CAR-T therapies have been proved to be a giant scientific leap forward in the treatment of cancer. However, with growth in the number of approved CAR-T therapies as well as physician and patient demand, the hellishly high cost of CAR-T threatens to torpedo its chance of wide-spread adoption.
The following excerpt from an article in
The American Journal of Managed Care provides some insight into current costs of CAR-T therapy
The CAR T-cell therapy field is still in its infancy and available real-world cost data are limited, but several studies have estimated total costs of care to be between $450,000 and $480,000, with one study estimating total costs to far exceed $500,000 in patients with severe CRS (grade ≥3). However, there is growing appreciation in the field that the actual total cost of care may be closer to $1 million or even $2 million. The American Society for Transplantation and Cellular Therapy has advised hospitals administering CAR T-cell therapy to bill 4 to 5 times the price of the drug, or $2 million to $2.5 million, to avoid losing money. *As Steve Yatomi-Clarke has previously stated, he’s not interested in making incremental changes – he wants to change the CAR-T game.
If you think about it, no matter how brilliant and cutting-edge the science is and no matter how fantastic the results, exorbitant costs will quickly render CAR-T therapies unaffordable. Which is why Prescient, with an eye to the future, is paying as much attention to improving the affordability of CAR-T as it is to solving its scientific challenges.
The first way in which Prescient’s OmniCAR approach tackles costs is through its binding system. Binders can be administered to address antigen escape, rather than having to repeatedly manufacture new doses of T-cells. Having a single T-cell production run has the potential to dramatically reduce CAR-T costs.
View attachment 4613527In addition, Prescient has reduced the amount of binder that is needed to achieve desirable therapeutic effect. V3 OmniCAR has demonstrated potency with 60 fold less binder, meaning lower COGs.
View attachment 4613530A third way in which OmniCAR trims costs is by controlling "rogue" CAR-T activity through controlling the dose of binder. With OmniCAR’s On/Off switch capability, the dose of CAR-T cells given to the patient can be titrated to an effective level that limits toxicity. Cytokine release syndrome and neurotoxicity associated with CAR-T therapies frequently land patients in hospital and in ICU units and these hospitalization costs dramatically add to the overall costs associated with these therapies.
The primary cause of hospitalization for outpatients or transfer to an intensive care unit (ICU) as an inpatient is cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). According to a multicenter historical cohort study of 111 patients treated with CAR T-cell therapy at 7 medical centers in the United States who were admitted to the ICU, CRS was the primary cause of admission in 41% of cases, with overlapping CRS and ICANS present in 60% of patients.*Finally, as announced today, Prescient is further seeking to significantly reduce the cost of CAR-T manufacturing by developing a new, non-viral vector platform with Thermo Fisher Scientific. Current CAR-T manufacturing methods, using viral vectors, involve large amounts of manual work. Consequently, ~25% of operating expenses for CAR-T is estimated to be driven by labour.* As per today’s announcement
All CAR-T therapies approved by the FDA so far, and most CAR-T therapies in development, employ viral vectors to insert genetic material into immune cells to create chimeric antigen receptors (CARs)- expressing immune cells. Viral vectors are expensive, relatively inefficient and very time consuming to develop, often representing a key bottleneck and major cost contributor to CAR-T manufacturing.Furthermore, viral transduction processes are highly complex manual processes which are challenging for tech transfer, labour intensive and prone to operator variations, therefore producing highly variable and unpredictable results….The agreement’s development plan will evaluate the potential of utilizing automated, closed cell therapy solutions to develop a novel process of manufacturing cell therapies on the OmniCAR platform using non-viral methods.The methodical way in which Prescient is piecing together a platform to address all the current limitations of CAR-T, as well as improve its efficacy, is truly impressive.
https://www.ajmc.com/view/improving-outcomes-and-mitigating-costs-associated-with-car-t-cell-therapy
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