Vergent Bioscience plans to further investigate its tumour-targeted fluorescent imaging agent VGT-309 in a Phase IIb lung cancer trial, president and CEO Dr John Santini tells Clinical Trials Arena.
The Phase IIb trial will be looking to enrol between 50 to 80 patients who are eligible for standard-of-care (Soc ) lung resection. The multicentre and open-label study is set to start in H2 2023, mostly focussing on US-based sites. Santini shares that adding one or two overseas locations is also being considered.
The enrolled patients will be dosed with VGT-309 between a few hours to a day before their surgery. The surgeon will conduct the procedure using SOC methods and use a near-infrared imaging camera to examine the surgical field and determine where the tumour is.
VGT-309 is a small peptide with two fluorescent dyes, indocyanine green (ICG) and the QC-1 quencher, attached to it. It binds to protease enzymes that are in and around tumours. Once the agent binds tightly to these proteases, it is activated and the fluorescence is viewed using a near-infrared camera, allowing surgeons to better differentiate tumours from normal tissue, Santini explains.
Alongside safety, the trial endpoints will be largely focussing on the proportion of patients who benefit from the agent, Santini says. The benefit to the patient is determined by one of three aspects: the asset helps the surgeon locate a difficult-to-find tumour, the surgeon can identify any positive margins, or metastatic or tumour spread that wasn’t detectable using standard methods is identified.
“We are looking at the endpoint measuring the percentage of patients where the agent can provide a benefit beyond what the surgeon could do just using standard-of-care today,” he explains. Once the Phase IIb is completed, Vergent will move the asset onto the Phase III trial.
Exploring other oncology indications
Vergent is currently focussing on the lung cancer market due to the clinical need for visualisation during lung cancer surgery, but the company plans to explore other cancer indications such as colorectal, breast, gastric, and prostate cancers. “The beauty of VGT-309 is that its target is broad enough that we believe the agent will be able to identify and light up numerous different types of cancers,” the CEO notes.
In the next year, Vergent is also planning to investigate VGT-309 in rectal cancer with grant funding from an academic partner. The imaging agent is currently being investigated in a single-site Phase II study (NCT05400226) which enrolled 40 participants. According to ClinicalTrials.gov, the estimated completion date is February 2023.
Vergent raised $21.5 million in a Series B financing round last month. The funds will be used to complete the current Phase II study and fund the upcoming Phase IIb trial.