Senti Bio receives FDA Orphan Drug Designation for SENTI-202 CAR NK therapy in AML

Senti Biosciences, Inc.

FDA granted Orphan Drug Designation to SENTI-202 for relapsed/refractory hematologic malignancies, including AML.
SENTI-202 is a first-in-class Logic Gated CD33 OR FLT3 NOT EMCN CAR NK cell therapy.
Phase 1 trial (NCT06325748) is ongoing; median survival for relapsed/refractory AML is 5.3 months.
Designation provides tax credits, FDA fee exemptions, and potential 7-year market exclusivity.
Approximately 20,800 new AML cases per year in the US, with 60% relapsing or dying within 12 months.

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