Yes. This is deeply encouraging. The addition of IL-2 seems to make a substantial difference - presumably by extending the life and effectiveness of the Azercell CAR-T's.
Only a small sample size - but a great result. Fast Track designation from the FDA would seem highly likely to me, speeding the course to the proposed registrational trial.
Almost as important as the response rate is the safety data. "Treatment with azer-cel to date has been safe and tolerable" - is a great thing to hear. It would be good to see data on the number and level of adverse reactions, but clearly there were no major adverse events.
If Azer-cel can show this kind of response in patients who have failed SOC and multiple other treatments, and do that with solid safety, then it's a winner. And that's before considering the vastly reduced cost of Allogeneic "off the shelf" CAR-T compared to the bespoke individually engineered Autologous CAR-T's currently in use. Also the elimination of the long "wait time" with current Autologous CAR-T's while they are being harvested from the p[atient, then re-engineered and produced in volume - requiring the patient to survive somehow through that long wait period. Also the fact that many patients no longer have T-cells which are sufficiently healthy to be used as source stock for Autologous CAR-T anyway.
All of which is why Allogeneic CAR-T has massive advantages if it can be made to work - and it looks to me as though Precision and IMU have done just that.
Cheers
Dave
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