Today's Challenges in Cell Therapy

 

Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Marty Giedlin, VP of Development at Sangamo BioSciences, Inc. Marty discusses key industry challenges, the evolution of the cell therapy field and where it is headed in the next five years, advancements in technology and much more. Below is a brief excerpt from the podcast, follow the links below to access the complete podcast and transcript.

Listen to the podcast | Access the complete transcript

What are the challenges that you’re experiencing in your industry?

Well, I guess it really depends on what kind of cell therapy you’re talking about. We at Sangamo are processing both autologous T-cells and autologous stem cells. We have the most experience in our T-cell program where we knock out the CCR-5 receptor for HIV in HIV-positive patients. So, the challenges are trying to find that patient population that’s most amenable to this type of therapy, both in viral load, how many years they’ve been in retroviral therapy and that sort of thing. And also finding out which of the CD4 cells – which sub-population – is most important in controlling HIV. So, those are some of the challenges that are facing us there.

With our stem cell program, we have a partnership with CIRM (California Institute for Regenerative Medicine) in California with the City of Hope where we are looking at using CD34 stem cells either from peripheral blood or from bone marrow. What sub-population of those cells are really those that have the capacity for self-renewal over time? Those are the cells that we really want to target to do our gene modification technology.

Then, there are culture conditions to minimize replication, retain stemness and maximizing engraftment with respect to CD34s. And then we’re looking at ways of mobilizing peripheral blood CD34s and how does that affect stemness with respect to CD34s? And then also looking at different ways of bone marrow harvest. So, are there better ways of getting maximal yield to make sure we get enough cells to give back to the patient?

So, for us in the adoptive cell therapy, those are some of the challenges that we’re looking at over the next three to five years.

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Changes Ahead in Cell Therapy

The field of cell therapy has traditionally resided more within the academic sphere.  However, over the last two to three years, we’ve seen a shift where big pharma has become much more involved.  This change has left many speculating about the implications on the industry going forward.  Marty Giedlin, VP of Development with Sangamo BioSciences, will be discussing some of these implications at the Cell Therapy and Bioprocessing conference.  He recently shared a few thoughts with us on this shift in cell therapy going forward:

Overall, how do you see cell therapy changing within the next five years?

Marty: Well, I think it’s going to go to more solid tumor targets and more epithelial tumors because that’s the hardest nut to crack. I think that’s where people want to go – the breast cancers, the colon cancers and their related metastases because that provides a big challenge in how you get --- I mean, you could maybe find T-cells or TILs within those tumors, but how do you get T-cells into those tumors because of just the physiological make-up of solid tumors, their ability to regulate the immune response and other factors that sort of limit adoptive cell therapy effects? I think we have some of the antibodies out there like anti-CTLA-4 and PD-1 and others that can sort of overcome some of the immunosuppressive activities of tumors. So, I think it’s going to be more of a matrix of immunotherapies that’s going to have to attack solid tumors. Besides the cells, there is cytokine support or antibody support. So, I think it’s going to be more academic and big pharma coming together. How can we put these individual therapeutics together to exact a clinical response?

I think the other thing – particularly with respect to cell therapies – is more automation. People tend to think of this as a culture flask business sort of thing. But, I think with the innovations by Miltenyi and their Prodigy platform and other companies coming in with better plastics and bags and just cell handling. I think it’s going to be much more get-it-out-of-the-lab and more of a --- I don’t want to say industrial, but more of a rapid hands-off sort of way of producing these cells. The goal is like what you want to do, depending on your source. You want to basically hand the bag of the raw cells from either the apherisis product or a bone marrow, tap a button and come back a couple of hours later and get the bag of your – in our case – gene modified selected cells to then route to the patient. So, I think those types of things are going to make it much more accessible to a lot of people, as well.

The last thing is, what more can we actually do to characterize the product, particularly with adoptive cell therapy? More people are going for a population approach to taking cells, modifying them and giving them back. But some sub-populations of cells really have activities that you want to give back to the patient to get the best results. So, I think more interest is going into respect to being able to phenotype these cells, do proteome analysis, look at RNA expression of cell populations and so forth. I think that’s really going to make things a little easier as far as targeting the cell population that’s going through the most difference going forth. That could be easier for us because if it’s a smaller population of cells, it has expansion capability – whatever – then its few cells that we have to process and it makes things easier on our end, as well.

Download the brochure for the Cell Therapy and Bioprocessing conference to check out Marty's full interview.

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