Completing the Cell Therapy Revolution

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With no specific antigens available and a highly immunosuppressive microenvironment with little blood flow, how will researchers tackle solid tumors and bring cell therapy to millions?

By James Strachan

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In 2017, the pharmaceutical industry erupted in celebration as the FDA approved the first two CAR T-cell therapies, Yescarta and Kymriah. Until then, the prospect of extracting a patient’s cells, modifying them to express chimeric antigen receptors on the surface, and reinfusing them into the patient to latch onto specific antigens to kill tumors had seemed like science fiction to many. But FDA approvals answered the doubters: CAR T works.

However, other questions remained unanswered. Ideal drug manufacturing and logistic processes are closed and automated to eliminate the risks associated with human intervention and manual operations – but this is not the case with autologous CAR T. So how would companies handle living, breathing cells in transit? Would healthcare systems be able to cope? Pricing too was a concern. Would all stakeholders embrace evidence-based pricing?

Though these questions are yet to be fully resolved, we are seeing a conversational shift back to where it all began: scientific efficacy. We know cell therapy works in liquid tumors (leukemia and lymphoma), but what about solid tumors, which represent approximately 90 percent of adult human cancers and, therefore, a huge area of unmet need. In short, what’s the hold up?

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“We all thought solid tumors might be a little bit harder – but how hard could it really be?” asks Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania, and President of the International Society for Cell & Gene Therapy (ISCT). “Quite a lot harder, it turns out”

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This article was created and originally published by The Medicine Maker. To read the full version, visit:


Completing the Cell Therapy Revolution