Cell Therapy Advances – Several Hurdles Remain
Contributed by Derrick Rancourt, professor in the Cumming School of Medicine, University of Calgary
Alberta became the third jurisdiction in Canada, after Ontario and Quebec, to allow cell therapy in the treatment of some forms of cancer, namely lymphocytic cancers. Cell-based therapy (CBT) is proving more effective than conventional cancer therapeutic approaches. The approach has proved successful but more work remains to be done to improve the treatment’s success and reduce the cost.
The form of CBT approved is an immunotherapy that modifies a type of white blood cell called a T-cell for recognizing, targeting, and destroying cancer cells more effectively. Scientists harvest the T-cells from people, then alter them so that they can recognize cancer cells. Doctors then infuse the resulting cells into patients to attack their tumors.
Recently, the US Food and Drug Administration (FDA) approved two products, Yescarta and Kymriah. Yescarta successfully treats large B-cell lymphoma, while Kymriah, treats acute lymphoblastic leukemia. This move by the FDA marks the beginning of a new era for CBTs, which is the fastest growing segment of the global biotech sector. Cell-based therapies are estimated to reach $180B annually by 2030.
At $400,000 per patient, Minister Shandro, Minister of Alberta Health, indicates that Yescarta and Kymriah will be initially available for 60 patients per year. While there is some tolerance for higher pricing with these first-generation technologies, the current costs cannot be sustainable in the long run.
Demand is expected to increase and more cell therapy treatment options are expected to come online in the coming years. The challenge is to develop manufacturing strategies that can produce clinically effective cell quantities reliably and economically.
Critics of personalized medicine have warned that approaches such as CBT will be too expensive to implement on a larger scale. Cell therapy products are living tissues that need to be patient-matched to prevent a host-immune response and rejection. As such, one-size fits all cell therapy products cannot be mass produced in the traditional sense; the end-product needs to be customised for each patient.
One way economies of scale can be achieved for individualized cell therapy products is through mass customization. This requires the bio-banking and reproduction of precursor cells, which are subsequently modified in the laboratory. In Japan 90% of the Japanese population is covered by bio-banked precursor cells. Alberta’s contribution to the development of cell therapies is significant. It has pioneered the development of bioreactors for the mass production of precursor cells.
Cell therapies have been cited for some years as a promising treatment for degenerative diseases prevalent in an aging population such as Parkinson’s disease. Progress in the application of cell-based therapies continues to be of great interest to the general population and healthcare industry.
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I appreciate this article and its update on this important development