Cell-Based NIPD: Where Are We Now and Where Are We Going?

Kaitlyn Waters:
Hello everyone. Welcome to this podcast from Cambridge Healthtech Institute for Molecular Diagnostics Europe, which runs from April 10th to the 13th, 2017 in Lisbon, Portugal. I'm Kaitlyn Waters, Associate Conference Producer. We have with us today one of our speakers from the Biomarkers for Immunotherapy Conference, Thomas Kleen, PhD, Executive Vice President at Epiontis.

Dr. Kleen, thank you for joining us today.

Thomas Kleen:
Hello, good morning. Thank you to Cambridge Health for having me.

Kaitlyn Waters:
One of your focuses is in immune monitoring for immunotherapy trials. Can you talk a bit more about the focus of your work?

Thomas Kleen:
Yes, that's correct. I should possibly point out in the beginning that Epiontis focus actually is in general immune monitoring. This would include autoimmune diseases or more generally speaking, all inflammatory diseases as well as some vaccine related projects.

Immune monitoring of immunotherapy trials indeed is a large focus of the company. This is certainly caused to an extent by the explosive growths of the immune-oncology, immunotherapy field itself, and that it's now generally accepted that the immune system and therefore immune cells as a biomarker play or even the key role in the successful fight of cancer.

 

For lifelong immunologists like me it's worth noting that acceptance of immunotherapy did not generally happen till 2010 when the FDA approved the first cancer vaccine Provenge for castration resistant prostate cancer. Checkpoint inhibitors like CDL4, PD-1 and PD-L1, are the basis for much of the progress we have made recently, specifically in melanoma and lung cancer. Including with the help of immune monitoring, we need to apply this knowledge and what we've learned from these treatments to other cancer types.

 

Kaitlyn Waters:
You have a unique insight into the field with your involvement with the SITC FDA immunotherapy biomarkers taskforce. What would you say are the top priorities right now for immune-oncology biomarkers?

Thomas Kleen:
In regards to my work with the Society for Immunotherapy of Cancers, Immune Biomarker Taskforce I should mention that this is the second time that the taskforce members have met. We already had one biomarkers taskforce from 2009 to 2012, but the Biomarkers Taskforce reconvened in 2014 until the present date due to the advances that have been made in cancer immunotherapy, including positive results from clinical trials that I have mentioned earlier and in testing new agents and combinations as well as there is a focus on emerging new technologies for measuring these aspects of immunity where Epiontis’ technology is one of them.

Current focus of the taskforce is to review the state of the identify count hurdles for the success and make accommodations to the field again. Topics being addressed actively right now from the different working groups are validation of candidate biomarkers, so identifying the biomarkers to classify different patients and how they respond.

Addition to the identification of most prompts in technologies to actually monitor the immune responses as well as testing of high-throughput immune signatures, and an investigation of how the pre-treatment of the tumor microenvironment might influence the outcome.

Kaitlyn Waters:
Do you think that companion diagnostics will be important for future immunotherapies?

Thomas Kleen:
I do believe in areas where only part of the patients will respond based on the clearly defined targets which a therapy uses. Yes, it will be important to stratify patient populations and find the ones that are most likely to respond to any given therapy.

Kaitlyn Waters:
What do you think are some of the key challenges in biomarker discovery as we move forward?

Thomas Kleen:
The word biomarker in this space is often used a bit as a buzz word and I believe quite broadly. I would like to start and define the meaning a bit before we move to what the challenges are with biomarkers. The divisions in biomarker in general is: a biomarkers and biological molecule entity found in blood, body fluids, or tissues that is a sign of a normal/abnormal process, specifically in relation to a known condition or disease.

In that sense a biomarker may be used to see how well a patient responds to a given treatment and hopefully will enable us to adjust or change individual treatments in the future if the patient is not of what we would call the right pass. The key challenge is that basic and clinical science have not yet fully identified immune markers that correlate with successful cancer treatment, and the protection against recurrence like it has done for many infectious diseases, for example, after vaccination.

Different types and stage of cancer likely will have different correlates of signature of the right or for beneficial immune response. We believe that in general a hot tumor is beneficial. This means there are more inflammatory immune cells versus suppressed immune cells in tumor. We still have to answer some of the big questions by doing detailed immune monitoring in large patient populations in blood and tissue during clinical trials to really answer the more detailed questions and different answers.

For example, of the useful immune biomarkers in the blood it is much easier to obtain than trying to get biopsies from tumors. For example, MDSC’s that are theorized to predict outcome. If we have those questions it could be hugely beneficial to the patients since one could intervene early and target treatments if immune monitoring would show the immune system is not responding in a way that would indicate a positive response.

Kaitlyn Waters:
Great, thank you so much for your time and your insights today Dr. Kleen.

That was Thomas Kleen, PhD, Executive Vice President of Epiontis. He'll be speaking at the Biomarkers For Immunotherapy Conference, a part of the upcoming Molecular Diagnostics Europe, which runs from April 10th to the 13th in Lisbon, Portugal. If you'd like to hear him in person go to www.moleculardxeurope.com for registration information and enter the key code podcast. I'm Kaitlyn Waters, thank you for listening.