Senti Bio Announces Updated SENTI-202 Clinical Data from Ongoing Phase 1 Trial in Relapsed or Refractory Acute Myeloid Leukemia Patients, Demonstrating Deep, MRD Negative, Durable Complete Remissions and a Favorable Safety Profile

Core Insights - Senti Biosciences, Inc. announced new data from its clinical trial of SENTI-202, a CAR NK cell therapy for relapsed or refractory Acute Myeloid Leukemia (R/R AML), showing promising efficacy and safety results [1][3][5] Efficacy and Safety Data - The open-label study reported a 50% Overall Response Rate (ORR) and a 42% Complete Remission (CR) or CR with Partial Hematologic Recovery (CRh) among patients, with 100% of CRs and approximately 80% of all responses being minimal residual disease (MRD) negative [2][3][4] - The median duration of composite Complete Remission across all patients was 7.6 months, with some responses lasting over a year [4] - SENTI-202 demonstrated a favorable safety profile, with no dose-limiting toxicities or serious adverse events related to the therapy [4][5] Mechanism of Action - SENTI-202 utilizes a Logic Gate mechanism to selectively target and kill AML blasts and leukemic stem cells while sparing healthy hematopoietic stem and progenitor cells [3][4][12] - The therapy showed potent killing of AML blasts, even in patients with high baseline levels of disease [4] Regulatory Designations - The FDA granted SENTI-202 Regenerative Medicine Advanced Therapy (RMAT) designation, indicating its potential to address serious unmet medical needs [3][5][13] - SENTI-202 also received Orphan Drug Designation, further supporting its development for R/R hematologic malignancies [5][13] Future Development Plans - The positive clinical data and regulatory designations position Senti Biosciences to advance SENTI-202 into pivotal studies and explore its use in broader patient populations, including newly diagnosed AML and pediatric AML [6][9]