PamGene: blood-based biomarkers to predict patient treatment response to immune checkpoint inhibitors

PamGene is a Dutch biomarker services company in Den Bosch that offers scientific research services to academic centres and pharma companies using a proprietary peptide microarray platform, helping cellular kinase signalling analysis in cancer and immune related disorders. They have now developed this platform into an in vitro diagnostic (IVD) test that can predict a cancer patient’s response from a simple blood draw, before ICI (immune checkpoint inhibitors) therapy is started.

Pictured: John Groten, Managing Director at PamGene.

PamGene and Catalyze have enjoyed a successful collaboration for several years on multiple projects, most recently culminating in PamGene’s €7.5M award (€2.5 million grant, €5 million equity) from EIC Accelerator for the ‘ROUTINE’ project. We spoke with John Groten, Managing Director, to hear more about PamGene’s IOpener^TM platform, how it will make impact for patients and clinicians alike, and Catalyze’s support in their innovation journey.

Addressing cancer immunotherapy

Cancer is the second leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. There are currently 7 immune checkpoint inhibitors (ICI) approved for different cancer indications, but only about 10-50% of advanced cancer patients respond well to these biologicals. The variations in response, combined with severe toxicity and high prices per patient restrict the further expansion of ICI. Predicting the patient’s ICI response is critical for fully realizing their potential in treating early-stage tumours and enhancing ICI treatment regimens.

PamGene, with its diagnostic blood-based testing platform, IOpener^TM, can predict a patient’s response before ICI therapy is started, all with a simple blood sample that is taken in the hospital before treatment starts. The IOpener^TM will impact the precision-medicine biomarker sector, enabling the further widespread use of ICIs at any cancer stage.

John explains PamGene’s approach, “We have a biomarker approach to diagnostics to help guide immunotherapy. When considering optimized ICI treatments, you can look at a patient’s native immune system in the white blood cells and evaluate how the cells will react to immunotherapy beforehand, or you can look at the tumour tissue of the patient and look at tumour-specific markers related to ICI treatment. We decided to look at patient immune system side and work from the blood. Our test is non-invasive and very easy in a standard-of-care setting. You can get, essentially, a photograph on cell signalling right at the beginning that can help guide those patients, optimizing their treatment whilst avoiding side effects.

“Of course, there is no single biomarker that will be successful, you have to look at the patient from both angles, from the tumour side and also from the blood. By combining this clinical data, you can make the best choice for that particular patient. We are now carrying out clinical utility studies to assess the proper use of monotherapy before escalation towards combination immunotherapy is needed.”

Progressing from proof-of-concept to clinical utility studies towards market

Catalyze and PamGene have enjoyed an effective long-term collaboration since first working together during the Eurostars project, ‘PRECISE’, now in its final year, in which PamGene is a consortium partner. Since then, the collaboration has yielded successful applications to Eurostars (‘MAINLINE’ project) and to EIC Accelerator for the ‘ROUTINE’ project.

John explains how these projects are each addressing specific challenges:

“In our earlier projects like PRECISE and MAINLINE we have developed proof-of-concept studies for new indications (bladder, multi targets) and this also helps to further finetune our CE-IVD accredited product in lung cancer and melanoma. So the main difference in ROUTINE, our new EIC project, is that we are now carrying out real clinical utility studies in Germany, in France and the Netherlands to test the use of the IVD blood test in real practice. These clinical studies are labour intensive and very expensive and EIC Accelerator gives us the beautiful opportunity to get these studies carried out in Europe and to help reimbursement of the blood test in these countries.

“We are making really good progress and that is also our experience of working with Catalyze. It has been a successful collaboration because we have transparent communication, and we work through the hurdles together. That’s also why we decided to move ahead with the ROUTINE project and develop this proposal together again with Catalyze. And luckily we did as we succeeded in one submission. Quite a great achievement for the two teams.”

IOpener^TM clinical utility studies underway

Under their EIC Accelerator project, ROUTINE, PamGene are conducting a number of clinical utility studies in melanoma and lung cancer. With IOpener^TM, PamGene can deliver the first IVDR accredited blood-based biomarker to help optimize and personalize the use of ICI treatment.

“We are working on the implementation of the test in melanoma patients in Germany, Switzerland and in the Netherlands, and assessing the health effects and economics of ICI’s with such a blood test. We are always considering in here, what is the need from the doctor’s and patient’s perspective? And how can we help them to incorporate this blood test into their standard practice at the best price? We really want to help decide what is a good therapy for that particular patient.

“Currently there are no accredited blood-based biomarkers implemented. Of course there will be more tests coming along and for new indications, but for now we offer the first blood test that is fully validated in a blind and prospective patient cohort study in NSCLC and Melanoma to guide the proper use of immunotherapy.”

Strategic discussions with Catalyze

The decision to apply to EIC Accelerator was made last year, following strategic discussions together with Catalyze. As John points out, beyond the grant writing support, it is these conversations between PamGene and Catalyze that bring extra value to the ongoing collaboration.

“Taking these moments to look ahead together is something we really value about the collaboration. Already more than a year ago, Catalyze looked with us strategically at what is on the agenda for PamGene in the European research grant schedule, and how we could best approach the next steps in the development of IOpener^TM. Resultantly we decided to go ahead with developing the EIC Accelerator application together with Catalyze.”

John continues, “After working together for several years, we have learnt a lot about each other and how to work effectively with the individual advisors. It’s a people’s game. So Catalyze knows the direction we are going, and how many years it takes to get there. Catalyze knows sometimes better than we do what opportunities are coming up in the European Research Agenda and how this could fit for us. That’s the win-win in here as well”.

Learn more about PamGene

Learn more about Catalyze