Periodic Reporting for period 1 - ROUTINE (canceR agnOstic immUnoTherapy predIctioN blood-tEst)
Reporting period: 2023-08-01 to 2024-07-31
Cancer is the second leading cause of death worldwide, accounting for 10M deaths in 2020. Although a new class of cancer medications (Immune Checkpoint Inhibitors (ICI)) are approved for different cancer indications and have represented 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 prices are restricting the impact potential of ICIs. Predicting patient responses to these treatments is critical for fully realizing their potential.
PamGene’s IOpener® is a ground-breaking diagnostic test to predict patient response to these cancer medications (ICI). Made possible by PamGene’s proprietary technology that assesses patient immune cells, it can predict a patient’s response before ICI therapy is started from a simple blood draw.
As part of ROUTINE project, PamGene will:
• Further develop IOpener® platform into an standardized and easy implementable platform that can be used for all tumour types. We will also add new data types (multi-omics biomarkers) to further improve our test results.
• Perform clinical studies of our current IOpener® tests for lung cancer (NSCLC) and skin cancer (melanoma) to demonstrate test performance, and health and economic benefits. This information will be used to support placing IOpener tests on the market, and achieving reimbursement by health insurances.
• Prepare PamGene M&S organization and and logistal workfkow for further commercialization of the IOpener® platform.
PamGene’s IOpener® is a ground-breaking diagnostic test to predict patient response to these cancer medications (ICI). Made possible by PamGene’s proprietary technology that assesses patient immune cells, it can predict a patient’s response before ICI therapy is started from a simple blood draw.
As part of ROUTINE project, PamGene will:
• Further develop IOpener® platform into an standardized and easy implementable platform that can be used for all tumour types. We will also add new data types (multi-omics biomarkers) to further improve our test results.
• Perform clinical studies of our current IOpener® tests for lung cancer (NSCLC) and skin cancer (melanoma) to demonstrate test performance, and health and economic benefits. This information will be used to support placing IOpener tests on the market, and achieving reimbursement by health insurances.
• Prepare PamGene M&S organization and and logistal workfkow for 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 study in Germany has been started and is actively enrolling patients.
• IOpener®-melanoma clinical study in the Netherlands has been submitted to the Ethics Committee and is expected to start later this year.
• 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 study in Germany has been started and is actively enrolling patients.
• IOpener®-melanoma clinical study in the Netherlands has been submitted to the Ethics Committee and is expected to start later this year.
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 furtherdemonstrate the health and economic benefits of IOpener®-melanoma tests.
Furthermore, the development of IOpener pan cancer test and the muti-modal biomarker analysis, when successful, may lead to new patent applications in the second year of this ROUTINE program.
Furthermore, the development of IOpener pan cancer test and the muti-modal biomarker analysis, when successful, may lead to new patent applications in the second year of this ROUTINE program.