2141-V11

- Trial investigates the FDA Breakthrough device "Tumor Monorail," a paradigm-shifting approach for tracking and treating recurring glioblastoma, one of the deadliest cancers, in real time - DURHAM, N.C., Jan. 6, 2026 /PRNewswire/ -- Exvade Bioscience™, a clinical-stage neuro-oncology company advancing a breakthrough platform for treating aggressive brain cancers, today highlighted ongoing enrollment in a Phase 1 clinical trial (NCT04547777) at the Preston Robert Tisch Brain Tumor Center at Duke University. Early results indicate a favorable safety profile for Exvade's Tumor Monorail™, an FDA Breakthrough Device designed to provide physicians with safe, real-time access to brain tumors and their evolving microenvironment throughout treatment. The trial marks the first-ever use of a bio-inspired implant designed to guide invasive brain-tumor cells away from critical brain regions toward a designated 'safe zone', outside of the brain, while also enabling repeated, minimally invasive sampling of live tumor tissue – once thought unattainable in glioblastoma (GBM), which is one of the most aggressive and treatment-resistant brain cancers. By enabling longitudinal access to tumor biology without repeat surgeries, Exvade aims to address a fundamental barrier to effective GBM treatment: the inability to dynamically assess tumor response to therapy over time. The Phase 1 study is enrolling adults with recurrent glioblastoma (GBM) who have undergone prior standard therapy to evaluate a novel dual approach that combines two investigational immunotherapies (D2C7-IT and 2141-V11) with advanced tumor monitoring using Exvade's Tumor Monorail. The surgically implanted catheter system is placed at the tumor site and remains in place throughout treatment, enabling continuous monitoring of tumor evolution and response to treatment. The trial includes two key components: one focused on evaluating the safety and feasibility of the Tumor Monorail for monitoring tumor during treatment in adult patients with recurrent glioblastoma, and the other - testing a combination therapy that delivers two experimental drugs, D2C7-IT in combination with an Fc engineered Anti-CD40 Monoclonal Antibody, directly into the tumor and surrounding tissue to target cancer cells more precisely. D2C7-IT is an investigational immunotoxin designed to target and bind to both wild-type EGFR and EGFRvIII, two proteins frequently overexpressed in glioblastoma cells. This targeted therapy is intended to destroy tumor cells while minimizing damage to healthy brain tissue. D2C7-IT is administered in combination with 2141-V11, a fully-human anti-CD40 agonist antibody, which potentiate the immune response from the tumor breakdown initiated by D2C7-IT. In this study, the Tumor Monorail is first inserted in proximity to the tumor recurrence, after which, D2C7-IT and 2141-V11 are administered directly into the intracerebral tumor using convection-enhanced delivery (CED)—a method that bypasses the blood-brain barrier to allow high concentrations of drug to reach tumor-infiltrated regions, after which, patients undergo repeated dosing of 2141-V11 subcutaneously in the upper neck area (cervical perilymphatic area). The initial intracerebral administration of D2C7-IT and 2141-V11 is intended to initiate a tumor breakdown and immune activation, while the repeated dosing of 2141-V11 in the cervical perilymphatic area aims to maintain a strong immune response. The Tumor Monorail is accessed by subcutaneous needle aspiration at each dosing of the 2141-V11 in the cervical perilymphatic area, allowing real time evaluation of the tumor status. "By allowing real-time monitoring of the tumor over time, while on therapy, we will hopefully be able to more swiftly identify the degree of efficacy or the limitations of our therapies, while preventing the trauma and costs of repeated brain surgery," said Dr. Annick Desjardins, MD, FRCPC, neuro-oncologist, professor of neurosurgery and neurology at Duke University and the study's principal investigator. "Serial tumor sampling remains one of the most critical unmet needs - and what many consider the holy grail - in glioblastoma therapeutic development and clinical advancement" said Nassir Mokarram, co-inventor of Tumor Monorail and co-founder of Exvade Bioscience. "Many clinical trials today struggle to confirm whether therapies are effectively reaching the tumor, producing meaningful biological effects, or overcoming emerging resistance. We believe effective treatments for many glioblastoma patients may already exist - but progress has been constrained by the lack of timely, accurate, and actionable insight into the tumor and its microenvironment. Tumor Monorail has the potential to dramatically accelerate the pace at which new treatments are validated, optimized and personalized for patients." Eligibility Criteria Include: Adults aged 18 or older with histologically confirmed recurrent glioblastoma Tumor recurrence after prior standard therapy (surgery, radiation, chemotherapy) This study represents a paradigm-shifting step toward more personalized and precise treatment of brain tumors. To learn more about the study and eligibility, visit the official clinical trial listing: About Glioblastoma Glioblastoma is the most common and devastating primary malignant brain tumor in adults. With an incidence of approximately 3.2 per 100,000 population in the USA, approximately 12,300 people are diagnosed with a glioblastoma yearly. Standard of care for the treatment of glioblastoma is typically 'maximal safe' surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy with or without the Optune® device. There is currently, no standard of care treatment at the time of tumor recurrence, which leads to a median survival from initial diagnosis of less than 21 months. About Exvade Bioscience Exvade Bioscience is a clinical-stage medical technology company operating at the intersection of device innovation, therapeutics, and personalized medicine. Starting in neuro-oncology, the Tumor Monorail technology enables real-time, repeatable access to tumor biology and introduces a fundamentally new concept: guiding and moving tumor cells- rather than relying solely on destroying them - to enable safer intervention and new therapeutic strategies that support personalized medicine. While neuro-oncology serves as the entry point, the platform is designed to expand to other hard-to-treat solid tumors and to enable precision medicine through localized and targeted drug delivery. Built on high-impact scientific evidence and extensive preclinical validation, the platform has now entered clinical translation - marking a pivotal step toward broader oncology applications. The Tumor Monorail breakthrough platform has been supported in part by the National Institutes of Health (NIH), Ian's Friends Foundation (IFF), and the Marcus Foundation. Learn more at exvadebio.com. About The Preston Robert Tisch Brain Tumor Center The Preston Robert Tisch Brain Tumor Center conducts groundbreaking research and offers innovative treatment for brain tumors. It is dedicated to caring for pediatric and adult patients and their families, improving their quality of life, and ultimately finding a cure for brain tumors. Forward Looking Statements This press release contains forward looking statements that involve risks and uncertainties. All statements other than statements of historical fact are forward looking statements, including statements regarding the potential benefits, safety, and performance of the Tumor Monorail Device, the progress and results of the clinical trial, and future development and regulatory plans. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. The Tumor Monorail Device and the investigational therapies described remain under clinical investigation and are not approved for commercial use. Exvade Bioscience undertakes no obligation to update any forward looking statements except as required by law. Contact Sean Meehan [email protected] 404-487-8283 SOURCE Exvade Bioscience, Inc. 21% more press release views with Request a Demo