Kibur Medical provides a path to personalized therapies for treatment of high-grade gliomas
Glioblastoma (GBM) is one of the most aggressive human malignancies, with an average survival of 12 to 15 months after diagnosis. There are currently few molecular biomarkers for predicting therapy response, and there is a large heterogeneity of tumoral cell populations in GBM. For these reasons, the Kibur microdevice technology is an effective way to establish the benefit of experimental treatments in a personalized manner. Patient response to standard-of-care temozolomide (TMZ), the primary adjunct chemotherapy treatment, is 20-30%. Therefore, a key question is whether a molecular measurement can identify TMZ responders and for those non-responders, are there potential alternative chemotherapy drugs from which they could benefit?
To demonstrate its safety and efficacy for this approach, the Kibur device was used in a Phase 1 clinical trial at Brigham and Women’s Hospital in Boston, MA. The device was inserted into the tumors of 6 patients at the start of surgery and remained in place until the tumor was fully resected (approximately 2-3 hours). During that time, nanodoses of FDA-approved chemotherapy drugs, including TMZ, were released into the GBM in a spatially confined manner and in therapeutic concentrations in the tissue immediately adjacent (0.5 – 1mm) to the point of release. After tissue collection and processing, various markers were used to assess the effect of each drug on tumoral tissue. All patients in the study were treated with TMZ so it presented the opportunity to compare intratumoral response to TMZ with systemic response. Notably, microdevice intratumoral response to TMZ accurately predicted systemic response and for the TMZ non-responders, the Kibur device successfully demonstrated which drugs responded best to specific tumor types, and which molecular markers can be utilized to predict therapy response.
The main goals of this study were to demonstrate that the Kibur device can be easily incorporated into standard neurosurgical practice with minimal impact to the operative protocols, adds no significant burden to healthcare costs, and results in no evidence of adverse effects, while providing valuable biological data which can be integrated with, and potentially be superior to other currently used biomarkers. This Phase 1 study successfully met all of those goals, establishing the potential for a future trial that can use the drug response from the microdevice to select patient therapies.
The entire publication can be found here. An overview of this trial is also described by the Principal Investigator, Dr. Pieraolo Peruzzi, in a presentation hosted by the American Brain Tumor Association (www.abta.org) on novel treatments and clinical rials for low grade gliomas: Novel Treatments and Clinical Trials for Low Grade Gliomas – YouTube.
To learn more about Kibur’s innovative microdevice, please visit our website and visit us at booth 2242 at the upcoming AACR conference April 14-19, 2023.