Blood-based biomarker test has the potential to decrease the number of both over- and undertreated patients improving overall response rate, reduce unnecessary side effects and help saving costs.
PamGene, a biotech and services company focused on the development and commercialization of multiple novel biomarker panels for patient stratification in immuno-oncology, presented positive interim-results of its current multi-cohort study at ESMO. The study’s objective is to validate the predictive value of PamGene’s diagnostic blood test, the IOpener™, intended for rapid prediction of the likelihood of a patient’s response to immune checkpoint inhibitors (ICI) therapy by tyrosine kinase activity profiling. Based on these very promising results validation studies in combination with existing biomarkers are currently taking place.
Predictive biomarker for ICI tumor response
72 melanoma and 65 NSCLC patients were included in the interim-results for this ongoing multicenter prospective cohort study. Significant differences between tyrosine kinase activity profiles of the progression versus no progression group were observed for both the melanoma and NSCLC cohort showing that this form of profiling serves as a predictive biomarker for tumor response to ICIs.
Further improvement in accuracy could be obtained by combining the tyrosine kinase activity profiles of both cancer types and incorporation with existing biomarkers. The evaluation of these results is currently ongoing. Clinical studies and regulatory approval for diagnostic product will be finalized in the course of 2021. The IOpener™ is currently available as in-house developed test.
“There is an urgent need for a test that enables rapid and accurate prediction of a patient’s response to immune checkpoint inhibitors, as only a minority of cancer patients are eligible for ICI therapy whilst treatment costs of these innovative drugs are very high. The IOpener™ technology, based on the finding that the response to ICI therapy is driven by an individual patient’s kinase activity profile, has the potential to support physicians in their quest to optimize clinical benefit in cancer patients. Additionally, the test may contribute to reducing the number of patients who might suffer from side effects coming from ICI treatment,” says John Groten, Managing Director of PamGene.
About the IOpener™
This blood-based biomarker test is developed to guide oncologists in optimizing patient treatment and to support pharmaceutical companies to improve both efficiency and outcome of their clinical trials by patient stratification from a simple blood draw. This first-of-its-kind diagnostic test is based on tyrosine kinase activity profiling of baseline peripheral mononuclear cells (PBMCs), which play a crucial role in immune checkpoint regulation and T-cell response. In combination with PamGene’s proprietary software algorithms the test requires only 72 hours from sampling to providing an individual patient view of their likelihood of responding to ICI treatment. The IOpener® is currently available as in-house developed test and is in the final phase of clinical validation for CE-IVD certification. Clinical studies and regulatory approval for use in diagnostic procedures will be finalized in the course of 2021.
At PamGene we are dedicated to support physicians and scientists in finding solutions and answers to improve and optimize patient treatment and understand diseases. We have developed a robust and unique microarray technology for multiplex kinase activity profiling and offer dedicated assay services for biomarker discovery, patient stratification and therapy selection for oncological diseases. PamGene is a Dutch biotechnology company founded in 2000 and with headquarters in Den Bosch, the Netherlands.