Periodic Reporting for period 2 - ROUTINE (canceR agnOstic immUnoTherapy predIctioN blood-tEst)
Okres sprawozdawczy: 2024-08-01 do 2025-07-31
Cancer is the second leading cause of death worldwide, accounting for 10 million deaths in 2020. Although a new class of cancer medications, Immune Checkpoint Inhibitors (ICIs), has been approved for different cancer indications and represents a true breakthrough, only 10–50% of advanced cancer patients respond to the treatment. This unpredictability of results, together with risks of adverse effects and high costs, restricts the overall impact potential of ICIs. Predicting patient responses to these treatments is therefore critical to fully realizing their potential.
PamGene’s IOpener® is a ground-breaking diagnostic test designed to predict patient response to these cancer medications (ICIs). Made possible by PamGene’s proprietary technology, which analyses kinase activity in patient immune cells, the test can predict a patient’s response to ICI therapy before treatment start, using only a simple blood draw.
As part of the ROUTINE project, PamGene has:
- Further developed the IOpener® platform into a standardized and easily implementable solution applicable to melanoma and non-small cell lung cancer, while integrating new data types (multi-omics biomarkers) to further improve test results towards an Iopener® test that can be applied to a range of cancer indications.
- Started a clinical utility interventional study of the IOpener®-melanoma test in the Netherlands and a clinical utility study observational study in Germany. Furthermore, the study design has been completed for a clinical observational study on the clinical utility of the IOpener®-NSCLC test. In addition, initial studies towards health and economic benefit of the IOpener tests have been completed which will be updated with the real-world data from the clinical utility studies. This evidence will be used to support market access and reimbursement by health insurers.
- PamGene’s has prepared its marketing & sales organization for the start of commercialization and has implemented logistical workflows for the further commercialization of the IOpener® platform.
PamGene’s IOpener® is a ground-breaking diagnostic test designed to predict patient response to these cancer medications (ICIs). Made possible by PamGene’s proprietary technology, which analyses kinase activity in patient immune cells, the test can predict a patient’s response to ICI therapy before treatment start, using only a simple blood draw.
As part of the ROUTINE project, PamGene has:
- Further developed the IOpener® platform into a standardized and easily implementable solution applicable to melanoma and non-small cell lung cancer, while integrating new data types (multi-omics biomarkers) to further improve test results towards an Iopener® test that can be applied to a range of cancer indications.
- Started a clinical utility interventional study of the IOpener®-melanoma test in the Netherlands and a clinical utility study observational study in Germany. Furthermore, the study design has been completed for a clinical observational study on the clinical utility of the IOpener®-NSCLC test. In addition, initial studies towards health and economic benefit of the IOpener tests have been completed which will be updated with the real-world data from the clinical utility studies. This evidence will be used to support market access and reimbursement by health insurers.
- PamGene’s has prepared its marketing & sales organization for the start of commercialization and has implemented logistical workflows for the further commercialization of the IOpener® platform.
The main ROUTINE project achievements up to date are as follows:
• IOpener®-Sample Collection Kit has been developed and registered as an in-vitro diagnostic device under the new IVDR regulation and now can be used for sample collection for IOpener tests.
• IOpener®-melanoma clinical utility study in Germany has been started and is actively enrolling patients.
• IOpener®-melanoma clinical study in the Netherlands has received Ethics Committee approval, in compliance with both CTR and IVDR regulations, and is scheduled to start patient recruitment in Q4 2025.
• IOpener®-Sample Collection Kit has been developed and registered as an in-vitro diagnostic device under the new IVDR regulation and now can be used for sample collection for IOpener tests.
• IOpener®-melanoma clinical utility study in Germany has been started and is actively enrolling patients.
• IOpener®-melanoma clinical study in the Netherlands has received Ethics Committee approval, in compliance with both CTR and IVDR regulations, and is scheduled to start patient recruitment in Q4 2025.
The current IVD blood kinome tests in melanoma and lung cancer developed by PamGene are novel and beyond state of the art, as demonstrated by the patent applications that have been carried out in collaboration with clinical collaborators. The clinical utility studies that have been started in this ROUTINE program are needed for reimbursement of the test and will further support the beneficial health and economic benefits of IOpener®-melanoma and IOpener®-NSCLC tests.
Furthermore, the development of IOpener pan cancer test and the muti-modal biomarker analysis, are underway, which, when successful, will lead to new patent applications and the expansion of the IOpener® product portfolio.
Furthermore, the development of IOpener pan cancer test and the muti-modal biomarker analysis, are underway, which, when successful, will lead to new patent applications and the expansion of the IOpener® product portfolio.