IOpener™ – Cancer immunotherapy treatment optimization

IOpener™ – Diagnostic blood test for prediction of response to Immune Checkpoint Inhibitor therapy to be used for treatment and development optimization

IOpener™ – Cancer immunotherapy treatment optimization

IOpener™ – Diagnostic blood test for prediction of response to Immune Checkpoint Inhibitor therapy to be used for treatment and development optimization

Arts vrouw consult Pamgene

ICI Therapy Response Predictor

Despite significant advances in cancer treatment by the use of immune checkpoint inhibitors (ICI) only 20-50% of patients respond to ICI therapy.

PamGene has developed the IOpener™ diagnostic blood test for rapid measurement of protein kinase activity of peripheral mononuclear cells from the blood of patients indicated for treatment with CTLA-4 and/or PD1 ICI therapy. The test provides a predictive score for the likelihood of responding to ICI therapy from a simple blood draw.

The IOpener™ technology will guide physicians in their decision for providing the right ICI treatment without delay, and has the potential to decrease the number of both over- and undertreated patients. Providing ICI therapy to those patients who are most likely to elicit a response will improve overall response rate, reduce unnecessary side effects and help saving costs.

The IOpener™ test 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.

ICI therapy response predictor

Despite significant advances in cancer treatment by the use of immune checkpoint inhibitors (ICI) only 20-50% of patients respond to ICI therapy.

PamGene has developed the IOpener™ diagnostic blood test for rapid measurement of protein kinase activity of peripheral mononuclear cells from the blood of patients indicated for treatment with CTLA-4 and/or PD1 ICI therapy. The test provides a predictive score for the likelihood of responding to ICI therapy from a simple blood draw.

The IOpener™ technology will guide physicians in their decision for providing the right ICI treatment without delay, and has the potential to decrease the number of both over- and undertreated patients. Providing ICI therapy to those patients who are most likely to elicit a response will improve overall response rate, reduce unnecessary side effects and help saving costs.

The IOpener™ test 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.

Arts vrouw consult Pamgene

Individual kinase activity profiles predicting patient response

 

Kinases play a crucial role in immune checkpoint regulation and therefore can predict a patient’s response before immune checkpoint inhibitor (ICI) therapy is started. The response to ICI therapy is driven by an individual patient’s kinase activity profile and can give key information to clinicians in support of treatment decisions.

Positive interim results of multi-cohort study for validation

72 melanoma and 65 NSCLC patients were included in the interim-analysis for the 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, with a Correct Classification Rate of 71% for the melanoma cohort and 70% for the NSCLC cohort.

Predictive performance may improve when combined with existing biomarkers: This is achieved when tyrosine kinase activity profiling is combined with low tumor PD-L1 expression in NSCLC patients, as depicted on the right. Validation of the results in an independent patient cohort is currently ongoing.

 

Progression Free Survival NSCLC patients with PD-L1 expression < 50% HR = 0.23 p = 0.002

Tyrosine kinase activity profiling as a predictive biomarker for clinical benefit to immune checkpoint inhibition in advanced melanoma and NSCLC

K. de Joode, H. Groen, A. van der Veldt, K. Suijkerbuijk, J. de Groot, R. de Wijn, D. Hurkmans, D. van den Heuvel, K. Schmidt, J. Groten, E. Verdegaal, S. van den Burg, M. van den Heuvel, J. Aerts, E. Kapiteijn, R. Mathijssen

ESMO 2020 Poster presentation

From sampling to report in 72 hours

Diagnostic Assay Services Facility

 

PamGene’s ISO13485 compliant Diagnostic Assay Services Facility performs the IOpener™ test as IVD assay service to help targeting the most appropriate treatment for individual melanoma and lung cancer patients. The IOpener™ test is currently available as in-house developed test and is in the final phase of clinical validation for CE-IVD certification.

In-vitro Diagnostic Development

 

Clinical studies in advanced stage Melanoma and Non-Small-Cell Lung Carcinoma (NSCLC) patients with standard of care ICI therapy revealed that the IOpener™ test is a very promising diagnostic tool to predict disease progression in patients treated with PD1 and CTLA4 checkpoint inhibitors.

Clinical validation studies are underway to prepare for IVD certification and new Proof-of-Concept studies are carried out for additional indications for ICI therapy.

Blood-based multiplex kinase activity profiling as a predictive marker for clinical response to checkpoint blockade in advanced melanoma.

D.P. Hurkmans, E.M.E. Verdegaal, S.A. Schindler, E.A. Basak, D.M.A. van den Heuvel, R. de Wijn, R. Ruijtenbeek, J.P. Groten, R. Dummer, S.L.W. Koolen, M.J.P. Welters, R.H.J. Mathijssen, E. Kapiteijn, J.G.J.V. Aerts, M.P. Levesque, S.H. van der Burg

ASCO 2018 Poster presentation

Blood-based multiplex kinase activity profiling as a predictive marker for clinical response to checkpoint blockade in advanced NSCLC.

D.P. Hurkmans, E.M.E. Verdegaal, R. de Wijn, S.L.W. Koolen, C.H.J. Lamers, D.M.A. van den Heuvel, J.P. Groten, R. Debets,  E. Kapiteijn, R.H.J. Mathijssen, S.H. van der Burg, and J.G.J.V. Aerts

WCLC 2019 Poster Presentation

In-vitro Diagnostic Development

 

Clinical studies in advanced stage Melanoma and Non-Small-Cell Lung Carcinoma (NSCLC) patients with standard of care ICI therapy revealed that the IOpener™ test is a very promising diagnostic tool to predict disease progression in patients treated with PD1 and CTLA4 checkpoint inhibitors.

Clinical validation studies are underway to prepare for IVD certification and new Proof-of-Concept studies are carried out for additional indications for ICI therapy.

Poster Presentation:

 

Blood-based multiplex kinase activity profiling as a predictive marker for clinical response to checkpoint blockade in advanced melanoma

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Poster Presentation:

 

Blood-based multiplex kinase activity profiling as a predictive marker for clinical response to checkpoint blockade in advanced NSCLC

Read more

Information for professionals

 

The IOpener™ tests are currently available as in-house developed test via PamGene Diagnostic Assay Services Facility. Clinical studies for use in diagnostic procedures will be finalized in the course of 2020. We are currently preparing IVD certification and closely collaborate with clinical professionals to extend our network in Europe and US. Please contact us if you are interested to learn more.

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Information for
patients

 

The IOpener™ tests are currently available as in-house developed test. We are currently preparing IVD certification. Please contact us or your treating physician if you are interested to learn more.

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Scientific background