdvances in intraoperative molecular imaging (IMI) may improve surgical outcomes when resecting tumors in the lung. A single-center trial was conducted using VGT-309, a cathepsin-targeted near-infrared imaging agent that causes lung nodules to fluoresce during surgical resection. The end point of this phase 2 study was to evaluate the frequency that IMI with VGT-309 resulted in a clinically significant event (CSE): localization of pulmonary nodules, discovery of unsuspected additional cancers, or identification of positive margins.METHODSPatients undergoing surgical resection for known or suspected cancer in the lung received VGT-309 (0.32 mg/kg) preoperatively. During the surgical procedure, localization and resection of the nodules were performed using standard surgical techniques. Near-infrared imaging was then used to localize nodules, seek occult lesions, and assess resection margins. Efficacy was measured by the frequency of CSEs.RESULTSOf the 40 patients who underwent pulmonary resection with VGT-309, 17 (42.5%) had at least 1 CSE. Near-infrared imaging identified lesions not found by standard surgical methods in 16 patients, additional cancers not found by preoperative imaging in 1 patient, and margins within 5 mm of the closest staple line in 2 patients. VGT-309 performance was tested across a broad range of tumor types and commercial near-infrared imaging systems. VGT-309 appeared safe, well-tolerated, with no infusion reactions, and no drug-related serious adverse events.CONCLUSIONSThis phase 2 study demonstrated the utility of IMI with VGT-309 in localizing pulmonary nodules, recognizing synchronous lesions, and identifying positive margins. A multi-institutional study will further evaluate the efficacy of VGT-309.

01 Dec 2023·Translational Lung Cancer Research

Cathepsin detection to identify malignant cells during robotic pulmonary resection

Article

Author: Jarrar, Doraid ; Guo, Emily ; Azari, Feredun ; Chang, Austin ; Santini, John T ; Bou-Samra, Patrick ; Kennedy, Gregory ; Singhal, Sunil ; Bensen, Eric S

BackgroundIntraoperative molecular imaging (IMI) uses a fluorescent probe to identify occult cancers. VGT-309 is a quenched activity-based probe that is activated in the presence of cathepsins, enzymes overexpressed in cancer cells, and detected by near-infrared (NIR) light. This study aims to evaluate the sensitivity and the positive predictive value (PPV) of robotic-assisted thoracic surgery (RATS) with intraoperative molecular imaging (RIMI) using VGT-309 to localize tumors using NIR light to detect areas with increased cathepsin activity. Our secondary outcome was to compare RIMI to video-assisted thoracic surgery (VATS) with intraoperative molecular imaging (VIMI).MethodsIn a phase 2 clinical trial at the University of Pennsylvania, patients (n=10) with suspicious pulmonary lesions underwent RATS. First, white light was used followed by RIMI to identify tissues with increased cathepsin activity. Then, VIMI was performed to compare the sensitivity and PPV in identifying the cathepsin activity. The resected specimens were then evaluated for fluorescence and underwent histopathological analysis for cathepsin expression. Image analysis was performed using ImageJ software. Statistical analysis was conducted using IBM SPSS Statistics software. A P value of 0.05 or less was considered significant.ResultsRATS with white light identified 6 out of the 10 pulmonary nodules, whereas adding RIMI identified an additional 4 more pulmonary nodules. RIMI and VIMI were able to detect the same 8/10 (80%) nodules. The addition of VIMI did not identify any lesions that RIMI may have missed. The mean fluorescence intensity of tumors visualized by RIMI was 115.81 A.U. [standard deviation (SD) =58.57] compared to 95.6 A.U. (SD =14.81) by VIMI (P=0.41). The mean tumor-to-background ratios (TBR) of tumors visualized by RIMI was 9.20 (SD =9.12) compared to 2.29 A.U. (SD =1.11) using VIMI (P=0.1). The sensitivity of RIMI and VIMI was 88.9% which was superior to that of RATS (55.6%). The PPV of RATS was 83.3% compared to 100% in RIMI and VIMI.ConclusionsRIMI is a valuable option for visualization of occult disease using VGT-309-guided IMI through identifying areas of increased cathepsin activity. In this small series, RIMI and VIMI showed clinical equivalence in sensitivity and PPV of detecting cathepsin activity.

12 Jun 2023·Research square

Preclinical Lymph Node Model for Intraoperative Molecular Imaging of Cancer.

Author: Azari, Feredun ; Bou-Samra, Patrick ; Kennedy, Gregory ; Segil, Alix ; Chang, Austin ; Guo, Emily ; Singhal, Sunil ; Arambepola, Sachinthani

PurposeLymph node(LN) dissection is part of most oncologic resections. Intraoperatively identifying a positive LN(+ LN), that harbors malignant cells, can be challenging. We hypothesized that intraoperative molecular imaging(IMI) using a cancer-targeted fluorescent prober can identify + LNs. This study aimed to develop a preclinical model of a + LN and test it using an activatable cathepsin-based enzymatic probe, VGT-309.ProceduresIn the first model, we used peripheral blood mononuclear cells (PBMC), representing the lymphocytic composition of the LN, mixed with different concentrations of human lung adenocarcinoma cell line A549. Then, they were embedded in a Matrigel^® matrix. A black dye was added to mimic LN anthracosis. Model two was created using a murine spleen, the largest lymphoid organ, injected with various concentrations of A549. To test these models, we co-cultured A549 cells with VGT-309. Mean fluorescence intensity(MFI) was. An independent sample t-test was used to compare the average MFI of each A549:negative control ratio.ResultsA significant difference in MFI from our PBMC control was noted when A549 cells were 25% of the LN (p = 0.046) in both 3D cell aggregate models-where the LNs native parenchyma is replaced and the one where the tumor grows over the native parenchyma. For the anthracitic equivalents of these models, the first significant MFI compared to the control was when A549 cells were 9% of the LN (p = 0.002) in the former model, and 16.7% of the LN (p = 0.033) in the latter. In our spleen model, we first noted significance in MFI when A549 cells were 16.67% of the cellular composition.(p = 0.02).ConclusionsA + LN model allows for a granular evaluation of different cellular burdens in + LN that can be assessed using IMI. This first exvivo + LN model can be used in preclinical testing of several existing dyes and in creating more sensitive cameras for IMI-guided LN detection.

News (Medical) associated with VGT-309

18 Jul 2024

·www.businesswire.com

Vergent Bioscience Data Published in The Annals of Thoracic Surgery Demonstrate VGT-309 May Help Surgeons Visualize Tumor Tissue in the Lung During Surgery

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.

Clinical ResultPhase 2

28 Jan 2024

·www.drugs.com

Vergent Bioscience Presents Phase 2 Data Showing VGT-309 Visualizes Tumors in the Lung During Surgery

MINNEAPOLIS, Minn., January 28, 2024 – Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced new data presented today at the 60th Annual Meeting of The Society of Thoracic Surgeons (#STS24). 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. 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. 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 surgery by significantly 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. Vergent Bioscience Australia Pty Ltd is a wholly owned subsidiary of Vergent Bioscience. Source: Vergent Bioscience, Inc. Posted: January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 2Clinical Result

17 Jan 2024

·www.biospace.com

Vergent Bioscience to Present New Efficacy Results from Phase 2 Clinical Trial of VGT-309 at Annual Meeting of The Society of Thoracic Surgeons

STS 2024 session will highlight potential of tumor-targeted fluorescent imaging agent to enhance minimally invasive surgery by improving the visualization of cancer in the lung MINNEAPOLIS--(BUSINESS WIRE)-- Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that new results from the Phase 2 clinical program evaluating the company’s investigational agent VGT-309 will be presented at STS 2024, the 60th Annual Meeting of The Society of Thoracic Surgeons, taking place January 27-29, 2024, in San Antonio, Texas. “Our VGT-309 clinical program has produced an encouraging body of evidence demonstrating the potential of our highly differentiated imaging agent to improve standard of care surgery for patients with cancer in the lung,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We look forward to sharing the latest data from this program with the surgical and medical research communities at STS 2024.” The Phase 2 single-center clinical efficacy study of VGT-309 was led by Sunil Singhal, M.D., William Maul Measey Professor in Surgical Research at University of Pennsylvania Perelman School of Medicine. The study involved 40 participants who underwent surgical resection for known or suspected cancer in the lung.* Findings to be presented at STS 2024 build upon results from earlier Phase 1 safety and Phase 2 dose-ranging clinical trials of VGT-309 demonstrating the agent’s potential to help surgeons see difficult-to-find and previously undetected tumors in real time to improve surgical outcomes. Following are details about the VGT-309 presentation at STS 2024: Title: A Phase 2 Clinical Trial of VGT-309, a Quenched Activity-Based Probe for Intraoperative Molecular Imaging of Pulmonary Malignancies Presenter: Patrick Bou-Samra, M.D., Division of Surgery, University of Pennsylvania, Perelman School of Medicine Session: General Thoracic. At the Cutting Edge: Emerging Technologies in Lung Cancer Date/Time: Sunday, January 28, 2024, 2:40 p.m. – 2:52 p.m. CT *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. About Vergent Bioscience Vergent Bioscience is a clinical-stage biotechnology company that is helping surgeons realize the full potential of minimally invasive and robotic surgery by significantly 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. Vergent Bioscience Australia Pty Ltd is a wholly owned subsidiary of Vergent Bioscience. For more information, visit vergentbio.com

Phase 2

100 Deals associated with VGT-309

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Indication	Highest Phase	Country/Location	Organization	Date
Secondary malignant neoplasm of lung	Phase 2	AU	Vergent Bioscience, Inc.Startup	05 Oct 2023
Secondary malignant neoplasm of lung	Phase 2	US	Vergent Bioscience, Inc.Startup	05 Oct 2023
Lung Cancer	Phase 2	AU	St. Vincent's Hospital Melbourne Pty Ltd.	11 Sep 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05400226 (CTgov)	Phase 2	Lung Cancer	40	VGT-309 (VGT-309 0.32mg/kg IV Given 12-36 Hours Prior to Surgery)	zgyppzfzah(bgwhpzaizs) = bephhzkbpl bzmeclziju (jtqlqbtpgn, njvrnynfjy - fbhtaxntka) View more	-	17 Oct 2024
NCT05400226 (CTgov)	Phase 2	Lung Cancer	40	VGT-309 (VGT-309 0.32mg/kg)	dcpnkwilbe(bbjsckrzme) = ucooyederi wkfkeydkrv (rxcqwhlewa, azmozjfslz - zuehqtfijr) View more	-	17 Oct 2024
NCT05400226 (BusinessWire) Manual	Phase 2	Lung Cancer	40	VGT-309	rvgtfxzncw(qmmnoayccl) = fldqsbolwk nbdvtrgrfy (czsbeoasez ) Met	Positive	18 Jul 2024
NCT05400226 (NEWS) Manual	Phase 2	Lung Cancer	40	VGT-309	(qrjatfxjof) = dcyizuizak vnwgrvfjli (acvbakuxpw )	Positive	28 Jan 2024
WCLC2023 Manual	Phase 2	Lung Cancer	27	VGT-309	kvklwusucj(hmghcdxhef) = At 0.16mg/kg VGT-309, all cancerous lesions from participants dosed the day prior to surgery fluoresced both in situ and ex vivo, but none of the tumors from participants dosed on the same day had fluorescence in situ. At maximum dose of 0.32mg/kg at either interval, 12 of 15 confirmed cancers fluoresced, both in situ and ex vivo. ihrnxubvbw (yopnmbbrbl )	Positive	11 Sep 2023

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