With eyes on first allogeneic CAR-T approval, Precision touts 100% response in 'small niche' population
Precision BioSciences has grand regulatory ambitions for its lead program: first allogeneic CAR-T therapy on the market, but the biotech will have to shore up safety concerns of its drug as four deaths were reported in a Phase I/IIa trial.
En route to meeting with the FDA later this year on potential registration strategy, the North Carolina biotech is out with new interim Phase I/IIa clinical data on its prized possession, dubbed PBCAR0191. The anti-CD19 candidate is being tested in patients with relapsed or refractory aggressive lymphomas.
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