There is no hiding from the recent headline in Fierce Pharma, FDA investigates 'serious risk' of secondary cancer following CAR-T treatment.
Picking up the point about the negative reaction to news of the investigation into autologous CAR-T immunotherapies there is presumably a flip side. Reputedly, the investigation does not translate to companies using non-viral autologous approaches for CAR insertion or for allogeneic approaches. The flip side is presumably the positive reaction to such alternative CAR-T approaches e.g. azer-cel. I'm not suggesting a positive reaction by Mr Market but more to do with boardroom activity in Big Pharma land.
For instance, what is the value of azer-cel post investigation. Imugene negotiated the deal back in August but what if the FDA investigation had been announced in the middle of due diligence? Would the terms have been the same or would Big Pharma have begun to knock more urgently on the door of allogeneic drug developers. Was Imugene just lucky or was there a high level of prudential acumen in having closed the deal?
But wait, Imugene have already started a Phase 1 clinical trial with onCARlytics in combination with an approved CD19 drug!!! Its somewhat interesting that they went with a CD19 approved drug that is not an approved CAR-T immunotherapy. It just feels like someone is playing chess and everyone else is playing checkers.
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