Vergent Bioscience Data Published in The Annals of Thoracic Surgery Demonstrate VGT-309 May Help Surgeons Visualize Tumor Tissue in the Lung During Surgery
18 Julio 2024 - 7:30AM
Business Wire
Phase 2 study of tumor-targeted fluorescent
imaging agent met primary efficacy endpoint, showing VGT-309 helps
surgeons see tumor tissue missed by standard surgical
techniques
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.
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