Groundbreaking Clinical Trial Enables Real-Time Monitoring of Brain Tumors

In the realm of medical advancements, Exvade Bioscience™ has embarked on an innovative clinical trial aimed at addressing the formidable challenge posed by glioblastoma, one of the deadliest forms of brain cancer. The Nationally Recognized Academic Medical Center, Preston Robert Tisch Brain Tumor Center at Duke University, is the site for this significant Phase 1 study that marks a transformative milestone in the treatment of aggressive brain tumors.

About the Trial

The clinical trial, identified as NCT04547777, investigates the efficacy and safety of an innovative device known as the Tumor Monorail™—an FDA Breakthrough Device designed to facilitate real-time monitoring and treatment of recurring glioblastomas. This revolutionary approach leverages a bio-inspired implant that aims not only to guide invasive tumor cells away from critical brain areas but also allows for minimal invasive sampling of live tumor tissue, a feat previously deemed unattainable in treating glioblastoma.

Early results from the trial are promising, showcasing a favorable safety profile. The Tumor Monorail acts as a surgical tool that remains implanted during the treatment process, providing continuous observation of how the tumor responds to the administered therapies. This method addresses a fundamental challenge in treating glioblastoma, wherein clinicians often struggle to dynamically assess changes in tumor biology throughout the course of therapy.

The Innovative Treatment Approach

Patients enrolled in this study are adults aged 18 or older with confirmed recurrent glioblastoma, who have previously undergone standard therapies. Participants will receive a dual therapeutic approach, combining two investigational immunotherapies, D2C7-IT and 2141-V11, along with continuous monitoring enabled by the Tumor Monorail.

D2C7-IT is an immunotoxin targeting both wild-type EGFR and EGFRvIII, proteins that are often overexpressed in glioblastoma cells. This targeted therapy aims to eradicate tumor cells while minimizing damage to healthy surrounding brain tissue. The combination therapy includes an Fc engineered anti-CD40 monoclonal antibody, 2141-V11, which is designed to enhance the immune response triggered by tumor breakdown initiated by D2C7-IT.

In conjunction with the Tumor Monorail, the treatment strategy employs a technique known as convection-enhanced delivery (CED) that effectively bypasses the blood-brain barrier, allowing higher concentrations of treatment to reach the tumor and surrounding tissue. Patients will receive both intratumoral and subcutaneous doses of the investigational therapies, ensuring a robust immune response and continuous monitoring through needle aspiration at each treatment session.

Importance of Real-Time Monitoring

“The ability to monitor tumor dynamics in real time presents a significant breakthrough in glioblastoma treatment,” said Dr. Annick Desjardins, the principal investigator of the study. “By understanding how the tumor reacts to therapy as it unfolds, we can make more informed decisions about the efficacy of our interventions, ultimately obviating the need for repeated invasive surgical procedures.”

This trial introduces a vital aspect of tumor sampling, often referred to among experts as the ‘holy grail’ in glioblastoma clinical development. The need for timely and accurate insights into tumor biology has been a significant barrier in progressing effective treatments for patients. By utilizing the Tumor Monorail, Exvade believes it can fundamentally accelerate the pace at which new and potentially effective therapies are brought to fruition for patients battling glioblastoma.

Conclusion

As the trial progresses, its outcomes hold the potential to dramatically inform the future of glioblastoma care. While the standard treatment protocol has remained static, often leading to poor prognosis, the findings from this study could catalyze a shift, paving the way for more personalized, effective therapeutic strategies.

For those interested in learning more about participation criteria and the trial, visit the official clinical trial listing at ClinicalTrials.gov. This investigation symbolizes a significant step forward for neuro-oncology, aiming to change the narrative surrounding one of the most challenging forms of cancer today.